FDA Issues Parts of Drug Competition Action Plan

As part of the US Food and Drug Administration’s (FDA) Drug Competition Action Plan that was announced by FDA Commissioner Scott Gottlieb in late May, the FDA has taken two actions that seek to increase competition and improve access to generic drugs. The agency has published a list of off-patent, off-exclusivity branded drugs without approved generics and has implemented a new policy to expedite the review of generic-drug applications where competition is limited.

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 (i.e., an abbreviated new drug application). The agency said it 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 said 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 benefit to patients.

The FDA also announced a change to its policy on how the agency prioritizes its review of generic-drug applications. The FDA said it will expedite the review of generic-drug applications until there are three approved generics for a given drug product. The agency said it 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 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 access to generic drugs. 

“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 Commissioner Gottlieb in a FDA statement.

The FDA said it will unveil additional aspects of the Drug Competition Action Plan in the near future and will continue to communicate with the public as additional elements of this plan are implemented.

Source: FDA

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