User Fees

Senate Majority Leader Mitch McConnell (R-KY) announced Tuesday (August 1) that Republicans want to vote on the FDA user fee package before the August recess, but one industry source tells Inside Health Policy that while Republicans want to move on the legislation next week, Democratic and Republican leadership have not yet agreed on an amendment package.

Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ) are attempting to attach the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, to the user fee package expected to be taken up by the Senate this week, a Democratic lobbyist tells Inside Health Policy.

The medical device lobby will seek to add a rider permanently repealing the medical device tax to the Senate user fee package -- despite previous concerns that the rider could not be added due to jurisdictional issues -- if the tax is not repealed as part of health reform efforts.

FDA Commissioner Scott Gottlieb wrote to FDA staff Monday (July 24) that the agency will not issue layoff notices to user fee-funded employees until Sept. 30, buoyed by confidence that the user fee package will be signed into law before the existing authorizations lapse.

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.