Regulatory Focus™ > News Articles > Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

Posted 10 March 2015 | By Alexander Gaffney, RAC

Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product.

Background

Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called "user fees."

Those user fees are meant to offset the cost of reviewing products, and to allow FDA to hire more staff to review products more quickly. In return for this funding, and as part of the PDUFA agreement, FDA has agreed to review more products under certain timelines. For example, the agency reviews most normal drug products within 10 months of its submission to FDA, and most high-priority drugs within six months of submission.

But approval is just the end goal for new product submissions. Prior to that, regulators and new product sponsors usually meet several times to iron out various details about potential areas of concern:  Is there sufficient data to approve the drug? Are there details which require clarification by the sponsor?

These interactions are organized around three "types" of meetings:

  • Type A meetings, which are used to help "an otherwise stalled product development program proceed."
  • Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.
  • Type C meetings, which is a catch-all category for any meeting which falls outside of Types A or B.

New Guidance on How to Request and Conduct PDUFA Meetings

Under PDUFA—specifically PDUFA Reauthorization Performance Goals and ProceduresFDA is supposed to schedule these meetings within fairly strict timeframes to ensure that the development of a drug is not slowed down unnecessarily. When PDUFA was revised in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA was also tasked with tightening these deadlines further.

For example, Type A meetings should be scheduled within 30 days of FDA receiving a meeting request. Type B meetings should be scheduled within 60 days of FDA's receipt of the meeting request, "except in the most unusual circumstances."

FDA also advises sponsors to "anticipate future needs."

"Generally, with the exception of products granted breakthrough therapy designation status, we will not grant more than one of each of the Type B meetings for each … application," FDA explains in its new draft guidance, Formal Meetings between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products.

Type C meetings, meanwhile, should be scheduled by FDA within 75 days.

FDA's guidance also contains information regarding the information that should be contained in each meeting request, as well as procedures for how FDA intends to decide if a request should be granted. Meeting decisions will be made within 14 days for Type A meetings and 21 days for Types B and C meetings.

Sponsors will also need to take care to have their work and questions ready for FDA far in advance of some meetings. "Meeting Packages" containing information relevant to the meeting should be sent to FDA at least one month in advance of the meeting (or concurrently with Type A meeting requests). This is meant to allow FDA to "develop responses to issues raised by the [meeting] requester or review division."

FDA says summary data—not full study or trial reports—should be included in the meeting requests.

Comments on the new draft guidance are due to FDA in 90 days.

 

Formal Meetings between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products (FR)


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe