FDA takes major step to lower insulin prices
FDA is advancing major new policies to lower insulin prices in the United States.
In a statement published on April 2, 2019, FDA announced plans to transition certain biological products—including the diabetes medication insulin—that have been historically regulated as conventional drugs (a.k.a. small-molecule drugs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be regulated as biologics under the Public Health Service Act (PHS Act). PHS Act typically regulates FDA approval of most biologic drugs.
FDA explained that this transition will allow biosimilar insulin products and substitutes to come to market for the first time, stimulating competition and hopefully lowering the drug’s prices.
The price of insulin has been a pressing issue in public minds, especially among patients with diabetes, pharmacists, and physicians. While the medication has been around for nearly a century, its price continues to skyrocket by double digits annually.
These soaring prices are due in part to a lack of effective competition in the market for insulin products and biosimilar substitutes. Until recently, insulin and other biologic drugs did not have an “abbreviated pathway for bringing follow-on versions to market under the PHS Act,” according to the statement. This changed with the 2010 Biologics Price Competition and Innovation Act through which Congress authorized FDA to open biologics regulated under the PHS Act to competition.
FDA will hold a public hearing on May 13, 2019, to discuss this transition and the unique challenges the introduction of competitive insulin products may bring. The agency hopes to gain feedback from stakeholders and patients alike regarding different factors it should consider as it works to build a “solid regulatory foundation for the review and approval” of these products. FDA added that the input from the hearing will also help to inform the agency on further steps it can take to make high-quality, affordable insulin options more accessible to the public.
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