FDA Aims to Increase Rx Drug Competition & Reprioritize Generic Reviews

In its effort to increase competition in the prescription drugs market and facilitate the entry of lower-cost alternatives, today the FDA published a list of branded drugs (based on the Orange Book Data Files) that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application. The agency also launched a new policy that will reprioritize and expedite the review of generic drug applications where competition is limited. These steps are pursuant to the May 2017 announcement, by FDA Commissioner Scott Gottlieb, of the agency’s Drug Competition Action Plan.

On July 18, 2017, the FDA will hold a public meeting to solicit input on rules that stifle competition, which includes obstacles to generic medicines access.