The FDA’s MDUFA Accountability Questioned at Senate Hearing

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United States House of Representatives

This past Tuesday, Senator Richard Burr rebuked the FDA for failing to comply with the deadline set for January 15th for coming up with recommendations for a fifth MDUFA deal and failing to publish minutes of every industry meeting that concerned the agreement.  

This occurred during a user fee hearing held before the Senate Health, Education, Labor, and Pensions committee. Sen. Burr also rebuked the Food and Drug Administration for failing to meet the conditions of the agreement reached for the fourth MDUFA agreement. 

He stated that the FDA had a 3-month delay due to the refusal of the Center for Devices and Radiological Health (CDRH) to accept that the FDA didn’t accomplish all of the goals set on the last MDUFA and they wish for more money in exchange for mediocre improvements to performance and extended review times for certain equipment.

The Director of the CDRG, Jeff Shuren, informed the committee that the agency regrets the delay and acknowledged its failure to meet the performance goals set by the fourth MDUFA due to COVID-19-related duties and finite resources. 

Even so, Shuren reiterated that the FDA has engaged in long discussions that have resulted in a thoughtful agreement for the fifth MDUFA. If passed, it will lead to further innovation in the field of medical devices and greater program accountability. 

Fifth MDUFA Details

The fifth MDUFA deal is reaching the final stage of the legislative procedure after the House subcommittee hearing that took place last month, where lawmakers questioned the FDA about the hold-up related to reaching an industry agreement. 

Under the fifth MDUFA, the FDA is set to obtain $1.78 billion in user fees from 2023 and 2027. The amount could be increased to $1.9 billion should the agency meet specific goals regarding performance.

FDA Criticisms During Senate Hearing 

The objective of the Senate hearing held this last Tuesday was to consider the commitment letters the industry and FDA submitted for the reapproval of biosimilar, generic drug, prescription drug, and medical device user fee deals. Nonetheless, only the FDA’s fifth MDUFA deal was missing a congressional deadline. CDRH’s Director Shuren expressed his regret at missing the deadline. 

Sen. Burr still criticized the CDRH’s insufficient transparency as they failed to publish the minutes from seven industry meetings since this past February. Something they needed to do before providing Congress with the MDUFA commitment letter. 

Shuren guaranteed the meeting minutes would be published this week and the FDA has since performed a website update. He also assured the committee that the delay was due to ongoing negotiations with industry parties. 

Essentially, they were primarily focused on reaching an agreement and they would handle the minutes afterward. Additionally, Shuren stated that the agency would have the final package for the fifth MDUFA delivered to Congress by the end of this upcoming week. 

Final Words

Sen. Burr communicated that the fifth MDUFA agreement authorization may not be smooth. He stated that if the agency expects Congress to approve a money increase in exchange for lower accountability expectations and zero accountability for previous issues, they are mistaken in that assumption. 

Burr made it clear that the legislation that will be submitted to a vote in a couple of weeks needs to hold the FDA responsible not only for its past actions but also for its inactions.

Senator Patty Murray, chair of the health committee, also highlighted that the reapproval of user fee programs has been provided by Congress practicing bipartisanship and wishes to collaborate with Sen. Burr and other committee members to get the issue resolved as soon as possible. 

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