FDA legislation and regulatory implementation issues
H.R. 2182, Generating Antibiotic Incentives Now (GAIN) Act (S.1734)
Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub.
L. 111-152) Congressional deficit reduction negotiations and Deficit Reduction Commission, following passage of the Budget Control Act of 2011 (P.L. 112-25).
H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act; H.R. 5651, Food and Drug Administration Reform Act of 2012,
S.3187, Food and Drug Administration Safety and Innovation Act; issues pertaining to antibiotic incentives, drug safety pedigree, and drug supply chain.
Medical research.
Antibiotic resistance issues.
S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act
Address concerns regarding uncertainty and unpredictability of FDA drug and device regulatory environment. Support drug and device user fee legislation. Address concerns with Medicare Independent Payment Advisory Board (IPAB). Support repeal of medical device tax. Support extension of R&D tax credit. Medicare home infusion and reimbursement issues.
340B issues.
H.R. 2195 / S. 1203, Medicare Home Infusion Therapy Coverage Act of 2011.
H. Con. Res 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions). Pub. L. 111-148, Patient Protection and Affordable Care Act (implementation).
Pub. L. 111-152, Health Care and Education Reconciliation Act of 2010 (implementation).
H.R. 5194, Rural Hospital and Provider Equity and 340B Improvement Act of 2012.
H.R. 5624, Rural Hospital and Provider Equity and 340B Improvement Act of 2012.
Address concerns with Medicare Independent Payment Advisory Board (IPAB). H. Con. Res 112, Establishing the budget for the US Government for FY 2013 (Medicare-related provisions).
H.R. 5973 / S. 2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act,
2013. Labor/HHS/Ed Appropriations: NIH, biodefense/pandemic, science/math education, and strategic stockpile funding and preparation;
FDA Appropriations. Support protection of US law regarding biosimilars (12 years data exclusivity). Antibiotic resistance issues.
Pay-for-delay proposals and generic issues.
H.R. 2182 / S. 1734, Generating Antibiotic Incentives Now Act of 2011.
Prescription Drug User Fee Act reauthorization. S. 2516, Food and Drug Administration Safety and Innnovation Act.
S. 2292, Patients' FDA Act
S. 2289, Better Pharmaceuticals and Devices for Children Act of 2012.
S. 1734 / H.R. 2182, Generating Antiobiotic Incentives Now Act (GAIN Act) - incentives for development of products to treat
antibiotic-resistant infections;
S. 3187, Food and Drug Administration Safety and Innovation Act - incentives for development of products to treat
antibiotic-resistant infections;
ADDENDUM for General Lobbying Issue Area: PHA - Pharmacy
H.R. 5651, Food and Drug Administration Reform Act of 2012 - incentives for development of products to treat
antibiotic-resistant infections
HCR - Health Issues TAX - Taxation/Internal Revenue Code MMM - Medicare/Medicaid BUD - Budget/Appropriations PHA - Pharmacy
135 - Food & Drug Administration (FDA) 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 135 - Food & Drug Administration (FDA) 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 135 - Food & Drug Administration (FDA) 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 135 - Food & Drug Administration (FDA) 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 135 - Food & Drug Administration (FDA) 2 - HOUSE OF REPRESENTATIVES 1 - SENATE
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