Too much REMS = Higher $$ and no generics? FTC thinks maybe.
Feel like there is too much going on with REMS these days? You are not alone. The Pink Sheet reports: "The Federal Trade Commission is looking into whether companies are using their Risk Evaluation and Mitigation Strategies to thwart generic competition." Specifically, FTC will be investigating whether companies are making the REMS so complex and expensive that they are a barrier to entry for generics.
This comes on the heels of the FDA's meeting with the generic oral transmucosal fentanyl makers (Actiq, Fentora, Onsolis, plus generics) on Thursday. Word is that FDA proposed a REMS that is similar to the severe restrictions on Onsolis, but without the specialty pharmacy bit. We'll post the FDA's draft REMS once we get a public copy. What generic company would want to launch a product where the REMS costs more than the company makes?
PATIENTS LOSE.
Playing It Too Safe?: FTC Investigating Use Of REMS To Block Generics (p. 14): The Federal Trade Commission is looking into whether companies are using their Risk Evaluation and Mitigation Strategies to thwart generic competition.
Markus Meier, assistant director of the Health Care Division in FTC’s Bureau of Competition, cited the agency’s concern about REMS abuse at an American Conference Institute meeting on “Maximizing Pharmaceutical Patent Life Cycles” held in New York City Oct. 6-7.
Meier said he had seen two ways a company may use REMS to block generics: preventing generic companies from getting samples of the drug for bioequivalence testing, or making it difficult for a generic to participate in its REMS program.
“Some systems are so restricted that there is nowhere to buy the product except to buy it from the branded company,” he said. If the branded company refuses to sell it then the generic cannot do bioequivalence testing and therefore cannot file an ANDA and “potentially there will never be generic competition for the product.”
Meier said FTC has also seen some instances in which the generic company got sufficient samples and filed an ANDA and then had to come within the branded company’s REMS to start marketing their product. At that point “the branded company tries to impose onerous requirements for participation in the program so that it makes it difficult for the generic to actually qualify,” he stated.