April 26, 2017
(Washington, D.C.) — As the U.S. Senate looks to confirm Scott Gottlieb, M.D., to run the Food and Drug Administration (FDA), a new report identifies five policy priorities for the new commissioner that would promote greater prescription drug competition.
The report from Alex Brill, CEO of Matrix Global Advisors – “How the Next FDA Commissioner Can Address Drug Prices by Promoting Drug Competition” – notes that “widespread public frustration over drug prices is an indication that competition must begin receiving attention at the FDA comparable to what has been focused on innovation.” The report was sponsored by the Pharmaceutical Care Management Association (PCMA).
Click here to read the new white paper.
“Spurring more competition among brands and generics is the key to reducing drug costs,” said PCMA President and CEO Mark Merritt. “This report offers common sense, bipartisan steps the FDA – and Congress – can take in the near term.”
The report recommends five ways the FDA could foster competition and help reduce prescription drug costs:
- Encourage “First Generic” Applications. The FDA should reduce the review time for first generics – that is, generics for products that do not yet have a generic equivalent.
- Prevent Misuse of Risk Evaluation and Mitigation Strategies (REMS) Programs. Congress must give the FDA authority to prevent the misuse of REMS programs. Some brand manufacturers use these programs to deny access to drug samples for manufacturers that want to develop generic versions of brand products.
- Reduce Barriers to Generic Entry. The FDA should reduce the review period for standard ANDAs and ensure that generic user fees do not discourage firms from seeking approval for generic drugs.
- Dedicate More Resources to Brand-to-Brand Competition. Improve operational processes inside the FDA and, if necessary, provide more resources for the agency to expedite approvals for competing brand products.
- Streamline Application Process for Biosimilars. The FDA should carefully review biosimilar guidance and regulations and look for ways to facilitate the application process and reduce review times. The agency should also provide additional clarity and predictability to stakeholders on biosimilar interchangeability.
“Competition among pharmaceutical products takes many forms, and the FDA would be well advised to carefully consider strategies to foster these important market dynamics. Cost savings for payers as well as more innovation will ensue,” said Alex Brill.