The FDA is taking two new steps to increase competition in the market for prescription drugs and to facilitate the entry of lower-cost alternatives. The agency has published a list of off-patent, off-exclusivity branded drugs without approved generics and has 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 FDA Commissioner Scott Gottlieb, MD, in late 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,” Gottlieb 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, 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 (ANDA). The agency also intends to expedite the review of generic drug applications for products on this list to ensure that they come to market as quickly as possible. The FDA says it 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 is also announcing 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 its policy based on data that indicate that consumers see significant price reductions when several FDA-approved generics are available.
These actions follow the FDA’s announcement of a public meeting to be held on July 18 to solicit input on places where the agency’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 competition that 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,” Gottlieb added.
The agency says it will unveil additional aspects of this plan in the near future.
Source: FDA; June 27, 2017.