FDA updates generic drug policy to boost competition

The Food and Drug Administration on Tuesday published a list of brand name drugs without generic competition and implemented a policy to accelerate generic drug approvals.

The actions represent the agency's first steps to improve access to medications and lower drug costs, as outlined in the agency's Drug Competition Action Plan announced by FDA Commissioner Scott Gottlieb, MD, last month.

"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 Dr. Gottlieb.

Under the new generic drug approval policy, the FDA will accelerate the review of generic drug applications until three approved generic versions per brand name drug are on the market.

The agency also released a list, containing all brand name drugs on the market with no patents or exclusivity periods in effect and no approved generic competition. The agency hopes this document will encourage more generic drug development and plans to prioritize the review of any generic version of a drug on the list.

For more information about the FDA's actions, click here.

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