WASHINGTON — The Food and Drug Administration today announced two new steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.
These actions are among the first taken under the agency’s Drug Competition Action Plan, announced by commissioner Scott Gottlieb in late May.

Scott Gottlieb

“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 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.”

The actions were hailed by the Association for Accessible Medicines (AAM). “FDA commissioner Scott Gottlieb’s swift and decisive action to expand access to safe, effective and affordable generic and biosimilar medicines is of tremendous benefit for our nation’s patients,” said Chester “Chip” Davis, Jr., president and CEO of AAM. “Today’s announcement signals that any serious effort by the Trump administration or the United States Congress to bring down drug costs for patients must include more affordable generics and biosimilars. AAM looks forward to working with FDA and policy makers on all possible ways to further enhance competition and improve the first cycle approval rate for generic drug applications.”

To encourage generic drug development, the 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 (known as an Abbreviated New Drug Application or ANDA). The agency 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 also announced a change to its policy on how it prioritizes its 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 agency is revising the policy based on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available.

These actions follow closely the FDA’s announcement of a public meeting to be held on July 18 to solicit input on places where the FDA’s rules — including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended.

“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,” said Gottlieb.

These are the first of a series of steps the agency intends to take to help tackle this important issue. The agency will unveil additional aspects of this plan in the near future and will continue to communicate with the public as additional elements of this plan are implemented.