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Bipartisan Committee Leaders Request Briefing on Reporting Requirements for Generic Drugs

Mar 6, 2020
Press Release

Bipartisan Energy and Commerce Committee leaders sent a letter to the Food and Drug Administration (FDA) Commissioner Dr. Stephen M. Hahn to request a briefing on the marketing status reporting requirements of generic drugs required by the FDA Reauthorization Act of 2017 (FDARA).

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO), and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) sent the letter. 

"Promoting a competitive marketplace depends in part on FDA’s timely approval of generic drugs and biosimilars, and in part on transparency about the marketing status of approved products," the bipartisan leaders wrote in the letter to the FDA.

FDARA is a bipartisan approach to increase competition in generic drugs, and decrease drug costs, through among other things the reauthorization of four user fee programs. The goal is to strengthen several review processes, including that of drugs. To improve transparency, FDARA requires certain drug applicants to notify FDA on marketing status, withdrawals from the market, and if the drug will not be for sale within 180 days from FDA approval.

"Since this provision in FDARA was passed into law, we have heard about additional ways that some drug manufacturers may be manipulating the market to harm competition and raise prices.  A complaint filed by the Attorney General of Connecticut and a 44-state coalition in May 2019 details instances where generic manufacturers allegedly exited the market temporarily to suppress competition and fix prices," bipartisan committee leaders continued.

The following information is requested for the briefing:

  • Temporary market withdrawals reported to FDA as required by section 804 of FDARA.
  • How is FDA monitoring and tracking marketing status information?
  • Is FDA addressing gaps or overlaps in information manufacturers must report when withdrawing from the market. If so, how?

To read the letter, click HERE.