In general, any equipment, drug, device, and/or supply that has not received marketing approval (permission for commercial distribution) from the United States (U.S.) Food and Drug Administration (FDA) is considered experimental, investigational and/or unproven.
Any equipment, drug, device, and/or supply that has received marketing approval but the equipment, drug, device and/or supply is not being used for the purpose or manner for which it was initially rendered, is considered experimental, investigational and/or unproven.
Any equipment, drug, device, and/or supply that has not been manufactured according to established FDA standards, regulations and/or procedures, is considered experimental, investigational and/or unproven.
In some cases, the off-label use of equipment, drugs, devices, and/or supplies may be considered eligible for benefit coverage. Those instances, along with determination of coverage criteria, are addressed in separate Health Care Services Corporation (HCSC) Medical Policies. When a separate HCSC Medical Policy is not found for the off-label use of a drug, refer to RX503.001, Off-Label Use of FDA Approved Drugs.
Special Comment: FDA review and approval of devices only addresses safety of the device. The FDA does not address efficacy. Therefore, HCSC does not necessarily recognize benefit coverage for FDA approved devices unless well-designed controlled studies in the peer-reviewed medical literature demonstrate efficacy and improved health outcomes from use of the device.
What is the Food and Drug Administration (FDA)?
The mandate of the FDA is to regulate, by approving, labeling, and monitoring, the numerous medical products in an expeditious, yet thorough evaluation of the product's safety and effectiveness in meeting the labeling claims. The process is handled by FDA review teams to recommend approval of a product. Following approval, safety teams determine whether the product is hurting an individual. Under current law, the FDA must approve all drugs and devices before they can be marketed. Although the process may be known as the FDA testing program, the FDA does very little of the testing. The developer of a new drug or device uses its own lab or hires another private company to conduct animal tests on the product for safety before proceeding to clinical trials. Generally, these tests are often conducted by a medical school department or consulting firm. When each phase of the testing is completed, the developer submits details of the testing process, evidence of adherence to FDA protocols, and the test results to the FDA.
What is the FDA History?
The FDA grew from a single chemist, part of the U.S. Department of Agriculture in 1862, to the current agency's multilevel and staffed field offices and laboratories.
• 1867 – The Division of Chemistry began investigating adulteration of agricultural commodities.
• 1883 – Began to review misbranding of food and drugs, rather than "anything goes" manufacturing and distribution.
• 1887 – Expanded the division's research by a ten-part study on Foods and Food Adulterants, to prevent impure products from making it to the American public. Unfortunately, any regulations enacted from the reviews and research did not carry any penalties and quality checks to protect the American public from products placed on the market.
• 1901 – Changed to the Bureau of Chemistry.
• 1906 – Passage of the Federal Food and Drug Act to add regulatory functions to the scientific mission.
• 1927 – The Bureau of Chemistry reorganized into two separate entities: Regulatory functions located in the Food, Drug, and Insecticide Administration, and non-regulatory research in the Bureau of Chemistry and Soils.
• 1930 – The name of the Food, Drug, and Insecticide Administration was shortened to Food and Drug Administration (FDA) under the Agricultural Appropriations Act.
• 1938 – Congress enacted the Federal Food, Drug, and Cosmetic Act (FD&C Act) to ensure public safety and establish the FDA.
• 1940 – FDA moved from the Department of Agriculture to the new Federal Security Agency.
• 1951 – FDA classified drugs or products as available by either over-the-counter (OTC) distribution or by prescription only.
• 1953 – FDA transferred directly to the Department of Health, Education, and Welfare (HEW).
• 1968 – FDA shifted within HEW under the Public Health Service.
• 1976 – As a result of a legislative plan to review devices in 1970, the Medical Device Amendment was passed to provide the FDA with sufficient authority to protect the public health with respect to medical devices.
• 1980 – When education was removed from HEW, the FDA was under the Department of Health and Human Services, part of the Executive Office branch of the U.S. Government. FDA acquired formal regulatory authority over devices, equipment, and supplies.
• 1990 – The FDA passes laws banning "gifts of substantial value" from drug companies to physicians. However, minor gifts, such as meals, tickets, and travel, are not banned. In addition, The Safe Medical Device Act of 1990 was enacted.
• 1992 – Congress passes a new law creating a faster approval process to legalize new drugs. Approval times drop from 30 to 12 months. Sixty percent of new drugs come onto the market faster in the U.S. compared to other countries; whereas, before this law, the approval process was slower and more drugs were released in other countries first. The Medical Device Amendments of 1992 were revised and expanded the 1976 Act.
• 1997 – FDA loosens restrictions on consumer advertising. Drug companies are allowed to spend less time describing risks and side effects in commercials.
• 1998 – FDA announces the Pediatric Rule, a regulation that requires manufacturers of selected new and extant drug and biological products to conduct studies to assess their safety and efficacy in children.
• 1999 – ClinicalTrials.gov was founded.
• 2002 – The Best Pharmaceuticals for Children Act was enacted to improve safety and efficacy of patented and off-patent medicines for children.
• 2002 – In the wake of September 11, 2001, the Public Health Security and Bioterrorism Preparedness and Response Act was designed to improve the country's ability to prevent and respond to public health emergencies, and provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.
• 2004 – Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.
• 2005 – Formation of the Drug Safety Board, bringing together FDA staff and representatives from the National Institutes of Health and the Veterans Administration.
• 2006 – The FDA has entered into the global marketplace, the information revolution, and increased trade negotiations. The FDA evolved into the international arena in emerging public health issues and safety.
• 2010 – Affordable Care Act (ACA) was signed into U.S. Law. The impact to the FDA is requirement that manufacturers and authorized distributors must submit specific information concerning drug sample distribution. This includes 1) the identity and quantity of drug samples requested; 2) the identity and quantity of drug samples distributed; 3) the name, address, professional designation, and signature of any person who makes or signs for the request; and 4) any other category of information determined appropriate by the FDA Secretary.
• 2012 – The FDA was given the authority by the Food and Drug Administration Safety and Innovation Act (FDASIA) to collect user fees from industry over five years to fund reviews of innovator drugs, medical devices, generic drugs, and bio-similar biological products.
• 2013 – The Office of Medical Policy (OMP) under the FDA was created.
What is the basis of FDA authority?
How does the new 2012 FDA authority help consumers?
As explained above in 2012, the FDA was given authority by FDASIA to collect user fees to fund innovator drugs, etc. This process promotes innovation to speed patient access to safe and effective products, increases stakeholder involvement in FDA processes, and enhances the safety of the drug supply chain.
Just as important, FDASIA improves the agency's ability to help prevent drug shortages. Recently in 2015, the FDA issued a final rule requiring all manufacturers of certain medically important drug and biologic products to provide the FDA with early notification of potential drug shortages and to report potential reasons for that potential shortage. The FDA says the number of drug shortages has nearly tripled, jumping from 61 drug products in 2005 to 178 in 2010. These shortages do not include shortages of vaccines, immune globulin products, and other biologics, or products made from blood, tissue, or other biological source.
Innovation is being promoted under FDASIA through greater patient engagement, includinga five-yearPatient Focused Drug Development programto learn from patients about the impact of their disease on their daily lives. As this strategy makes clear, knowledge and understanding of a patient's perspective on disease are critical. But equally significant is the importance of ensuring adequate data quality and transparency in research to develop new treatments.
What are the different branches of the FDA?
5. Center for Veterinary Medicine (CVM).
Each center has its own origins and history, the oldest being CBER, which oversees blood products, vaccines, and newer therapeutics related to stem cells and gene therapy. The CDER receives the most scrutiny as this center regulates pharmaceutical medicines.
• Direct the development of policy, regulations, and guidances intended to communicate and implement consistent, standard policies and procedures related to medical policy for internal and external use.
• Establish and oversee working groups to accomplish specific assessments and projects.
• Review work products (e.g., documents and recommendations) of working groups before they are circulated for clearance.
• Promote and coordinate internal and/or external communication of medical policy decisions when appropriate.
• Develop agency-wide communications on medical policy decisions when appropriate.
Examples of MPC issues and challenge resolution work includes the development of an appropriate control regimen when a new product has already been adopted by the medical community as the standard of care for a new off-label indication; approaches to new indications proposed by industry sponsors; and/or standards of evidence for prophylaxis where efficacy and safety may not be testable in humans, such as prevention of anthrax.
Neither the FDA nor the Federal government regulates the practice of medicine. Any approved drug or product may be used by a licensed practitioner for uses other than those stated in the product label.
What is the FDA approval process for devices?
• Step One – The marketing process to make absolutely sure that the product to be marketed is a medical device, that it meets the definition of a medical device, and that the product is registered properly.
