FDA OKs first generic under new approval pathway
- The Food and Drug Administration on Wednesday made first use of a new pathway aimed at speeding review for generics of products without competition, approving Apotex's oral solution of potassium chloride for patients with low potassium levels.
- The "Competitive Generic Therapy" designation was created under the FDA Reauthorization Act of 2017 and grants applicants who successfully secure approval 180 days of market exclusivity. Any products OK'd with the new tag, however, must be commercially marketed within 75 days or the exclusivity will be forfeit.
- Under Commissioner Scott Gottlieb, the FDA has pushed to speed market entry of generics and biosimilars as part of a broader plan to boost competition and, hopefully, lower prices.
When only one generic is on a market, pricing problems can quickly emerge, sometimes dramatically.
Turing Pharma's Martin Shkreli infamously hiked the price of off-patent Daraprim (pyrimethamine), used to prevent toxoplasmosis in people with HIV/AIDS, by more than 5,000%. Other well-known examples include the sharp increases taken by Valeant on the prices on heart drugs Isuprel (isoproterenol) and Nitropress (sodium nitroprusside), and Questcor's (now Mallinckrodt) gradual 85,000% price hike of Acthar Gel (repository corticotropin injection).
Competition can rapidly push down drug prices, and second generic entry is generally associated with the large price reduction versus a reference product, according to an FDA analysis.
The aim of the Food and Drug Administration's new competitive generic therapy pathway is to prevent scenarios like that of Daraprim by encouraging generic drug development for products with inadequate competition, FDA commissioner Scott Gottlieb explained in a press release. There are currently 33 ANDAs with a competitive generic therapy designation awaiting FDA action.
"The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs," Gottlieb added.
The pathway reduces the number of review cycles that generic applications typically go through. Apotex's Abbreviated New Drug Application for potassium chloride oral solution, for example, was approved in its first cycle of review.
The Association for Accessible Medicines, the trade body for manufacturers of generics and biosimilars, lauded the approval.
"Generic manufacturers have responded to the Administration's efforts to increase competition through the new CGT pathway and remain committed to working to ensure that safe, effective and more affordable FDA-approved generics are accessible to patients and providers," said the group's CEO Chip Davis. "This pathway, created through FDARA, is a better long-term sustainable solution than considering bringing in drugs from foreign markets."
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