Coalition Letter to FDA regarding transparency of the MDUFA V reauthorization process

Lauren Roth

Associate Commissioner for Policy

Center for Devices and Radiological Health

Food and Drug Administration

Dear Ms. Roth,

We write today to follow up on your response to several requests for information at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Medical Device User Fee Amendments (MDUFA V) stakeholders meeting on February 28, 2022.

The FDA has an obligation to provide clear, concise, and accessible information to the public and Congress throughout the MDUFA reauthorization process, as has occurred during prior reauthorizations. Information has been provided on the FDA website, however none of the information has been updated in over nine months. For example, for MDUFA IV, the summary notes from 13 meetings between FDA and industry were posted, along with minutes from 11 stakeholder meetings. In comparison, notes from seven MDUFA V meetings between FDA and industry have been posted, and minutes from only two stakeholder meetings have been posted. The most recent meeting notes from industry discussions that are publicly accessible on the FDA’s website are from the meeting on June 30, 2021. The most recently posted meeting notes from the stakeholder meetings are from a meeting on April 14, 2021. Further, the stakeholder meeting documents should include any PowerPoint slides shared in addition to a list of attendees, the online chat during the meeting, and a summary of the meeting discussions and answers to questions.

In answer to one of the stakeholder questions on February 28, 2022, you stated that “We don’t negotiate policy.” Please clarify if you are referring specifically to the FDA/industry MDUFA negotiations, and whether the statement is based on statute, regulation, or tradition.

Since the MDUFA negotiations between FDA and the medical device industry take place behind closed doors, making meeting notes available to stakeholders is a critical component of the MDUFA process. As nonprofit organizations that have engaged in the MDUFA process, we have a responsibility to provide updates on the status of this important program to our memberships and the American public whose taxes support the FDA’s mission. We are unable to fulfill this responsibility without complete, transparent information from the FDA. We currently must rely on monthly meetings – some of which are rescheduled or shortened at the last minute – to gain even a limited understanding of the status of the program and reauthorization process.

During the last stakeholder meeting on February 28, 2022, you stated that the FDA has met with industry at least five times in the month of February in an attempt to reach an agreement on the MDUFA Commitment Letter, including February 3, 8, 10, 15, 17, 22, and 24. As of March 4, 2022, no written information has been provided to the public regarding the substance of these important meetings. More outrageous, no written information about any of these meetings held since June of last year are available online. As a public health agency funded by U.S. taxpayers, information about all of FDA’s user fee negotiations with industry should be publicly available. Given the significant delay in submitting the MDUFA V Commitment Letter to Congress, which was due January 15, 2022, it is essential that CDRH updates the public and Members of Congress with the contents of these closed-door meetings. This should include a list of the individuals and affiliations of all those who attended, what was discussed, and what next steps will take place.

If the meeting notes from meetings held since June 2021 are indeed currently available somewhere on the FDA website, they are difficult if not impossible to find, which runs counter to the commitment to accessibility. We appreciate your attention to this important matter.



Breast Implant Safety Alliance

Medical Device Problems

National Center for Health Research

Patient, Consumer, and Public Health Coalition

Patient Safety Action Network

USA Patient Network


Senator Patty Murray

Chair, Senate Health, Education, Labor, and Pension Committee

Senator Richard Burr

Ranking Member, Senate Health, Education, Labor, and Pension Committee

Representative Frank Pallone

Chair, House Energy and Commerce Committee

Representative Cathy McMorris Rodgers

Ranking Members, House Energy and Commerce Committee

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