• Step Two – The determination by the FDA of the device classification. Unless exempt, the FDA will classify the product. The classification identifies the level of regulatory control that is necessary to assure safety and efficacy of the product. In addition, the classification will identify, unless exempt, the marketing process the manufacturer must complete in order to obtain FDA clearance and approval before marketing. This may include review of the manufacturer's Good Manufacturing Practices (GMPs), assuring quality systems in the manufacturing plants and enforcement of activities.
1. Class I – devices of least risk, under general control, such as band-aids, examination gloves, and hand-held surgical instruments.
2. Class II – devices presenting greater concern, under general and special control, subject to post market surveillance studies or adherence to performance standards, such as glucose monitors, wheel chairs, and infusion pumps.
3. Class III – devices, under general control and the Premarket Approval (PMA) process, which include many implanted and life-supporting or life-sustaining products that are subject to the most stringent controls and requirements. This includes a comprehensive premarket review, such as implantable pacemaker pulse generators and left ventricular assist devices.
• Step Three – The development of data and/or information necessary to submit a marketing application, through requisite design, engineering bench tests as needed, and data from animal and/or human clinical trials. Then the manufacturer may obtain FDA clearance to market.
What is the FDA approval process for drugs or biologicals?
• Stage One: Animals Tested – Drug manufacturer or sponsor applies to the FDA by submitting an Investigational New Drug (IND) Application. The FDA must be shown the results of pre-clinical testing and the proposals for human testing. The FDA determines whether it is safe to move forward with drug testing on humans.
• Stage Two: IND Application – Drug studies in humans can begin only after the IND is reviewed by the FDA and a local institutional review board (IRB). The IRB is responsible for approving the clinical trial protocols, to mandate the participants have given consent and are fully informed of the risks, and to direct researchers take appropriate steps to protect participants from harm.
• Stage Three: Phase 1 – Phase 1 studies, usually conducted in healthy participants, are done to determine what the drug's most frequent side effects are and how the drug is metabolized and excreted. Typically, the number of subjects range from 20 to 80.
• Stage Four: Phase 2 – Phase 2 studies start if Phase 1 studies don't reveal unacceptable toxicity. The emphasis of Phase 2 studies is on effectiveness, or whether the drug works in people who have a certain disease or condition. In controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment, e.g., placebo or a different drug. Additionally, there is continued evaluation of safety and short-term side effects. The number of subjects in Phase 2 studies typically ranges from a few dozen to about 300. At the end of Phase 2, the FDA and the sponsors meet to discuss how large-scale studies in Phase 3 will be done.
• Stage Five: Phase 3 – Phase 3 studies begin if evidence of effectiveness is shown in Phase 2 studies. These studies gather more information about safety and effectiveness, studying different populations and dosages, and using the drug in combination with other drugs. Usually the number of subjects range from several hundred to about 3,000 people.
• Stage Six: Review Meeting – The FDA meets with the drug sponsor in preparation for submission of a New Drug Application (NDA).
• Stage Seven: NDA Application - The formal step is for the drug sponsor to request the FDA's consideration in approving a new drug for marketing in the U.S., via a New Drug Application (NDA). The NDA includes all the animal and human testing data and analysis of data as well as information about the drug's behavior in the participant's body, and how the drug will be manufactured. A review team of physicians, chemists, statisticians, microbiologists, pharmacologists, and other experts evaluates the studies the sponsor submitted showing the drug is safe and effective for its proposed use. The FDA may call on an advisory committee of outside experts to review the NDA and make their recommendations. Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before the required measures of effectiveness are available.
• Stage Eight/Nine: Application Reviewed – After an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. The expectation of the FDA's CDER is to review and act on at least 90% of NDAs for standard drugs no later than 10 months after the applications are received. The review goal for priority drugs is six months.
• Stage Ten: Drug Labeling – The FDA reviews the drug's professional labeling and assures appropriate information is communicated to health care professionals and consumers.
• Stage Eleven: Facility Inspection – The FDA inspects the facilities where the drug will be manufactured.
• Stage Twelve: Drug Approval – FDA reviewers will approve the application or issue a response letter.
What is the 510(k) clearance process?
What is the Premarket Approval (PMA) process?
What is FDA de novo classification?
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a de novo classification request to the FDA for novel low to moderate risk devices without first being required to submit a 510(k).
There are two options for de novo classification for novel devices of low to moderate risk.
• Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a de novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
• Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a de novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.
Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.
What the special designations assigned for FDA approvals?
Humanitarian Device Exemption (HDE) – This exemption applies to devices that would otherwise be subject to the PMA process, but are intended to treat relatively rare diseases, affecting less than 4,000 patients per year. This process recognizes the fact that it may be difficult to recruit adequate numbers of patients to participate in clinical trials, and thus, the FDA requires the manufacturer to submit data regarding the safety of the device and the "probable" benefit.
Orphan Product Designation (OPD) – An Orphan Drug is defined in the 1984 amendments of the Orphan Drug Act as "a drug intended to treat a condition affecting fewer than 200,000 persons in the United States or will not recover development cost, plus a reasonable profit, within seven years following FDA approval. The Orphan Drug Act was signed into law on January 4, 1983."
Why would the FDA not approve a product claim?
• Abbreviated New Drug Application (ANDA) – A simplified submission permitted for a duplicate of an already approved drug. ANDAs are for products with the same or very closely related active ingredients, dosage form, strength, administration route, use, and labeling as a product that has already been shown to be safe and effective.
• Accelerated Approval – A highly specialized mechanism intended to speed approval of drugs promising significant benefit over existing therapy for serious or life-threatening illnesses.
• Active Ingredient – Any component that provides pharmaceutical activity or other direct effect in the diagnosis, treatment, cure, or prevention of disease or affect the structure or function of the body.
• Action Letter – An official communication from the FDA to NDA sponsor that informs of a decision by the agency.
• Advisory Committee – A panel of outside experts convened periodically to advise the FDA on safety and efficacy issues about FDA-regulated products. The FDA is not bound to take the committee's recommendations, but usually does.
• Approval Letter – An official communication from the FDA to NDA sponsor that allows for commercial marketing of the product.
• Bioequivalence – Scientific basis on which generic and brand-name drugs are compared.
• Brand Name Drug (BND) – A drug marketed under a proprietary, trademark-protected name.
• Clinical Studies – Human studies designed to distinguish a drug or device's effect from other influences.
• Cosmetic – Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance of the individual.
• Device – see Medical Device.
• Discontinued Drug – A drug product that has been removed from the market in the U.S. for reasons other than safety or efficacy.
• Drug – Articles intended to diagnose, treat, cure, or prevent disease and articles (other than food) as well as intended to affect the structure or any function of human or animal body.
• Drug Form/Product – The finished dosage form (tablet, capsule, etc.) that contains a drug substance.
• Drug Shortage – An inadequate supply of medically necessary drugs that are used to treat or prevent a serious disease or medical condition for which there is no alternative medicine available.
• Drug Substance – The active ingredient intended to diagnose, treat, cure, or prevent disease or affect the structure or function of the body, excluding other inactive substances used in the drug product.
• Effectiveness – The desired measure of a product's influence on a disease condition.
• FDA Action Date – Date when any FDA regulatory action was taken, such as an original or supplemental approval took place.
• FDA Application Number – This number, also known as NDA number, is assigned by the FDA staff to each application for approval to market a new drug in the U.S. One drug can have more than one application number if it has different forms or routes of administration.
• FDA Approval or Clearance – The product itself is approved or not approved, but the claim about the product has been granted a marketing license, a product label.
• Generic Drug – The same as a brand name drug in dosage, safety, strength, method of administration, quality, performance, and intended use.
• Good Clinical Practices (GCPs) – These are the regulations and requirements that must be complied with while conducting a clinical trial. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device.
• Good Manufacturing Practices (GMPs) – These are the regulations and requirements that domestic or foreign manufacturers must have to provide quality systems for the design, production, manufacture, packaging, labeling, storing, installation, and servicing of finished medical devices intended for commercial distribution in the U.S.
• Investigational Device Exemption (IDE) – This process allows for the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support and complete the marketing approval process.
• IDE Trials – These studies are frequently randomized controlled trials that may produce high quality data. Some IDE trials focus on the final health outcomes; others may focus on the outcomes selected for that trial or intermediate patient outcome.
• Investigational New Drug Application (IND) – An application that a drug sponsor must submit to the FDA before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including structural formula, animal test results, and manufacturing information.
• Label – The official description, approved by the FDA, of a product which includes the indication (what is it used for), who should use or take it, any adverse effects, instructions for use in pregnancy, children, and other populations, and safety information.
