FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Publishes List of Generic-Ready NDAs, as Action Plan to Boost Competition Takes Shape

June 30, 2017
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The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the first steps in the agency’s action plan to help lower the costs of prescription drugs.

The FDA will expedite the review of ANDAs until there are at least three generics approved for a given reference drug, based on data linking significant price reductions to the availability of multiple generic options. The agency has not received ANDAs for about 10 percent of brand-name drugs whose patents and exclusivity protections have expired.

“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 Commissioner Scott Gottlieb in a statement, adding that the agency should become more risk-based in its work, and make sure the FDA’s regulations aren’t being used to delay competition.

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