FDA Acts to Improve Market Competition

On June 27, 2017, FDA announced it has published a list of off-patent, off-exclusivity branded drugs that do not have generic options. The agency also implemented a new policy to expedite review of generic-drug applications for drugs where competition is limited. These steps were taken as part of the agency’s Drug Competition Action Plan. FDA hopes to increase competition in the pharmaceutical market in order to stimulate lower-cost options for consumers.

The agency’s new review policy will change how generic drugs are reviewed. The review of abbreviated new drug applications (ANDAs) for generic drugs will be expedited until there are three approved generics for a given drug product. This change is being made because of data that indicate significant price reductions are seen when there are multiple FDA-approved generic versions of branded drugs available. 

ANDAs for generic versions of drugs on FDA’s new list of off-patent branded drugs will be also be expedited. The list will be refined and updated periodically “to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.”

“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,” said FDA Commissioner Scott Gottlieb, MD, in a press release. “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.”

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