The Food and Drug Administration is taking 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 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 in late May.
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 (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 FDA 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 the agency prioritizes its review of generic drug applications. The FDA 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, 2017, 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.