• Market Device Safety Alert – This alert is issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.
• Marketing Status – Indicates how a product is sold in the U.S., such as prescription, over-the-counter, discontinued, or none.
• Market Withdrawal – The product is withdrawn from the market when the product has a minor violation that would not be subject to FDA legal action. The manufacturer removes the product from the market, corrects the violation, and returns the product to the manufacturer.
• Medical Device – A product that is marketed as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other related articles, component parts, or accessories. Medical devices range from tongue depressors to complex programmable pacemakers.
• New Drug – A drug first investigated or proposed for marketing after 1938. Any drug manufactured before that date is not generally recognized as safe and effective.
• New Drug Application (NDA) – An application requesting FDA approval to market a new drug for human use in the interstate commerce. The application must contain, among other things, data from specific technical viewpoints for FDA review, including chemistry, pharmacology, medical, biopharmaceutics, statistics, and anti-infective microbiology.
• Over-The-Counter (OTC) – A product that is safe and effective for use by the general public without a physician's prescription.
• Pharmacology – The science that deals with the effect of drugs on a living organism.
• Post-Marketing Surveillance (PMS) – The FDA's ongoing safety monitoring of marketed products.
• Preclinical Studies – Studies that test a drug on animals and other nonhuman test systems. They must comply with the FDA's good laboratory practices. Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human studies (clinical studies). Also, because animals have a much shorter lifespan than humans, valuable information can be gained about a drug's possible toxic effects over an animal's life cycle and on offspring.
• Recall – Recalls are actions taken by a manufacturer to remove a product from the market. Recalls may be conducted on a manufacturer's own initiative, by FDA request, or by FDA order under statutory authority.
• Registration of Food Facilities – A new U.S. regulation, published October 10, 2003, in response to the Bioterrorism Act, which, among other requirements, ordered domestic and foreign facilities that manufacturer, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA by December 12, 2003.
• Safety – No drug or device is completely safe or without the potential for side effects or harm. For example, before a drug may be approved for marketing, the law requires the submission of results of adequate tests to show the drug is safe under the conditions of use in the proposed labeling. Thus, "safety" is determined case by case and reflects the drug's risk-versus-benefit relationship.
• Shortage – see Drug Shortage.
• Significant Risk Device (SRD) – An investigational device that presents a potential for serious risk to the health, safety, or welfare of a patient; however, it is still used to support or sustain human life and represents a potential for serious risk or used in the diagnosis, treatment, cure, or prevention of a disease.
• Transitional Device (TD) – A device the FDA had previously regulated as a new drug or an antibiotic drug before May 28, 1976.
• Treatment IND – A mechanism that allows promising investigational drugs to be used in "expanded access" protocols. These protocols are relatively unrestricted studies in which the intent is both to learn more about the drugs, especially their safety, and to provide treatment for people with immediate life-threatening or otherwise serious diseases for which there is no real alternative.
User Fees – Charges to drug firms for certain NDAs, drug products, and manufacturing establishments. The FDA uses these fees to hire more application reviewers and to accelerate reviews through the use of computer technology.
In instances considered to be experimental, investigational and/or unproven.
1. FDA.gov – Statement on Medical Devices by Michael Friedman, M.D. April 30, 1997. U.S. Food and Drug Administration. <http://www.fda.gov>.
2. FDA.gov – Swann, J.P. History of the FDA. 1998. U.S. Food and Drug Administration. <http://www.fda.gov>.
3. FDA.gov – Statement on Medical Devices by Elizabeth D. Jacobson, Ph.D. March 25, 1999. U.S. Food and Drug Administration. <http://www.fda.gov>.
4. FDA.gov – Recalls: Background and Definitions. February 13, 2002. U.S. Food and Drug Administration. <http://www.fda.gov>.
5. FDA.gov – Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). July 8, 2002. U.S. Food and Drug Administration. <http://www.fda.gov>.
6. FDA.gov – Meadows, M. The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective – FDA Consumer Magazine. September 10, 2002. U.S. Food and Drug Administration. <http://www.fda.gov>.
7. FDA.gov – Getting To Market with a Medical Device – Device Advice. October 1, 2002. U.S. Food and Drug Administration. <http://www.fda.gov>.
8. FDA.gov – Is the Product a Medical Device – Device Advice. October 1, 2002. U.S. Food and Drug Administration. <http://www.fda.gov>.
9. FDA.gov – Device Class – Device Advice. November 21, 2002. U.S. Food and Drug Administration. <http://www.fda.gov>.
10. FDA.gov – Drug Approval Application Process – Center for Drug Evaluation and Research. May 14, 2003. U.S. Food and Drug Administration. <http://www.fda.gov>.
11. FDA.gov – Review Process – Device Advice. June 11, 2003. U.S. Food and Drug Administration. <http://www.fda.gov>.
12. FDA.gov – Introduction: IDE Overview – Device Advice. July 8, 2003. U.S. Food and Drug Administration. <http://www.fda.gov>.
13. FDA.gov – Good Manufacturing Practices (GMP)/Quality System (QS) Regulation– Device Advice. January 28, 2004. U.S. Food and Drug Administration. <http://www.fda.gov>.
14. FDA.gov – Classify Your Medical Device – Device Advice. August 8, 2004. U.S. Food and Drug Administration. <http://www.fda.gov>.
15. FDA.gov – Drugs @ FDA – Glossary of Terms. September 10, 2004. U.S. Food and Drug Administration. <http://www.fda.gov>.
16. Overview of FDA Medical Device Approval Process. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Medical Policy Clearinghouse News (2004 August 27) Archives.
17. FDA.gov – Orphan Product Designation. September 27, 2005. U.S. Food and Drug Administration. <http://www.fda.gov>.
18. FDA.gov – Significant Dates in U.S. Food and Drug Law History. November 6, 2012. U.S. Food and Drug Administration. <http://www.fda.gov>.
19. FDA.gov – FDA Basics. March 6, 2014. U.S. Food and Drug Administration. <http://www.fda.gov>.
20. FDA.gov – Affordable Care Act (ACA 6004). August 22, 2015. U.S. Food and Drug Administration. <http://www.fda.gov>.
21. FDA.gov – Food and Drug Administration Safety and Innovation Act (FDASIA). August 22, 2015. U.S. Food and Drug Administration. <http://www.fda.gov>.
22. FDA.gov – Office of Medical Policy. August 22, 2015. U.S. Food and Drug Administration. <http://www.fda.gov.
23. FDA.gov –The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective. November 6, 2014. U.S. Food and Drug Administration. <http://www.fda.gov>.
24. FDA.gov –Evaluation of Automatic Class III Designation (De Novo) Summaries. June 5, 2017. U.S. Food and Drug Administration <http://www.fda.gov>.
11/1/2015 Document updated with literature review. Coverage unchanged.
3/15/2013 Document updated with literature review. Coverage unchanged.
6/15/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.


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You are here: Home / Archives for Stephanie Spyropoulos, Express Correspondent
Salute to nation's fallen
May 29, 2019 By Stephanie Spyropoulos, Express Correspondent
There have been 1.1 million U.S. military personnel killed in all American wars, including the ongoing Global War on Terror. Residents of Whitman and Hanson joined the nation in honoring those who gave that last full measure of devotion during parades and ceremonies Monday, May 27.
Whitman Girl Scouts carried posters bearing photos of that community's war dead in the parade and, in Hanson, state Rep. Josh Cutler, D-Duxbury, honored one of Hanson's fallen during post-parade ceremonies at Fern Hill Cemetery.
"I'm standing here in what is known as the Unreturned Lot, which commemorates the lives of the 26 or 27 — we're not exactly sure — Hanson men who were killed during the Civil War," Cutler said, noting the 1.1 million who have fallen in all U.S. wars, such a huge number it almost becomes a statistic. "It's hard to fathom that kind of loss. Memorial Day is an opportunity to narrow the gap between tragedy and statistic."
Cutler did so by focusing on the loss of Tech. Sgt. Elmer R. Hammond, killed in action at the age of 21, in a B-17 on his 40th mission in the skies over WWII Europe.
He joined the U.S. Army in 1943 after the Navy and Marine Corps had turned him away because he was not an American citizen, Cutler related. Born in Nova Scotia in 1923, Hammond moved to Hanson with his family when he was 6. The Hanson American Legion Post bears his name.
"Tech. Sgt. Hammond was the first WWII soldier casualty from Hanson [and] he was laid to rest right here in Fern Hill Cemetery," Cutler said. At the time of Elmer Hammond's death, his younger brothers Sam and Gilbert were 9 and 7 years old.
