June 28 (UPI) — The U.S. Food and Drug Administration has taken two new steps to provide more lower-cost prescription drug alternatives and increase competition.
As part of the FDA’s Drug Competition Action Plan rolled out in May, the agency on Tuesday published a list of off-patent, off-exclusivity branded drugs without approved generics and implemented a new policy to expedite the review of generic drug applications in places where competition is limited.
The agency plans to expedite the review of any generic drug application for a product on the list to allow them to come to market as quickly as possible.
The FDA said it will expedite the review of generic drug applications until there are three approved generics for a given drug on the market.
“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,” FDA Commissioner Dr. Scott Gottlieb, said in a press release. “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.”
The FDA plans to unveil additional parts of the plan in the near future.
“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.
