Pharmaceutical companies may be in for a more difficult time hiding behind a Risk Evaluation and Mitigation Strategy (REMS) as a way to prevent generic competition from entering the market.
The Food and Drug Administration issued two draft guidance documents on May 31 aimed at spurring on generic competition, items that are part of a broader White House strategy targeting the high price of prescription drugs.
“We have seen REMS requirements exploited in two ways,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “One occurs at the front end of the drug development process, when generic drugs are being developed. The other occurs at the back end of the process, after necessary testing has been completed, when a generic drug seeks approval and market entry.”
On the front end, manufacturers use REMS to restrict the sale of drugs to keep them out of the hands of generic firms, which typically need about 5,000 doses to conduct bioequivalence and bioavailability studies, Dr. Gottlieb noted. The back-end obstacle, which happens after a generic manufacturer files application for generic approval, is what the two guidance documents address.
The first draft guidance, “Development of a Shared System REMS,” outlines principles and recommendations for brand and generic manufacturers to develop a single REMS program that covers both products, which Dr. Gottlieb said will “enable timelier market entry for products that are part of these REMS.”
The second draft guidance, “Waivers of the Single Shared System REMS Requirement,” describes the two circumstances under which the generic manufacturer can waive the single, shared REMS requirements:
- If the burden of forming a single, shared systems outweighs the benefits.
- If an aspect of the REMS is covered by a patent or is a trade secret and the generic company was unable to obtain a license for use.