FDA Announces New Rules Designed to Increase Drug Market Competition

the agency has announced a new policy to expedite the review odf generic drug applications where competition is limited

FDA Announces New Rules Designed to Increase Drug Market Competition
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July 11, 2017

The U.S. Food and Drug Administration (FDA) has announced that it is taking two new steps designed to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.

The agency has published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented a new policy to expedite the review of generic drug applications where competition is limited.

"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," said FDA Commissioner Scott Gottlieb. "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."

Encouraging generic drugs

The list of off-patent, off-exclusivity branded drugs without approved generics has been published to encourage generic drug development. The FDA also intends to expedite the review of any generic drug application for a product on this list to ensure that they come to market as expeditiously as possible. The agency will continue to refine and update the list periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.

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

The FDA will hold a public meeting on July 18, 2017 to solicit input on the new proposed rules.

"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," noted Gottlieb.