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.
Prospective ANDA sponsors need supplies of reference listed drugs to conduct bioequivalence (BE) and other testing to support their ANDAs.
The problem of generic companies’ inability to obtain reference listed drug supplies can arise where the drug product is not available through regular distribution channels because it is subject to distribution restrictions (imposed either through a Risk Evaluation and Mitigation Strategy (REMS) or voluntarily by the RLD holder).
Because some brand-name drug companies argue that providing adequate supplies of the reference listed drug to prospective ANDA sponsors would violate their REMS, FDA has developed a process to provide assurance to the brand-name drug company that the Agency has reviewed the generic company’s bioequivalence study protocols and determined that they contain safety protections comparable to those in the REMS.
The guidance describes how a prospective ANDA applicant can obtain a letter stating that FDA has determined:
prospective ANDA applicant’s bioequivalence study protocol contains safety protections comparable to those in the REMS for the reference listed drug, and
FDA will not consider it a violation of the REMS for the reference listed drug holder to provide a sufficient quantity of the reference listed drug to the prospective ANDA sponsor or its agent to allow the company to perform the testing necessary to support its ANDA.
FDA welcomes public and stakeholder comments to the public docket for a period of 60 days, beginning Dec. 5, 2014.