New FDA Draft Guidance on Dispute Resolution: An Important Appeal Pathway for Drug Companies

On March 13, 2013, FDA announced in the Federal Register the availability of an FDA draft guidance, titled “Formal Dispute Resolution: Appeals Above the Division Level.”  Formal dispute resolution affords sponsors a mechanism by which they can appeal scientific and procedural decisions by FDA.  For human drug applications under PDUFA, FDA’s performance goal is to provide a response within 30 days of receiving an appeal.  Here at Hogan Lovells, we’ve worked with pharma and biotech companies in using the formal dispute resolution process to appeal adverse agency decisions related to the review and approval of new drugs, among other things. The draft guidance, available on the FDA website, revises a previous formal dispute resolution guidance from February 2000.  In the new draft guidance, FDA stated that it revised the previous guidance to “update procedures and policies to reflect current practice.”  Much of the draft guidance remains unchanged from the prior February 2000 version, but the agency did make the following additions:  

  • Sponsors now have the option to request a Type A meeting as part of their formal dispute resolution requests.  The previous February 2000 guidance stated that FDA could schedule a Type A meeting when acting upon a sponsor’s appeal, but did not specifically describe an option for sponsors to request a Type A meeting themselves.  Under the draft guidance, FDA will grant or deny a sponsor’s Type A meeting request made as part of an appeal within 14 days.  After holding a Type A meeting as part of a formal dispute resolution proceeding, the agency is then allowed 30 days following the meeting to decide the appeal, so that it may “consider the discussion at the meeting in its decision making process.”  
  • The draft guidance also adds new descriptions of possible interim responses that FDA may make in responding to an appeal.  These descriptions provide additional information on the actions that FDA may take in lieu of issuing a final decision within 30 days of receiving a sponsor’s dispute resolution request.  FDA may issue an interim response to an appeal when it “needs additional clarifying information or input from other persons knowledgeable in the matter to reach a decision.”  FDA may request this information from the sponsor directly, arrange a meeting with the sponsor, hold a discussion with advisory committee members or experts, or request an advisory committee review.  FDA has provided specific timeframes for it to take action in each of these scenarios.
Overall, the new draft guidance does not appear to signal any intentions by FDA to implement significant formal dispute resolution changes.  However, the newly-added option for sponsors to request a Type A meeting and the detailing of specific interim responses by the agency may lend some additional structure to the appeals process.

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