"Sam later recalled that, 'Elmer was a great guy who was brave, heroic and a guy I'd like to have as my back-up,'" Cutler said. "Sgt. Hammond is just one of the many heroes our town, our Commonwealth, and our nation have lost in war time. Today, I urge you to keep the memories of these men and women alive."
Whitman's Memorial Day Observances kicked off with morning wreath laying ceremonies in celebration of the 151st year honoring those who have honored their country at the cost of their lives.
Selectman Dan Salvucci addressed parade goers, citing one of his favorite local events honoring Memorial Day.
"We remember: an event at Duval School where the kids commit to memory their relatives who have passed away and have given their all to serve to keep our country safe," he said.
He thanked all who carried flags to honor those who passed. He shared a small narrative about honoring his late father in- law, a veteran, by carrying a flag in the parade something that he keeps close to his heart.
State Rep. Alyson Sullivan, R-Abington, thanked Pack 22 whose members had placed countless flags in honor of those fallen but not forgotten around multiple locations in Whitman.
She spoke of the sacred motivations behind celebrating Memorial Day and honoring those who have given their lives and also those who have returned as veterans some who suffer in silence with PSTD.
"Each and every war from the birth of our nation to our wars in Iraq and Afghanistan has come at great cost," Sullivan said. "As we do each year on this special day of reflection we gather, we pause we pray, we remember the heroes who served and made the ultimate sacrifice so that we can enjoy these treasured gifts. … Today it's our duty to and the duty of our grateful nation to remember and honor those who served and sacrificed."
Three of Pack 22 scouts wrapped up the Town Hall services with a reading of prayer, moving on to lay wreaths in the WW I Memorial Arch, Colebrook Cemetery, the Town Park flag pole, Civil War Soldiers Monument and Veterans Monument all Wars -among the early morning honors several other memorials were paid tribute. The warm weather brought crowds in droves as they lined the South Avenue in front of the Town Hall and Post office.
"I really appreciate all the community support," Hanson Veterans Agent Timothy White said during ceremonies at Indian Head School before the town's parade stepped off. "It's very much appreciated."
School Committee Chairman Bob Hayes handed a folded American flag to Scouts who raised it on the school's flagpole to full-staff, before lowering it to half-staff for the observance before Hanson Middle School student Noah Roberts read Gov. Charlie Baker's Memorial Day Proclamation.
Janet Hamilton, a U.S. Sanitary Commission re-enactor with the U.S. 22nd Vols., out of Rockland, was escorted by Selectman Jim Hickey in placing a wreath at the war memorial at the school. Hamilton, of Taunton, was dressed in Civil War-era mourning dress and veil to represent all widows of war dead. She was escorted by Selectmen Kenny Mitchell and Wes Blauss for a wreath laying at the town's Civil War monument on Town Hall Green and by Selectmen Laura FitzGerald-Kemmet and Matt Dyer at the Unreturned Memorial at Fern Hill Cemetery.
The Mass. 22nd Vols. Fired a ceremonial rifle salute at each wreath-laying ceremony and members of the Hanson Middle School band played "Taps."
"Let peace prevail among all the nations," the Rev. Peter Smith of Hanson Congregational Church said in his prayer opening the day's events.
Roberts recited the Gettysburg Address at Fern Hill and the Rev. Michael Hobson of St. Joseph the Worker Church closed with a prayer for blessings on the fallen and for their families' peace of heart and mind.
Filed Under: More News Left, News
Donnie's on the road again
WHITMAN — Not long ago, if you had asked Donnie Westhaver of Whitman what he would be doing in two years, driving a motorcycle would probably not be what you would have expected to hear.
Westhaver has been confined to a wheelchair after suffering devastating complications from spinal fusion surgery just two years ago. He now lives as a quadriplegic only recently gaining hand and arm strength with braces and grueling, twice weekly physical therapy.
Living in a wheelchair and the life altering circumstances does not define him, however. He has made his life mission and purpose about serving and helping others.
He admits that he struggles with having to rely on helpers to transport him to appointments although he has a handicap assessable van he is unable to operate it independently, yet. One day he hopes to have the arm strength to operate independently. For now he gratefully relies on friends and family to take him out, he said.
Recently he began researching the Marine Mobility Conquest Trike, a handicapped assessable customizable trike that allows a wheel chair to fit compatibly and stably on a platform inside a motorized compartment. It was a limited product no longer being manufactured and Westhaver thought the chances were slim that he would cross paths with the bike.
But, as fate would have it, he received a call from his cousin in Texas who had seen the exact trike on EBAY. They tracked it down made a bid and the rest is history.
He has received encouragement from his family to gain some independence and a sense of freedom again.
The last few years have been emotional after losing his wife Susan from lung cancer. They were married for over 40 years. Having so many changes in a short period of time has not been easy, he said.
He sold his trailer and boat to free up funds for the trike.
"My family agreed that it was best to sell them now in order to be able to use something that would give me mobility to get around," said Westhaver.
His attitude is infectious and giving back to the community re-energizes him. He has co-organized the Whitman Area Toy Drive for over a decade providing hundreds of families in need with toys, gift cards and food during the holiday. He also served as president of the VFW men's auxiliary and is a past commander of the Whitman Sons of the American Legion. He helps and stays involved with other groups as well. He is the retired superintendent of the Whitman DPW, and a founder of Whitman Wheels for disabled Veterans and Citizens which provides medical mobility equipment to those that cannot afford the items due to lack of insurance or monetary reasons.
When the trike arrived it was comparable to Christmas morning.
The most incredible part of the mobility trike when it arrived was the 3-D artwork from front to back, he said.
"Seeing the photos online really did not do it justice," said Westhaver.
As he poured over the artwork he wondered more about the drawings and what they meant. He reached out to the artist John Steven St. Clair of Florida the former owner of Metal Mafia Custom Painting in Orlando. He spoke several times with Westhaver explaining why the photos depicted on the moving mural meant so much to his customer and friend Mike. (Since the Express could not reach out to his family they are identifying him only by his first name.)
St. Clair relayed the stories of each piece of art to Westhaver. One of the most impressionable sections of the trike is a row of four faces all Mike's fallen military comrades — tributes to Pfc. Jay S. Cajimat, Sgt. Andrew R. Looney, Cpl. Durrell Bennett and Sgt. William Wayne Crow whose deaths were all related to their services oversees following 9-11 said St. Clair as he was told.
Westhaver has poured over the surface, which are emblazoned with emotional depictions undoubtedly a mix of memories and nightmares as Mike suffered from severe PTSD and took his own life several years ago.
On the day he spoke with the Express, Westhaver's registration plate arrived via Gail Varraso of O'Rourke's Insurance in Whitman. She was as happy as Westhaver who beamed from ear to ear as he held the numbered tag that would allow him a taste of the open road riding Mike's trike. The freedom allotted to Westhaver has somehow been restored even in the smallest of amounts as he prepares to drive again.
Filed Under: More News Right, News
Multiple fires keep WFD crews busy
March 28, 2019 By Stephanie Spyropoulos, Express Correspondent
Whitman Fire Chief Timothy Grenno, third from left, and Hanson Fire Chief Jerome Thompson Jr., third from right, talk with firefighters and residents of 81 School St., March 21. (Photo by Stephanie Spyropoulos)
WHITMAN — The last several weeks have been exceptionally busy for first responders in Whitman, Fire Chief Timothy Grenno said Tuesday. Amid day-to-day medical calls, the department has responded to four separate house fires since Feb. 13.
One of the fires occurred at 4:30 a.m., Tuesday, March 26, only hours after firefighters returned from an extensive brush fire on the Whitman Abington town line.
Early Tuesday morning the Whitman Fire Department responded to a report of a house fire at 142 Raynor Ave.
A passerby noticed the fire and called 911 also waking the family inside and helping them safely get out of the house. There were no reported injuries, according to a statement through Grenno's office.
When firefighters arrived, the single-family ranch-style home had fire showing from an outside wall of an attached garage. The fire had extended up the exterior wall and the interior walls of the garage. Abington fire department responded to the scene to provide assistance.
The fire was quickly brought under control and firefighters successfully prevented the flames from spreading further into the house.
The initial investigation indicates that the fire started accidentally due to the spontaneous combustion of oily rags that were used earlier in the day to strip a floor.
"I would like to commend the passerby for their quick actions in calling 911 and having the wherewithal to wake up the family and get them out of the house," Chief Grenno said. "Anyone dealing with oily rags or cloths should never leave them in a pile and should hang them up to dry or lay them out on the ground. As the rags dry, they give off heat and if the heat is not released it can cause a fire."
