Jun 27, 2017

FDA wants to tackle drug prices by boosting generics

The FDA is taking a new swing at drug prices, announcing two new policies Tuesday that aim to boost competition from generic drugs.

  • If fewer than three generic versions of a particular drug are on the market, the FDA will "expedite" new approval requests.
  • It's also creating a new list of brand-name drugs that should be especially ripe for generic competition (products that have been around long enough to lose their temporary market protections), but don't have any. And it will also expedite the approval process for generic versions of those drugs.

Why it matters: The FDA has no direct authority over what pharmaceutical companies charge, but newly installed commissioner Scott Gottlieb has said he wants to leverage the power the agency does have — and the approval process for generics is one of its most powerful tools.

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