User Fees

The National Organization for Rare Disorders (NORD) commended the sixth drug user fee agreement, released July 15, for its potential benefits to the rare disease community, but a NORD official told Inside Health Policy that the group will work with lawmakers to offer amendments to the bill.

FDA and the drug industry have agreed on performance goals for the sixth iteration of the drug user fee law that echo key objectives of the House-passed 21st Century Cures Act, including: enhancing adaptive, Bayesian and other clinical trial designs, incorporating the patient voice in drug development and enhancing the review of combination products.

The American Academy of Pediatricians (AAP) says its near decade-long press for FDA to establish safety and efficacy of over-the-counter cough and cold products for children shows a dire need to reform the OTC monograph process and increase agency resources through a user fee program.

FDA and the medical device industry continue to disagree on key issues as discussions continue on how to craft the next device user fee law, according to minutes of an April 27 meeting between the parties.

Key medical device lobby groups told FDA at a recent meeting that the agency's high-priority goals for the next user fee law don't match industry's, and said their members oppose the agency's real-world evidence funding plan and other proposals they believe are not worth the investment and don't fit into the scope of the user fee program, according to minutes from the March meeting.

FDA drug chief Janet Woodcock gave a small opening to the agency factoring drug price spikes in how it queues generic drug approvals, telling a Senate panel Thursday that such a policy might be possible if HHS came up with a “bullet proof” way of defining a price spike.

FDA drug center chief Janet Woodcock will testify at a Senate health committee hearing Jan. 28 on whether the generic drug user fee law has provided the overhaul necessary to ensure patients have expeditious access to generic drugs.

Energy and Commerce Committee Chair Fred Upton (R-MI) praised the spending package passed last week saying that it provided FDA with an increase near to what the 21^st Century Cures Act sought in fiscal year 2016.

As lawmakers debate how much funding to provide FDA in 2016 and the drug and device user fees talks enter the substantive stages, millions of dollars gathered from previous user fee agreements sit in the Federal Treasury as a result of a previous legal glitch, industry representatives say.