User Fees

The Senate health committee answered the calls of pediatric research advocates by including a number of riders in user fee reauthorization legislation, released Monday (May 8), meant to facilitate pediatric drug and device development, including requiring FDA: analyze real-world evidence on off-label uses of medical devices in children; issue guidance on pediatric drug development; and create an internal pediatrics team.

Stakeholders clashed over a bipartisan bill that would require third-party device servicers to register with FDA and submit adverse event reports, causing lawmakers to think twice about their idea of attaching the bill to FDA user fee reauthorization legislation.

A group of Democratic lawmakers is asking FDA Commissioner-nominee Scott Gottlieb to expand on how, if confirmed, he would ensure FDA is sufficiently staffed and funded, how a hiring freeze would affect his ability to lead the agency and how he would implement hiring provisions under 21st Century Cures.

The American Academy of Pediatrics laid out priorities for user fee reauthorization that would expand on the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), including making permanent the BPCA's National Institutes of Health program that funds studies on use of off-patent drugs in children.

Senate health committee Chairman Lamar Alexander (R-TN) said he hopes to move quickly to reauthorize the user fee agreements negotiated by FDA and industry so that the agency won't be forced to send layoff notices to employees at the end of July.

The American Academy of Pediatrics (AAP) is pushing a slate of Pediatric Research Equity Act (PREA) reforms it wants attached to user fee reauthorizations, including requiring drug manufacturers developing orphan drugs to study those drugs for pediatric indications when the science shows the drug could be used to treat kids, and closing what the group sees as a loophole in the law allowing sponsors to benefit from orphan drug designations without conducting pediatric studies.

The House is unlikely to honor President Donald Trump’s budget request to double user fees, a House GOP aide told Inside Health Policy Wednesday (March 22), emphasizing that key committees have already began considering the user fee commitments agreed upon between FDA and industry.

There are less than 20 pending generic applications for drugs currently without competition, FDA drug center chief Janet Woodcock told Senate health committee lawmakers Wednesday -- prompting a key Democrat to call for more sweeping action on drug pricing.

All 11 Senate health committee Democrats are asking Chair Lamar Alexander (R-TN) to essentially put off Tuesday's FDA user fee hearing and instead hold a hearing on the House GOP's health care bill.