FDA Releases Draft Guidance Clarifying Dispute Resolution Above Divisional Level

The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request.

In draft guidance, the agency says companies may file an FDRR for any of the following:  

• Complete response letter;
• IND clinical hold, either partial or full;
• Denied request for breakthrough therapy status;
• Denied request for proprietary name review; and
• Refuse to receive an ANDA.

FDRRs should only be filed for regulatory actions relating to applications for user fee products, and must involve significant scientific or medical issues. All dispute resolution pathways within the initial review division must be exhausted before an FDRR will be considered, the FDA says. The five actions identified in the guidance are not an exhaustive list.

Drugmakers pursuing an FDRR should provide a brief overview of the issues, including past regulatory history and supporting documents for the conflict and proposed solutions and outcomes, but should not include any new information, according to the draft guidance, which updates a two-year-old draft.

While new information may change a case, the internal agency review must be based on the same information to which the original deciding body had access, the agency explains. Drug companies wishing to present new information— or new analyses of existing information — should first submit it to the division and officer that originally reviewed the application.

FDA decision makers may investigate a conflict further through sponsor meetings, discussion with members of an advisory committee or internal or external experts or an advisory committee review, the guidance says. Disputes that aren’t satisfactorily resolved at the highest levels of CDER or CBER may be appealed to the FDA Commissioner’s office for evaluation.

The guidance sets a 30-day goal for responding to FDRRs, but says the timeframe may be extended if the FDA requests clarifying information.

Comments are due Dec. 8 to docket no. FDA-2013-D-0221.  View Formal Dispute Resolution: Appeals Above the Division Level, here: www.fdanews.com/09-09-15-dispute.pdf. — Victoria Pelham