At about 2:30 p.m., Monday March 25, Whitman Fire Department helped in extinguishing a large brush fire that started in Abington on Brockton Avenue .
"Upon arrival, firefighters discovered that the fire had spread toward the high tension power lines on the Whitman/Brockton town lines. The large swath of land sits near the town lines of the three communities. 'Whitman deployed a brush truck, engine and shift commander to help coordinate extinguishing the flames'" Grenno said.
Firefighters from Abington, Brockton and Holbrook responded and were relocated to keep ahead of the flames.
It took firefighters about two hours to fully extinguish the fire, which burned about four acres of land. Firefighters successfully prevented the fire from spreading to any nearby buildings. No injuries were reported and the cause of the fire is under investigation, but is not considered suspicious at this time.
School Street
On March 21, a family was displaced at 81 School St., following a kitchen fire.
Later determined to be a grease firefirefighters from Whitman Hanson, East Bridgewater and Abington assisted in controlling and extinguishing the heavy fire and were able to prevent further spreading into the remaining multi family home.
No injuries were reported and four residents of the building were temporarily displaced due to fire, smoke and water damage to the home.
Initial investigation indicated that the fire was caused by grease in a cooking pan. The resident attempted to put the fire out with flour, but was unsuccessful.
The damage done to the home was estimated at about $60,000.
Chief Grenno commended the work of firefighters for their quick response and knockdown of the fire.
"Thankfully our ambulance had just returned from a hospital transport with two of our six on-duty firefighters on board," Chief Grenno said. "Had the fire started 10 minutes earlier we would have only been able to send four firefighters and there would have likely been significantly more damage to the house. This incident, along with two other significant fires in recent months, highlights the importance of a properly staffed fire department."
Firefighters responded to 134 Bayberry Road Feb. 23 for a reported chimney fire just after 9:30 p.m.
While en route, firefighters were notified that flames had extended into the one and a half story building. A fire in a wood stove had extended to the chimney, exterior wall and ceiling.
The location of the fire presented firefighters with unique challenges, requiring them to do extensive work opening up of the home's ceiling and wall in order to fully extinguish the flames.
"Our firefighters did an excellent job extinguishing a fire under complex circumstances," Chief Grenno said.
There were no injuries as a result of the fire, and the home's lone occupant spent the night with a family member.
Whitman firefighters were supported on scene by crews from the Abington, East Bridgewater and Hanson fire departments.
The cause of the fire remains under investigation. The damage to the home was estimated at $40,000.
The largest fire, which reached six alarms for man power and EMS occurred to a three story apartment complex in the early evening on Commercial Street Feb. 13 in Whitman.
The house has since been razed.
Police: Social media ploy lured youth
Matthew Murphy. (Photo courtesy United States Marshals Service)
WHITMAN — A Whitman man has been arrested and is facing allegations that he sexually exploited children after he created a fake social media account.
Matthew Murphy, 22, of Temple Street in Whitman, was charged in federal court on Tuesday on two counts of sexual exploitation of children.
Murphy posed as a teen girl using a Snapchat account to extort nude photographs from a Massachusetts middle school boy. The investigation of the alleged incidents was detailed in the charging documents, according to a press release from the United States Attorney Andrew E. Lelling and Peter C. Fitzhugh, Special Agent in charge.
Federal agents obtained portions of the Snapchat account Murphy had created in the fake identity and uncovered evidence of similar extortion of other minors in the area, according to the press release.
Murphy was detained pending a detention hearing scheduled for Wednesday at 3:30 p.m.,
Agents and Whitman police executed a search warrant of Murphy's home where he was placed under arrest.
"It is a reminder that these predators are out there," said Whitman Police Chief Scott Benton. "They want to prey on and take advantage of the innocence of children."
Law enforcement is actively working to identify additional victims. Members of the public with questions or information about this matter should call 617-748-3274 or Whitman police at 781-447-1212.
"During the execution of the search warrant at his home, Murphy admitted that the fake account was his, and investigators found forensic evidence of the account on some of his electronic devices. Murphy was subsequently arrested," according to the press release.
The charges of sexual exploitation of children each provide for a minimum mandatory sentence of 15 years and no greater than 30 years in prison, a minimum of five years and up to a lifetime of supervised release and a fine of $250,000. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.
United States Attorney Andrew E. Lelling and Peter C. Fitzhugh, Special Agent in Charge of Homeland Security Investigations in Boston, made the announcement Wednesday. The Whitman Police Department provided valuable assistance with the investigation. Assistant U.S. Attorney Anne Paruti, Lelling's Project Safe Childhood Coordinator and a member of his Major Crimes Unit, is prosecuting the case.
The case was brought as part of Project Safe Childhood. In 2006, the Department of Justice created Project Safe Childhood, a nationwide initiative designed to protect children from exploitation and abuse. Led by the U.S. Attorneys' Offices and the DOJ's Child Exploitation and Obscenity Section, Project Safe Childhood marshals federal, state, and local resources to locate, apprehend, and prosecute individuals who exploit children, as well as identify and rescue victims. For more information about Project Safe Childhood, visit projectsafechildhood.gov/.
Filed Under: Breaking News, News
Compassion on the beat
A rainy window reflects a police officer on the job. Mental health clinician ride-alongs on Fridays now provide assistance to officers responding to health-related crises. (Photo by Stephanie Spyropoulos)
WHITMAN — The Whitman Police Department is taking advantage of a local grant, which has afforded several South Shore communities the services of a mental health clinician to ride along with a dispatched officer.
The program was launched in January 2019.
Katrina Lee, jail diversion coordinator for High Point Middleborough outpatient clinic, rides with a Whitman supervising officer on Friday nights, allowing for immediate assistance in cases of domestic violence, substance abuse and other mental health-related crises.
The Commonwealth of Massachusetts Department of Mental Health funded the mission titled: a Regional Co Response Jail/Arrest Diversion Project (RJDP) with $45,000 in conjunction with High Point contracted services approved in 2018.
Whitman Police Chief Scott Benton said the proactive approach is similar to one departments have implemented in the past years to assist with opioid addiction, treating respective mental illnesses rather than waiting until the problem escalates. He said the shifting mindset is being applied and supported through the new program.
Benton referred to the awareness as a step in the right direction as officers are better equipped with the knowledge of an underlying mental illness.
"It is getting everyone in the room: police, fire and hospitals to help these people. If the people get help, then get out of a facility and they don't have other services it becomes a merry-go round for them," said Benton.
There are times when a resident refuses intervention.
"They can decline but Lee can point them in the right direction for services," said Benton. "We are getting into the game. We are way behind in treating mental health."
Feedback has been positive from the officers, he said.
"It's in the delivery," Benton said. "We want to make sure we are implementing something and give it a chance to succeed. Invariably things come up … we have issues to address – we do it together in partnership. Department heads and supervisors of police and fire met to address concerns at the beginning of the program.
"Paperwork and other expectations needed to be communicated to properly get the program a jump start in the community as with any new program," he said.
According to the studies and content in the grant request, some common disorders that are seen most frequently when a law enforcement officer is requested are: depression, anxiety, mood disorders; substance abuse is often an underlying issue or compounding component, self-harm and domestic violence.
A statistic used to support the grant request through the National Alliance on Mental Health NAMI"
"In a mental health crisis, people are more likely to encounter police that get medical help. As a result, two million people with mental illness are booked into jail each year," according to a statistic used to support the grant request through the National Alliance on Mental Health- NAMI.
Lee, as the clinician who is seeing firsthand how the program is evolving has expressed her commitment.
"I am excited to be a part of this program," said Lee.
She has worked with victims of crime alongside the DA's Office for the majority of her career. She is able to utilize her knowledge along with her clinical skills responding first hand to help people in the six communities.
"It is the perfect blend of my experiences. I'm hopeful that my background has proven helpful to the people I've spoken with to date," Lee said. "I really feel fortunate to be working with these departments because everyone from the chiefs to the officers I work with, are incredibly compassionate and genuinely want to help the members of their communities."
"As a group we want to see people with mental illnesses referred to appropriate agencies to receive support rather than having them brought through the criminal justice system if that can be avoided," Lee said. "In cases where it can't I am able to make referrals to the Mental Health Court, which can better address the mental health needs of the individual."
The grant guidelines stated that, "The co-response diversion model provides an opportunity to apply immediate, community based clinical services when and where they are needed in partnership with police officers responding to behavioral health calls. A consistent clinical presence in a police station has shown to have an overall beneficial effect on law enforcement personnel's attitudes towards individuals with behavioral health conditions and on vicarious skill building and knowledge. … The overall goal of our RJDP is to steer people with mental health difficulties away from the criminal justice system and into services that lead to mental health recovery as stated in the grant outline and project approval."
