US FDA User Fees

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

Following a consultation last year, Medsafe has set new fee levels that take account of both cost-recovery principles and a 4.2% increase in the consumer price index. 

House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.

Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.

Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

The House Energy & Commerce Committee is moving rapidly to complete work on a bipartisan reauthorization of the US FDA’s user fee programs – and it isn’t waiting for any riders that aren’t ready on time. For now, at least, that means the CURES 2.0 bill will have to find another track.

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.

By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.