FDA clears an obstacle to generic drug approval applications

Relations between a brand owner and a generics manufacturer are only occasionally friendly, since the latter is bidding to compete with the former when a branded drug’s patent is scheduled to expire. Now, FDA is positioning to remove one source of friction: the difficulty of obtaining samples of the branded drug (for bioequivalence studies) in cases where a REMS (Risk Evaluation and Mitigation Strategies) was attached to the branded drug when FDA had approved it. A REMS program can have very strict requirements for how a drug is administered to a patient (such as requiring a trained provider and prior testing); brand owners had contended that they couldn’t release the drug for bioequivalence as a result. No bioequivalence, no way to complete the Abbreviated New Drug Application (ANDA) by the generic manufacturer.

In its draft guidance, FDA says that “is aware of instances in which [a patented drug owner] has refused to sell drug product to a prospective ANDA applicant seeking to conduct the testing needed to obtain approval, and the [owner] has cited the REMS” as justification—something that the Generic Pharmaceutical Assn. has contended is a “smokescreen” for anticompetitive action. Now, as long as the generic manufacturer’s ANDA incorporates the elements of the REMS program, FDA says that it will issue a letter to the brand owner freeing it from potential REMS violations. FDA also took care of its own liabilities; once the letter is issued to the brand owner, the ANDA details become public knowledge that FDA cannot hold confidentially.

“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse [REMS] programs to thwart competition from more affordable generic drugs,” the association said in a statement. The draft guidance is up for review for the next 60 days before it is finalized. At this time, there are 76 REMS programs in place, including six “shared system” REMS for multiple manufacturers of several products.