FDA creates generic pathway for REMS medicines

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product testing.

 

"This guidance is part of the 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 agency stated. "Prospective ANDA sponsors need supplies of reference listed drugs to conduct bioequivalence and other testing to support their ANDAs." 

 

“GPhA applauds the FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs," stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. "The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors," he said. "Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales."

 

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 REMS or voluntarily by the RLD holder, the agency noted. 

 

"Because some brand-name drug companies argue that providing adequate supplies of the reference listed drug to prospective ANDA sponsors would violate their REMS, the 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 FDA sated. 

 

The FDA welcomes public and stakeholder comments to the public docket for a period of 60 days, beginning Dec. 5.