FDA to Expedite Review of Some Generics

The announced change to its policy on how the agency prioritizes its review of generic drug applications means FDA will expedite the review of generic drug applications until there are three approved generics for a given drug product.

The U.S. Food and Drug Administration implemented a new policy on June 27 to expedite the review of generic drug applications where competition is limited and also published a list of off-patent, off-exclusivity branded drugs without approved generics. These actions are among the first taken under the agency's Drug Competition Action Plan announced by FDA Commissioner Dr. Scott Gottlieb in May 2017. "No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require," he said. "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."

To encourage generic drug development, FDA posted a list of branded drugs that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application and said it will expedite review of any generic drug application for a product on that list to ensure they come to market as quickly as possible. The announced change to its policy on how the agency prioritizes its review of generic drug applications means FDA will expedite the review of generic drug applications until there are three approved generics for a given drug product.

The actions follow FDA's announcement of a public meeting on July 18, 2017, to solicit input on places where its rules are being used in ways that may create obstacles to generic access. "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.

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