The approved grant was awarded to Bridgewater Police Chief Christopher Delmonte and includes, East and West Bridgewater — including Bridgewater State University police —and Middleboro police.
Whitman aids fire victims
February 20, 2019 By Stephanie Spyropoulos, Express Correspondent
WHITMAN — The night of the fire heavy black smoke could be seen from Route 58 in Hanson — the sounds of sirens rang from all directions — as fire apparatus from all over the South Shore helped battle a raging house fire at 316-18 Commercial St., on Wednesday, Feb. 13.
Word spread quickly that the three-story wooden structure was crumbling to the ground, siding melted down to the foundation along with it — destroying personal processions and mementos of approximately a dozen residents.
Remarkably no one was injured in the fire, reported by a resident through 911 just before 8 p.m. The blaze drew 80 firefighters and 15 departments from around the south shore.
"Upon arrival heavy flames were coming from a second-story window. The fire was spreading to the third floor and simultaneously burning the wooden deck outside of the window," said Whitman Fire Chief Timothy J. Grenno.
Deputy Chief Joe Feeney immediately struck a second alarm — a call for more assistance to the scene — due to the building structure and size. Chief Grenno called for additional mutual aid from other towns, striking a fifth alarm at approximately 9:25 p.m.
Hundreds of onlookers and media flooded the street filming the flames as they seem to propel from every gap of the structure. Residents lined the doorways and lawns dressed in pajamas, some wore white face masks as they shook their heads to evade the gusts of smoke, that mixed with snowflakes as the night progressed.
They Lost everything
"People have been amazing," said resident Hannah Fabian who has spent most of the last week in a daze filling out paperwork and trying to piece her life back together. Along with several other families in the building they have seen a vast amount of support as they start to rebuild.
Fabian, who was home when the fire started, had rented in the Whitman apartment building for less than six months with her boyfriend and two sons. Her cousin, David, and his daughter who is 11 and a middle school student in Whitman, rented an apartment on the lower level. Fabian had asked him to check her apartment when the boys, who were getting ready to visit their father, smelled burning plastic – within seconds smoke billowed from her bathroom. They all ran out of the building while the smoke alarms blared and called the fire department.
"When we got out of the house it was already completely covered in smoke. It went up in what seemed liked seconds," said Fabian. "I tried to stay calm for the kids but I couldn't help it we all were crying."
She left the fire scene after her sons, who are ages 8 and 11, were picked up by their father. She wore a red hoodie over her face and had a friend, who like her also has severe asthma, give Fabian an inhaler as her own medicine was left behind in the burning building.
David was trying to gather his tools outside the building as he sprayed a fire extinguisher, she said.
Fabian has received monetary help through a GoFundMe account a friend has created, but there are things that can't ever be replaced like baby books and photo albums, she said.
Battling the blaze
Firefighters battled the blaze and successfully prevented it from spreading to nearby homes. The heaviest flames were knocked down by approximately 9:30 p.m., said Grenno.
Several neighbors who viewed the intensity of the scene from parallel driveways used cell phones to document the fire, as they trained a watchful eye on their own homes.
Residents displaced by the fire were assisted by the American Red Cross — who responded to the scene.
The building, a total loss has since been demolished. Early estimates of the loss have totaled upwards of $1 million dollars in loss, according to Grenno.
The preliminary investigation indicated that the fire started in a second floor apartment. The cause of the fire is under investigation by Whitman Fire and investigators from the Massachusetts Department of Fire Services (DFS).
They were continuing their investigation Thursday Feb. 14, but at this time it does not appear to be suspicious. Grenno said that he did not know when the last fire inspection was done at the building, but that it had previously been up to code.
"This fire spread extremely fast and I want to commend our firefighters and those from our surrounding communities who responded to help put this fire out as quickly as they did," Grenno said. "We are thankful that no one was hurt and that all residents were quickly able to be accounted for."
As of Tuesday Feb. 19 the cause of the fire was still under investigation.
Crews worked to overhaul the house and extinguish hot spots until approximately 12:30 a.m. Thursday Feb. 14. The scene was cleared later in the day and an engine from Whitman remained on fire watch over night.
Firefighters from the following communities responded to assist on the call: Hanson, Abington, East Bridgewater, West Bridgewater, Bridgewater, Rockland, Brockton, Norwell, Hanover, Halifax, Hingham, Holbrook, Randolph, Marshfield, Avon and Pembroke.
In addition, the Whitman Police Department, Whitman Community Emergency Response Team (CERT), DFS Rehabilitation Unit and Boston Sparks Association A-10 also responded to the scene.
Austin Gould, a first grader at Conley School in Whitman, heard about the fire on Wednesday and when he arrived at school on Thursday he asked if he could talk to his school Principal Karen Downey.
"He came in to see me and said 'Well did you know there was a big fire?' My heart melted …" said Downey.
Gould explained that he remembered Downey telling them that they can help make a difference in other kids' lives and that was his goal. He wanted to help the kids who lost everything in the fire.
Downey has always stood by the lessons of education for her students however she also wants them to become good citizens, she said.
Her reaction upon hearing his objective to benefit the victims was one of pride
"Wow! They are hearing me," she said. "I was so impressed with the willingness and earnestness from such a wonderful little guy. Knowing they are absorbing all the lessons that are being taught by word and example is spreading pride through the Whitman schools."
Also students at Conley School, James and Charlotte Kleinman planned a lemonade stand to raise funds.
Five-alarm fire destroys Whitman house
Fire crews train their hoses on flames bursting through the roof of a multi-family house at 316-18 Commercial St., in Whitman Wednesday night. No one was injured as some 80 firefighters from 15 South Shore departments responded to the fire. (Photo by Stephanie Spyropoulos)
WHITMAN — Nearly 80 firefighters from Whitman and more than 15 South Shore communities battled a five-alarm blaze that destroyed a multi-family house at 316-18 Commercial St., Wednesday night.
No injuries were reported in the fire.
The building was a total loss, and including personal possessions, Whitman Fire Chief Timothy Grenno estimated that the damage could add up to nearly $1 million.
All of the nearly a dozen residents of the apartment building were displaced as a result of the fire. The American Red Cross responded to the scene to assist residents in finding shelter for the night.
A preliminary investigation points to the fire starting in a second floor apartment, but the exact cause of the fire is still under investigation by Whitman Fire and investigators from the Massachusetts Department of Fire Services (DFS). They were expected continue their investigation later Thursday morning, but at this time officials said it does not appear to be suspicious. Grenno said that he did not know when the last fire inspection was done at the building, but that it had previously been up to code, according to a statement. He stated that he did not know when the last fire inspection was done at the building.
"This fire spread extremely fast and I want to commend our firefighters and those from our surrounding communities who responded to help put this fire out as quickly as they did," Chief Grenno said.
Whitman Fire Chief Timothy Grenno watches Thursday afternoon as equipment from Watson Excavating of East Bridgewater is used to raze the multi-family home at 316-18 Commercial St., Whitman that was destroyed in Wednesday night's five-alarm blaze.
Residents told reporters on the scene that the power went out and they heard a popping sound before the flames broke out.
Whitman Fire/Rescue received a 911 call reporting a fire at an apartment building at about 7:45 p.m. Upon arrival crews found that heavy flames were coming from a second-story window. The fire was spreading to the third floor and simultaneously burning the wooden deck outside of the window.
Deputy Fire Chief Joe Feeney immediately struck a second alarm. Because of the size of the building and its wood-frame structure, the fire quickly spread through the house and Grenno called for additional mutual aid from other towns, striking a fifth alarm at approximately 9:25 p.m. Firefighters from Hanson, Abington, East Bridgewater, West Bridgewater, Bridgewater, Rockland, Brockton, Norwell, Hanover, Halifax, Hingham, Holbrook, Randolph, Marshfield, Avon and Pembroke responded to mutual aid calls. The Whitman Police Department, Whitman Community Emergency Response Team (CERT), DFS Rehabilitation Unit and Boston Sparks Association A-10 also responded to the scene.
Firefighters battle fire, weather in Hanson
HANSON — No injuries were reported Tuesday night as Hanson firefighters and those from three other towns battled stubborn flames in cold sleet and drizzle, making for a long night.
The call for the structure fire was received just after 7:30 p.m. with firefighters encountering heavy fire throughout the structure, according to Hanson Fire Chief Jerome Thompson.
Two occupants and a dog were able to flee the fire at 45 Milford St., according to published reports.
Upon arrival all occupants had exited the house, said Thompson.
