User Fees

A leading cancer research advocacy organization is urging the Senate to include in its user fee package a bill that aims to increase development of therapies for childhood cancer.

The House passed FDA user fee legislation Wednesday afternoon (July 12) by voice vote, and lawmakers pressed the Senate to act quickly on the must-pass reauthorization package to avoid pink slips being sent to FDA employees at the end of the month.

A revised FDA user fee package set to face a House vote Wednesday afternoon under suspension of the rules largely combines the marked up House and Senate bills, and leaves out legislation crafted by industry and FDA to create an over-the-counter monograph user fee program.

A House FDA user fee measure that would use market incentives to boost generic competition for sole-source drugs could be bolstered by FDA chief Scott Gottlieb's newly unveiled list of off-patent drugs that lack competition.

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conduct pediatric studies on cancer drugs made for adults if the molecular target is the same as in children was withdrawn from discussions during the House Energy & Commerce Committee user fee markup Wednesday (June 7).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