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Press Release

#SubHealth to Markup Bipartisan FDA User Fee Reauthorization THURSDAY


WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), has announced it will markup the FDA Reauthorization Act of 2017 on Thursday, May 18, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building.

In April, bipartisan leaders of the Energy and Commerce Committee, along with bipartisan leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, reauthorizing FDA’s user fee agreements. The draft followed hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA).

“After an informative series of hearings on the individual user fee agreements, we’re ready to advance the underlying bill and proceed with the timely reauthorization of these important programs,” said Chairman Burgess. “The FDA Reauthorization Act of 2017 will ensure that FDA has the tools they need to deliver safe and effective products to patients more quickly.”

#SubHealth will also markup two public health bills that the committee held hearings on last Congress – H.R. 1222, the Congenital Heart Futures Reauthorization Act of 2017 and H.R. 2410, the Sickle Cell Disease Research, Surveillance, prevention and Treatment Act of 2017. H.R. 1222 would enhance research and surveillance at the CDC, award grants to further study Congenital Heart Disease, and direct the NIH to report on their ongoing research efforts. H.R. 2410 reauthorizes the sickle cell disease prevention and treatment demonstration program.

Electronic copies of the legislation and a background memo can be found on the Energy and Commerce Committee’s website here. Amendment text and votes will be available at the same link as they are posted.


Health (115th Congress)
Press Release