REMS, FDA, FDAAA, FTC, ANDA ...
The Federal Trade Commission is looking into whether companies are using REMS to thwart generic competition.
Markus Meier, assistant director of the Health Care Division in FTC’s Bureau of Competition, 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.”
Hm. “Spirit” of FDAAA notwithstanding, can a company be “forced” to sell its product to a competitor? Interesting IP question.
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.
Hm. But don’t all REMS have to be approved by the FDA? Minus more directive practices from the agency, well, if you’re not part of the solution …
“I’m not saying that’s been proven,” Meier added. “I’m not saying we’ve made that accusation of anybody but we’re looking at it. And one of the reasons we’re looking at is because the statute (FDAAA) expressly prohibits participants in these programs from using REMS to erect barriers to competition.”
As for dealing with potential REMS abuse, Meier said FDA does not believe it has any mechanism to enforce the FDAAA provision prohibiting a company from using a REMS to block or delay approval of an ANDA. But “onerously prescriptive” is certainly in the eyes of the beholder. Is a REMS that’s tough for the proper public health reasons somehow wrong if it restricts entry of a generic and/or follow-on product?
Certainly not.