FDA Announces Changes to Improve Generic Drug Options

JUNE 27, 2017
Kevin Kunzmann

The US Food and Drug Administration (FDA) has announced 2 new steps in their effort to increase prescription drug market competition while improving the opportunity of lower-cost alternative medicines.

The administration published a list of off-patent, off-exclusivity branded drugs without approved generics on Tuesday. It also implemented a first-time policy that will expedite the application review for limited-competition generic drugs. 

The efforts to provide generic options at a faster rate are among the first taken under FDA commissioner Scott Gottlieb's announced Drug Competition Action Plan in May. Gottlieb said no patient should be priced out of needed treatment, and it is the FDA's responsibility to help provide access.

"Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options," Gottlieb said.

The FDA's posted list of branded drugs without patents or exclusitivies is intended to encourage drug development, according to the administration. It intends to continuously refine and update the list as pharmaceutical developments occur.

Regarding the expedition of review for limited-competition generic drug applications, the FDA will uphold a more swift and efficient process under there are 3 approved generics for a given drug product. This decision was based on data indicating patients see significant cost reducations when there are multiple FDA-approved generics in the market.

“I am committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” Gottlieb said.

A press release regarding the changes has been made available.

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