FDA Reauthorization Act aims to lower costs of ‘overpriced’ generic drugs
The long-term effects of the FDA Reauthorization Act of 2017 — signed into law by President Donald J. Trump on Monday — may include savings in drug-related Medicare expenses due to increased competition encouraged by the FDA by fast-tracking generic competitor approvals, according to an expert.

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FDA Reauthorization Act aims to lower costs of ‘overpriced’ generic drugs

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David Gortler



The long-term effects of the FDA Reauthorization Act of 2017 — signed into law by President Donald J. Trump on Monday — may include savings in drug-related Medicare expenses due to increased competition encouraged by the FDA by fast-tracking generic competitor approvals, according to an expert.

“All things considered, this bill is mostly a good thing,” David Gortler, PharmD, FCCP, a professor of pharmacology and biotechnology at the George Washington School of Medicine & Health Sciences and a pharmacology and drug safety expert with the consulting group FormerFDA.com told Healio.com. “It has been praised by several long time FDA officials and seems to give the FDA more power in several areas. Even President Trump's most vigilant detractors will be hard-pressed to find faults with the FDA Reauthorization Act.”

Passed by the U.S. House of Representatives by a voice vote in July and by the Senate in August, the FDA Reauthorization Act of 2017 (H.R. 2430) aims to reauthorize the Prescription Drug User Fee Act, the Medical Device User Fee Amendments, the Generic Drug User Fee Amendments and the Biosimilar User Fee Act and includes several provisions to improve the FDA’s drug review process.

The act would ensure the FDA has the tools to deliver safe and effective drugs, devices and treatments to patients more swiftly, according to a press release from the Energy and Commerce Committee.

In an interview with Healio.com, Dennis R. Cryer, MD, co-convener of the Biologics Prescribers Collaborative and chief medical officer at CryerHealth, said the Biologics Prescribers Collaborative commends the passage of the act, as well as the reauthorization of the Biosimilar User Fee Agreement.

“The Biosimilar User Fee Agreement provides needed resources for [the] FDA to accelerate patient access to safe and effective biosimilars,” he said. “This BsUFA reauthorization reinforces FDA’s role to advance treatment options, including biosimilars.”

One of the significant possible medium- and long-term benefits of the act is the savings in Medicare costs associated with generic drugs that do not have any market competition, according to Gortler.

“We have seen the prices of some of these historically inexpensive generic ‘niche’ drugs like pyrimethamine (Daraprim, Turing Pharmaceuticals) randomly go up quite high when they do not have competitors,” he said. “There are provisions in the FDA Reauthorization Act to give priority review status to generic drug applications to lower the costs of these overpriced drugs, devices or biosimilar compounds.”

Additionally, Gortler said that there is a “a well-needed provision [in the act] for collecting real-time clinical use data from patients earlier in the development and marketing of a new drug, as opposed to relying solely on clinical trial findings.”

However, Gortler noted that the act did little to address important positions still unfilled at the FDA.

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“The FDA has had a long history of not filling key scientific positions at the agency,” he said. “While this act did little, if anything, to address the FDA’s hiring problems, it does integrate a Merit System Based Incentive Payment System, which the FDA wants to hopefully maintain employment of its existing scientific staff. This might be my only critique of the act — FDA employees are already some of the best paid employees in the federal government, with perks [that include] flexible work hours and the ability to work from home up to 2 days per week. Although pharmaceutical industry jobs can pay considerably more, there is a huge risk in job security and a significant difference in quality of life with regards to available free time. I can personally attest to the same, having worked in both capacities.” – by Ryan McDonald

References:

https://energycommerce.house.gov/news-center/press-releases/senate-follows-house-passes-bipartisan-bill-reauthorize-fda-s-user-fee

Disclosures: Cryer and Gortler report no relevant financial disclosures.