New FDA Policy Aims to Increase Number of Generics on Market

The Agency will expedite the review of generic applications until there are 3 approved generics for a given product
The Agency will expedite the review of generic applications until there are 3 approved generics for a given product

The Food and Drug Administration (FDA) has announced a new policy to expedite reviews of generic drug applications in cases where competition is limited.

Under the new policy—the first as part of the FDA's new Drug Competition Action Plan—the Agency will expedite the review of generic applications until there are 3 approved generics for a given product. To aid this process, the Agency also published a list of approved New Drug Application (NDA) drugs that do not have an approved corresponding Abbreviated New Drug Application (ANDA).

Drugs that are no longer protected by a patent or exclusivities will also be included in this list. The list will be updated regularly to ensure continued transparency where increased competition has the potential to provide significant benefit to patients.  

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Commenting on the motivation behind these changes, FDA Commissioner Scott Gottlieb, MD,  said, “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.” 

Drug prices are known the decrease significantly when there are multiple FDA-approved generics available. In a press release, the Agency said that this effort is the first in a number of steps they intend to take to expedite generic drug aprovals. New aspects of this effort are expected to be revealed soon. 

“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,” said Commissioner Gottlieb.

For more information visit FDA.gov.