FDAAA Impact Analysis (Year 4): The REMS Retreat Continues, But For How Long?
This article was originally published in Pharmaceutical Approvals Monthly
As the fifth year of the REMS era begins, FDA is imposing mandatory programs less frequently than it did even in the first year after the law creating formal risk management plans took effect. But there are some new trends to watch, including the evolution of REMS classes and the emergence of products with REMS-in-waiting.
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Corcept’s NDA for the controversial agent mifepristone in Cushing’s syndrome required that FDA balance the needs of prospective patients with a severe orphan disease with the desire to preserve the drug’s REMS for abortifacient use as Mifeprex. FDA’s decision to forgo a REMS was grounded on principle, precedent, and assessment of real-world likelihood of off-label use – and vetted all the way to the CDER director.
FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.
Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change? A Risk Evaluation & Mitigation Strategy that will be precedent setting if approved—and that demonstrates the power of REMS even if FDA moves in a different direction with this application.