Health Reform WK-EDGE HELP committee advances FDA user fee agreements to Senate floor
Monday, May 22, 2017

HELP committee advances FDA user fee agreements to Senate floor

By Sarah E. Baumann, J.D.

By a vote of 21-to-two on May 11, 2017, the Senate Committee on Health, Education, Labor & Pensions advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 for consideration before the full Senate. The bipartisan act comprises the prescription drug user fee act (PDUFA), the medical device user fee amendments (MDUFA), the generic drug user fee amendments (GDUFA), and the biosimilar user fee act (BsUFA). Committee chair Sen. Lamar Alexander (R-Tenn), who co-sponsored the bill with ranking member Patty Murray (D-Wash), emphasized the urgent need to reauthorize the bill before the August recess to avoid FDA layoffs and halt medical innovations when the existing agreements expire on September 30, 2017.

The Act renews FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs, and biosimilars. The user fees account for more than one-fourth of all FDA funding, or about $8 to $9 billion over a five-year period. Specifically, fees generated by PDUFA accounted for more than 70 percent of the brand drug review budget in fiscal year (FY) 2016; fees generated by MDUFA accounted for 36 percent of the medical device review budget; fees generated by GDUFA accounted for more than 75 percent of the generic drug review budget; and fees generated by BsUFA accounted for 29 percent of the biosimilar review budget.

The FDA Reauthorization Act has been the subject of numerous hearings before both the Senate HELP Committee and the House Energy and Commerce Committee (see Discussion draft of FDA user fee amendments is on the table, April 18, 2017; HELP Committee hears ardent support for next round of user fee agreements, April 4, 2017; Committee holds optimistic hearing on medical device fees, March 29, 2017; PDUFA VI reauthorization would aid 21st Century Cures Act implementation, March 23, 2017; and User fee program reauthorizations necessary for product development, March 3, 2017). Alexander cautioned that failure to reauthorize the Act would lead the FDA to send layoffs to more than 5,000 employees, notifying them that they may lose their jobs within 60 days, and could halt drug research. Sen. Murray emphasized the bipartisan nature of the bill, using her remarks to exhort senators to display similar bipartisanship in crafting health care reform in general, noting that they shouldn’t "retreat to partisan corners and negotiate in secret along party lines" but exhibit "collaborative, bipartisan work."

MainStory: TopStory NewsFeed NewsStory AgencyNews BiosimilarNews BiologicNews DrugNews MedicalDeviceNews

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