Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We previously had preliminary information regarding a new Type D meeting format in PDUFA VII, and now we have the official details. Here's the breakdown - what it is, the associated timelines, and what to look out for in the future.

What It Is

The FDA has proposed Type D meetings to provide an opportunity to address more focused issues on a shorter timeline than other meeting types normally allow. Type D meeting requests could include:

• After a formal meeting, a follow-up question that raises a new issue (i.e., more than just a clarifying question about an FDA response from a prior meeting)
• A narrow issue on which the Sponsor is seeking Agency input with only limited questions
• A general question about an innovative development approach that does not require extensive, detailed advice

These meetings typically should not include more than two issues with associated questions and should not require input from more than three disciplines or Divisions. If the FDA feels that your particular request exceeds these thresholds and additional discussion is necessary, they may convert the meeting to the more appropriate meeting type. As is standard should that occur, it is up to the Sponsor to decide to accept the change or withdraw the request. You can still request a face-to-face (or teleconference) meeting, but the Agency ultimately decides if a written response to the questions would be best for providing feedback and advice.

The Timeline

Type D meetings offer significantly reduced response and scheduling time compared to Type B and Type C meetings. The Agency intends on responding to a meeting request within 14 calendar days and holding the meeting (or providing a written response) within 50 calendar days after receipt of the request. That means you will get your answers roughly 2.5 or 4.5 weeks quicker than Type B or Type C meetings, respectively. It is important to note that a Sponsor should request a Type C meeting rather than requesting several Type D meetings if the Sponsor has several issues or a complex single issue with multiple questions.

If the meeting request is accepted, the FDA will notify the requester in writing of the date, time, and whether it will be a teleconference or in person meeting, as well as the expected Agency participants.

Similar to Type A meetings, the meeting package must be provided at the same time as the meeting request. The meeting package should be tailored to the questions and provide only the background information necessary for FDA to respond. The Agency will send preliminary responses to the Sponsor’s questions from the meeting information package no later than five calendar days before the meeting date.

What to Look For in the Future

The Agency plans on phasing in their Type D performance goals starting in fiscal year (FY) 2023. By FY 2023, they intend on holding 50% of Type D meetings, or sending written responses, within 50 calendar days from receipt of meeting request. They expect a 10% increase in performance per year with a goal of 90% by FY 2027.

By September 30, 2023, we should anticipate updated Manual of Policies and Procedures (MaPPs), updated Standard Operating Procedures and Policies (SOPPs), and a revised draft of the existing draft guidance on "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" including Type D meeting information.

Finally, if you have issues, advice, or any lessons learned regarding Type D meetings that you would like to share with the Agency, you are encouraged to attend their Public Workshop to be held July 30, 2024. Further details regarding this event will be published with the updated "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" guidance.

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