FDA Issues Guidance Helping Manufacturers Gain Access to REMS Drugs for Generic Development?

The FDA has issued guidance to assist in certain circumstances where brand-name drug companies refuse to sell to prospective Abbreviated New Drug Application (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 reference listed drug (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 is available at: REMS Drugs for Generic Development