The FDA wants to make it easier for generics firms to acquire samples from brandmakers who claim drug safety protocols prevent them from selling the products for bioequivalence testing.

Draft guidance published last week formalizes the process that ANDA filers must follow to request an agency letter to brandmakers assuring them that the generics firm’s safety protocols will be in compliance with the risk evaluation and mitigation strategies (REMS) of the reference therapy.

In the request, the ANDA filer must submit draft bioequivalence protocols for the product, as well as all informed consent documents and information materials that contain safety protections comparable to those in the REMS protected drug.

Once it makes a determination on the request, the FDA will assure the brand firm that the agency doesn’t consider handing over samples for bioequivalence testing to be a REMS violation, something brandmakers have warned of in past refusals. 

Generics firms have long asserted that brandmakers use REMS as a strategy to head off competition, and claims of REMS misuse have increased in recent years as nearly 40 percent of all new drugs now come with REMS protections, says GPhA. GPhA president Ralph Neas said the guidance is a helpful step in addressing the issue.

Still, one expert says the agency’s latest move may do little to ease the problem. The FDA has been issuing similar REMS letters upon request for years, said McGuireWoods attorney Brian Malkin. Brandmakers have still refused to sell their products, claiming they can choose with whom they do business, he added.

In reality, there is little the FDA can do to force brandmakers to provide product samples to their would-be generic competitors, Malkin told DID. The best options for generics firms would likely be an industrywide FTC rule or congressional action, he added.

The FTC has weighed in on an individual REMS case, with a legal brief this summer that assailed Celgene’s refusal to sell sample bioequivalence testing batches of its blockbuster cancer drugs Thalomid (thalidomide) and Revlimid (lenalidomide) to Mylan. The U.S. District Court in New Jersey has yet to issue a ruling on the case.

Congressional action also remains a possibility, with a House bill introduced in September that would bar use of REMS and similar programs as a reason not to sell sample batches.

Comments on the eight-page guidance are due by Jan. 3, 2015. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.