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Bicameral Health Committee Leaders Request Update from FDA on Delayed MDUFA Agreement

Jan 28, 2022
Press Release
Members: “The FDA and medical device industry’s significant delay in transmitting the MDUFA commitment letter jeopardizes our ability to thoroughly review the commitments under the letter.”

Today, leaders of the House Committee on Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA), and the Senate Committee on Health, Education, Labor and Pensions Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC), sent a letter to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock to request an update on the timeline for transmitting the commitment letter for the Medical Device User Fee Amendments (MDUFA) to Congress. 

The FDA was required by law to submit its final commitment letter to Congress on or before January 15, 2022. To date, the medical device agreement is the only agreement that remains to be submitted to Congress, with the final prescription drug, generic drug, and biosimilar agreements transmitted before the deadline.

“It is important that Congress have sufficient time to review each commitment letter and to evaluate the agreements,” the Members wrote. “The FDA and medical device industry’s significant delay in transmitting the MDUFA commitment letter jeopardizes our ability to thoroughly review the commitments under the letter.

“We respectfully request a briefing with FDA and industry representatives, no later than Wednesday, February 9, to update us on the progress made toward reaching an agreement and the expected timeline under which the parties will be able to publish a draft agreement and transmit a final commitment letter to our respective committees,” the Members continued. 

To read the full letter, click here.

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