CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee

Regulatory News

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

All three officials highlighted the past successes of the user fee programs, and overall, it did not seem as though user fee goals letters would be reworked or that further negotiations would be needed before the bills are marked up, voted on and sent to President Donald Trump for his signature.

Sen. Lamar Alexander (R-TN) noted this is the first time the user fee programs have sunset in a new administration and he said that any additional add-ons senators want to attach to the agreements will need to be bipartisan and deal with medical products.

Many of the Democrats on the committee, however, used the hearing to lambast Republicans for not discussing the Obamacare replacement bill making its way through the House.

“I’m deeply concerned we have a major health bill that’s moving through Congress without hearings,” Sen. Patty Murray (D-WA) said.

But Alexander stressed the importance and bipartisan nature of these user fee reauthorizations, trying to make clear the devastation that would occur at FDA if Congress failed to reauthorize the programs by a 27 July deadline.

Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), noted that about one-third of CDRH’s staff would be cut without a new user fee deal. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), noted that layoffs would be coming if a deal is not reached.

PDUFA, GDUFA, BsUFA and MDUFA

Shuren, Woodcock and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), all explained how the user fee programs have sped up the approvals of new medical products and provide industry with a more predictable timeline for meetings with the agency and approvals.

Concerns were raised by several members about FDA’s ability to approve new and first generic drugs to increase competition and bring down pharmaceutical costs.

But Woodcock noted that FDA is only currently reviewing six first generics and nine sole-source generic drugs, or generics with only one competitor. She also noted that FDA is still working to reduce the number of review cycles generic drug applicants go through before approval and that FDA has been working with generic companies to try to ensure that they can obtain samples of reference products necessary to run bioequivalence tests and win approval.

Marks also explained CBER’s role in reviewing new gene and cell therapies, noting that although none have been approved, there are more than 550 active investigations testing these new therapies.

Shuren explained how the medical device user fee agreement has helped to reduce the review times for device trials and 510(k) and pre-market approval applications.

The only pointed criticisms from the hearing came from Sen. Richard Burr (R-NC), who asked each of the officials if their centers would return user fees to industry if certain milestones were not met. And though all three witnesses said they would, Burr pressed them on failures to meet hiring goals.

Sen. Elizabeth Warren (D-MA), meanwhile, took a shot at the Trump administration’s repeated claims that it will reduce FDA regulations further to speed new products to market.

“There’s not a lot of evidence that this administration wants FDA to work,” she said. “Let’s be clear, if the Republican bill to gut health care becomes law, all of these speedy approvals won’t matter if no one can afford them.”

FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients Part I