Agency promotes competition to reduce drug prices.

Characterizing the policy move as taking two crucial steps to increase competition in the market for prescription drugs, the FDA announced that it has published a list of off-patent, off-brand drugs without approved generics, and for the first time will institute a policy to expedite the review of generic drug applications when competition is limited.

According to the FDA, the action is a first for the agency’s Drug Competition Action Plan introduced by new commissioner Scott Gottlieb last May. “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,” explained Gottlieb. He also added that “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 said that posting the list is meant to encourage generic drug development and incentivize developers by identifying needed therapeutics yet to be approved via an Abbreviated New Drug Application. The Agency said it also intends to expedite the review of any generic drug application for a product on its list to ensure that they can reach the market as fast as possible. The FDA, it said, “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 actions, said FDA, follow closely behind its announcement of a public meeting, taking place on July 18th to solicit input on places where regulations and rules, “including the standards and procedures related to generic drug approvals” create obstacles to patient’s access to less expensive generics or thwart “vigorous” competition. Concluded Gottlieb, “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,” continued Commissioner Gottlieb.