The home was listed on several real estate websites Tuesday night as foreclosed, on, but the updated property sites now report the home as off the market. Neighbors who watched the mammoth flames take over the structure at the scene said they did not believe anyone was living in the home.
The jumbled debris on the interior made the conditions for firefighters challenging.
"Excessive clutter in the house made it difficult for firefighters to continue an aggressive interior attack and contributed to a lengthy overhaul process," said Thompson. the fire is under investigation.
Fire, smoke and water damage was extensive throughout the house, which is uninhabitable. The cause of the fire is currently under investigation by the Hanson Fire Department, Hanson Police Department and the Massachusetts State Fire Marshal's Office. The occupants are being assisted by the Red Cross.
Firefighters were assisted at the scene by Halifax, Pembroke and Whitman fire departments. Hanover Fire covered Hanson Headquarters and Pembroke Fire responded with an ambulance to a medical emergency in another part of town during the incident. Also assisting at the scene was Hanson Police, Hanson Highway and Water departments. All crews cleared the scene shortly after midnight.
W-H families hear mental health talk
February 7, 2019 By Stephanie Spyropoulos, Express Correspondent
Kristina Rowshan is a fighter.
The psychologist, originally from Philadelphia, is a recent college graduate, a daughter, a sister, and a survivor. She did not battle cancer — she battled her own mind and even though she still contests her thoughts daily. Rowshan is New England Outreach Coordinator for Spanish-Speaking Communities with Minding Your Mind, a mental health education collaborative.
She spoke candidly about her mental health struggles to guests at Minding Your Mind, a program Whitman Hanson Regional High School on Jan. 30 hosted by school counselors and guidance department.
The Minding Your Mind was a free event for the families in surrounding communities.
"I felt that Kristina was an amazing presenter in sharing her story and made such good connections with the families in attendance. I would bring her back in a heartbeat," said Kaitlyn Robichaud, an adjustment counselor at Whitman-Hanson within the Bridges for Reslilient Youth in Transition (BRYT) network and student support services.
She is also planning to have three major events for families to come and be able to learn something and gain support not just from the school but from each other.
For future information on guest speakers and family support programs upcoming calendar announcements are posted on W-H social media and the W-H school page.
Minding Your Mind offers self-empowerment to individuals who are taking control while working on their own treatment; connecting with others who need to hear and understand that there is hope. Her goal along with the organization is to encourage a reduction in the stigma around mental health and to increase the help seeking behaviors that often accompany improved coping skills.
Her recovery has been a long walk marked by small moments that have added up to great progress. While she continues to heal from her own self-destructive behavior, Rowshan proudly noted she is three years free of self-harming behavior.
Rowshan's mind was obsessive as far back as grade school.
Paralyzed for hours about returning home, feeling completely unable to enter her house she would wait in the driveway until she felt at ease about going inside. Obsessive thoughts would set off crying spells with fears of her home or bedroom being dirty, contaminated, or imperfect followed by inability to repair or clean the area with the ruminating thoughts taking over.
She would not completely feel relief but would eventually be coaxed in the door by family members, she said.
Her attempts at receiving help appeared to backfire, as the adults in her life did not know how to provide help and silently denied her crisis until she attempted to take her own life.
Still, she said it was never her intention to die.
"I didn't want to die, I told those around me," she said.
She desired expressive actions that would allow others to see the kind of pain she was in. Her daily struggles against her own frame of mind — and her battle to live a normal day. She wanted to ease her pain ever though she could not always explain it.
A perfect straight-A student and a varsity sport athlete during her early teens she walked around school with 'a cool kid smile' concealing her mental anguish.
She received a compliment from a fellow student who gushed that she idolized her and wanted to be just like her. The complimentary comments crushed Rowshan, as she realized the personal façade was now shattered.
She attempted her first suicide that next day.
Her mask of cheer and joy soon gave way to unforgiving self-harm, cries for help that she said went unanswered for years and through several steps of her treatments.
To her surprise, as she starved herself to death, blacking out from fatigue and malnourishment she had a mental health practitioner congratulate her on her excessive weight loss rather than question the red flagged behaviors.
An eating disorder she knew was so severe yet her deprivation and weight loss were unachievable strives for perfection. She was in a vicious circle of self-harm, which she explained was a coping mechanism to gain control instead she attempted suicide again at age 20.
She was placed in a long-term clinic for eating disorders and her life slowly turned around as she had only loose connections with clinicians, patients and staff that soon gave her a realization of importance.
Sharing her ultimate achievement she recently graduated from college. Not an easy feat for someone who changed schools multiple times and continuously battles depression, anxiety and severe obsessive compulsive disorder.
Her treatment in working with Dr. Reid Wilson, a specialist and pioneer in the treatment of OCD, has been an enormous step in the right direction, Rowshan said.
Challenging her own thoughts, talking back to her OCD can be freeing, according to Rowshan. She laughed with the audience about some of her positive coping mechanisms such as hitting her pillows with a racket and yelling out loud that although seemed slightly twisted — for her, they have proved extremely helpful.
Within her family, genetics and personal beliefs, once stopped them from reaching out for assistance but they are finally able to seek support. The family continues to see a counselor and works on recovering together as well as creating healthy boundaries, and conversations.
"Everyone has a backpack in life and it is OK to ask if you need help carrying it," she said, sharing her mother's words of wisdom, as well as what she had learned herself. "I was meant to be on this earth and I am worthy of being happy, my life is important."
This self-acceptance is a new language as she speaks to individuals about her recovery and renewed attitude on life.
Minding Your Mind Programs move away from crisis based response to prevention through education, according to their website.
"The mission of Minding Your Mind's primary objective is to provide mental health education to adolescents, teens and young adults, their parents, teachers and school administrators. Our goal is to reduce the stigma and destructive behaviors often associated with mental health issues. Treatment is available, yet only three out of 10 individuals needing help actually seek help.
"Our educational programs provide information regarding signs and symptoms of these disorders, in addition to stressing that they are treatable and treatment is available. Mood disorders have been identified by the World Health Organization as the third leading cause of disability worldwide. Research studies have demonstrated that over 90% of people that die from suicide have one or more psychiatric disorders at the time of their death. The second leading cause of death of individuals between the ages of 14-23 is suicide. Since the age of onset of most psychiatric disorders is typically during adolescence, it is essential that the proper information be brought to the attention of secondary school educators, counselors, students and their parents.
Minding Your Mind offers several programs for students, teachers, faculty and the community at large,' according to the website mindyourmind.org our programs aim to reduce stigma by promoting awareness about the prevalence of mental health disorders and the effectiveness of seeking help. The ultimate goal is to create a supportive environment in schools where students feel comfortable speaking up and asking for help.
Freezin' for a reason
HANSON — The January thaw was a blessing from Mother Nature as dozens of local residents, school officials and town employees made the plunge into the icy water at Cranberry Cove Sunday, Jan. 27 as part of the Hanon PTO Freezin' for A Reason inaugural polar plunge fund raiser.
Event Coordinator Melissa Valachovic of the Hanson PTO was enthused by the level of support that the community brought to the event.
Calling the event outcome "amazing," she reported the total raised by the plungers reached nearly $12,000.
Some of the top pledgers each exceeded $1,000 to $1,500.
With combined efforts of the PTO and a subcommittee assisting with the six month planning- prior to the event — Valachovic praised the abundant dedication and enthusiasm by many hands to bring the fund raiser to fruition.
Naming and thanking the town officials and first responders who contributed with safety of the 53 registered plungers, Valachovic acknowledged the entire board of selectman that made the plunge. Chairman Kenny Mitchell, who could not attend Sunday, took his frosty dive on Thursday in the presence of several witnesses.
Collectively giving to the school was the most important factor for most who powered through the chilly water although several carried individual reasons in participating.
Pam Fager and her lifelong friend Sondra Allen, both of Hanson, checked doing a polar plunge off their bucket lists.
Sharing childhood memories of summers gone by at Cranberry Cove the pair decided to take the icy dip contributing to the school that their children have attended.
"It was awesome and I cannot wait to do it next year," said Fager.
The water temperature was a concern for many as they saw the chunks of ice floating at the surface after Hanson firefighters and dive team members prepared the plunge area by sawing into the waterway.
"It actually felt similar to the air temperature," said Fager after she realized she accomplished the feat. Several plungers, in fact, said the water was not as cold as they had feared.
Enjoying the camaraderie of her small hometown, Allen said she would like to see more of those types of events.
"They really help bring the community together," said Allen. Some of her fondest childhood memories were at the boat races on Memorial Day and the huge bonfire held at the town hall on July 4.
