Bioequivalence and Bioavailability Forum

Dear All

Yesterday FDA had issued draft guidance helping ANDA applicants gain access to REMS drugs for generic development titled as “How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain safety protections comparable to Applicable REMS for RLD”.

This guidance is part of FDA’s efforts to assist in certain circumstances where brand-name drug companies refuse to sell to prospective ANDA sponsors supplies of reference listed drugs.

The guidance describes how a prospective ANDA applicant can obtain a letter stating that FDA has determined:

• that the prospective applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD), and
  
• FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA.

The guidance is open for public and stakeholder comments for a period of 60 days, beginning Dec. 5, 2014.

Hope this would be a way forward for all the generic companies struggling with REMS controls.