User Fees

A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program.

Recently unveiled over-the-counter (OTC) monograph legislation is all the more important to reducing the monograph backlog given that FDA's fiscal 2018 budget justification maintains fiscal 2017 funding levels for the agency's OTC review processes, the Pew Charitable Trusts recently recently told Inside Health Policy.

The House Energy & Commerce Committee sent its user fee package to the floor, 54-0, Wednesday (June 7), tacking on several new amendments that deal with medical imaging, device servicing, accessory classification, a medical device safety pilot program and a sense of Congress urging the HHS secretary to take administrative actions to lower drug costs.

A measure that would require drug developers conduct pediatric studies on cancer drugs made for adults if the molecular target is the same as in children was withdrawn from discussions during the House Energy & Commerce Committee user fee markup Wednesday (June 7).

Rep. David McKinley (R-WV) told fellow House Energy & Commerce Committee members that he and Rep. Peter Welch (D-VT) plan to offer their bipartisan Risk Evaluation and Mitigation Strategy (REMS) bill during the committee’s markup of the FDA user fee package, saying concerns that the bill would endanger patient safety are unfounded.

On the eve of the House Energy & Commerce Committee's Wednesday (June 7) FDA user fee markup, health subcommittee member Rep. Diana DeGette (D-CO) spoke out publicly against GOP attempts to add controversial off-label amendments to the user fee reauthorization package.

The House Energy & Commerce Committee has tentatively scheduled markup of FDA user fee legislation for Wednesday (June 7), as talks continue on potential riders, including off-label amendments that Democrats have warned could derail their support for what so far has been a bipartisan user fee reauthorization effort.

Objections from the brand-drug and biotechnology lobbies prompted lawmakers to leave out for now from the user fee reauthorization package moving through Congress a bipartisan bill aimed at spurring pediatric cancer research, the architect of the pediatric bill told Inside Health Policy.

A House subcommittee easily passed FDA user fee legislation Thursday (May 18) with riders allowing over-the-counter hearings aids, requiring risk-based device inspections, offering new exclusivity for a new class of competitive generic drugs and restricting drug imports, and in the process brushed off the Trump administration's call for a doubling of the user fee levels FDA negotiated with industry.