Shaun Doyle, a police officer on the South Shore and a Hanson school parent, found a little extra motivation in the morning as he dressed for the polar plunge. He chose to honor his fellow brother in blue SGT. Michael Chesna, a fallen Weymouth police officer killed in the line of duty.
"It's nice at the end of the day — to give back — it's all about the kids," said Doyle.
Army Sgt. Aaron Meade a Hanson resident who graduated from W-H in 2002 said he had the memory of fellow Army soldier Black Hawk Pilot Scott Landis on his mind as he took a back flip into the chilly pond.
"I wanted to give back to the community," said Meade who made the trip from Hanscom Airbase where he is stationed.
Meade was overjoyed to have been cleared two days prior from a medical injury in which he was wearing a walking boot.
"I may feel this later," he said as he laughed off the cold.
Volunteers served hot cocoa and coffee to ice-cold bodies that were high on adrenaline. All participants were thanked deeply by organizers, wrapped in warming foils and given a cranberry colored commemorative towel as they exited the water.
Notably, some plungers such as Patrick Powers of the town Finance Committee and WHRHS Principal Dr. Christopher Jones, donned mismatched Hawaiian garb. Others looked pretty with headbands, Hawaiian skirts, bikini bathing suits and matching sunglasses, amusing hats and other costumes, which matched what appeared to be faces of exhilaration and relief.
Selectman Matt Dyer raised $260 of his $900 by taking up his father's challenge to wear a pink tutu, crown, bow tie and knee socks into the water.
The typically warm summer sand, which was hardened with cold, was alive with the sounds of musical genres — themed with winter weather lyrics, pumped up pledgers, family members and onlookers who packed the earth of the Cranberry Cove.
To see how many people participated and supported the plunge Valachovic commended onlookers many of whom contributed money on site.
"We are unbelievably grateful at the amount of support we couldn't have done this without them," she said.

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Here you will find one or more explanations in English for the word Polygamy. Also in the bottom left of the page several parts of wikipedia pages related to the word Polygamy and, of course, Polygamy synonyms and on the right images related to the word Polygamy.
Polygamy Po*lyg"a*my, n. [Gr. ?; cf. F. polygamie.] 1. The having of a plurality of wives or husbands at the same time; usually, the marriage of a man to more than one woman, or the practice of having several wives, at the same time; -- opposed to monogamy; as, the nations of the East practiced polygamy. See the Note under Bigamy, and cf. Polyandry. 2. (Zo["o]l.) The state or habit of having more than one mate. 3. (Bot.) The condition or state of a plant which bears both perfect and unisexual flowers.


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What's New NetflixMay 2021Resident Evil: Extinction
Resident Evil: Extinction: Release Date on Netflix
Resident Evil: Extinction came out in September (2007) but will it come to Netflix?
Here is everything you need to know about Resident Evil: Extinction release date on Netflix (USA). Details include the date it was added to Netflix, the ratings, cast, the plot, and more. Scroll down for more information.
Resident Evil: Extinction is a action movie directed by Russell Mulcahy. The film was initially released on September 21, 2007, and has a 6.2 rating on IMDb.
Resident Evil: Extinction is being released on Netflix on May 1, 2021. Let's look at the cast, movie plot, reviews, and what's new on Netflix. ⬇
Russell Mulcahy
Resident Evil: Extinction is came out coming out on Netflix on Saturday, May 1, 2021. We use publicly available resources such as NetflixSchedule and NetflixDates to ensure that our release date information is accurate. Some Netflix titles are considered original in one country but not in another and may not be available in your region. Additionally, dates may change, so check back often as we update this page.
September 21, 2007 (US)
You can start watching Resident Evil: Extinction at 3:01 AM ET (Eastern) on the east coast and 1:01 AM PT (Pacific) if you're on the west coast. And, 3:01 AM CT (Central), 2:01 AM MST (Mountain).
Survivors of the Raccoon City catastrophe travel across the Nevada desert, hoping to make it to Alaska. Alice joins the caravan and their fight against the evil Umbrella Corp.
Resident Evil: Extinction is starring Milla Jovovich, Oded Fehr, Ali Larter, Iain Glen.
IMDb: Resident Evil: Extinction has an IMDb rating of 6.2/10 based on 186,971 user votes.
Rotten Tomatoes: Rotten Tomatoes gave Resident Evil: Extinction a 88% score.
Please note, these reviews are only accurate at the time of writing. Resident Evil: Extinction reviews will be updated regularly.
Resident Evil: Extinction is rated: R. An R-rating is a caution by the Rating Board to parents as some content contains some adult material, and may include adult themes, strong language, violence, nudity, drug abuse or other elements. Parents are strongly urged to find out more about this film before they let their children under 17 attend.
Watch Resident Evil: Extinction on:
Who is the director of Resident Evil: Extinction?
Resident Evil: Extinction was produced by Screen Gems, Impact Pictures, Davis Films, Constantin Film, and Resident Evil Productions, with a budget of $45 million and was initially released on September 21, 2007.
Where you can stream Resident Evil: Extinction?
You can stream Resident Evil: Extinction on Amazon Video or Netflix. Visit Resident Evil: Extinction official website for more details.
Is Resident Evil: Extinction a Netflix Original?
Resident Evil: Extinction is a movie released in 2007.
When did Resident Evil: Extinction come out?
Resident Evil: Extinction was originally released on Friday, September 21, 2007. The film has been released approximately 15 years, 3 months, and 23 days ago.
Below are interesting links related to Resident Evil: Extinction:
– See what's new on Netflix May 2021.
– Find out what movies and shows came out on May 1st.
– Everything you should know about May 1, 2021.


New York Times bestselling author Michael Connelly sets his novels of suspense against a world divided by race, politics, money, and the media. Here he thrusts Detective Harry Bosch on a harrowing journey into a high-profile murder case--and darkness... An activist attorney is killed in a cute little L.A. trolley called Angels Flight, far from Harry Bosch's Hollywood turf. But the case is so explosive--and the dead man's enemies inside the L.A.P.D. are so numerous--that it falls to Harry to solve it. Now the streets are superheating. Harry's year-old Vegas marriage is unraveling. And the hunt for a killer is leading Harry to another high-profile L.A. murder case, one where every cop had a motive. The question is, did any have the guts?
SynopsisThis issue ... explores the many positive ways in which children and youth, in both the United States and abroad, in urban and rural settings, are taking advantage of new technologies to create projects with their own content. In the process, they are embarking on personal and community journeys that engage them in many facets of positive development.
SynopsisIntroduction to the Caribbean novel in English suitable for use as an undergraduate textbook.
SynopsisThis book covers the technology of the recovery of secondary fibre for its use in paper and board manufacture. The editor, who has had substantial practical experience of designing and commissioning paper recycling plants all over the world, leads a team of experts who discuss subjects including sourcing, characterisation, mechanical handling and preparation and de-inking.
SynopsisAn updated collection of more than 150 macrobiotic recipes includes information on how to incorporate a macrobiotic diet into a more nutritional lifestyle.
SynopsisHidden Human Computers discusses how in the 1950s, black women made critical contributions to NASA by performing calculations that made it possible for the nation's astronauts to fly into space and return safely to Earth. Aligned to Common Core Standards and correlated to state standards. Essential Library is an imprint of Abdo Publishing, a division of ABDO.
Free Download Food in the Social Order Online Book PDF ByMary DouglasTotal Download27If you only read the books that everyone else is reading, you can only think what everyone else is thinking.
SynopsisFirst published in 1984, This work is a cross-cultural study of the moral and social meaning of food. It is a collection of articles by Douglas and her colleagues covering the food system of the Oglala Sioux, the food habits of families in rural North Carolina, meal formats in an Italian-American community near Philadelphia. It also includes a grid/group analysis of food consumption.


Professor John Dewey was the leading intellectual spokesman in the United States for liberal-progressive-socialism, from the late 1800s through the first half of the 20th century. I have frequently written about his far-seeing strategy for the conquest of Western civilization by infiltrating the educational system. See The Corruption of Public Education: How It Happened.
Hitler, with his Hitler Youth program, had the same idea. Teach a one-sided and distorted set of dogma to impressionable and inexperienced young students and you will have converted many of them for life to the atheistic, materialistic, and statist religion of socialism.
The corrosive effectiveness of Dewey's strategy became undeniable in the 1960s and 1970s with the radical student activists. Today they would hardly be noticed. All of their doctrine now dominates classrooms, from kindergarten to graduate schools.
Since 1965, education at all levels has received substantial financial support from the Federal government. The price for that support is control of curricula by liberal-progressive-socialist educators.
First Amendment guarantees for freedom of religion are simply ignored. Taxpayers are compelled to finance proselytizing for an anti-Constitutional religion.