Under the new policy, FDA will expedite the review of generic drugs seeking to compete with brand name drugs that have fewer than three generic competitors on the market. FDA said it based the policy shift "on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available."
FDA on Tuesday also published a list of off-patent brand name drugs that currently do not have any approved generic competitors. FDA said the list is intended to encourage generic drugmakers to develop products to compete with the therapies. The agency added that it will update the list periodically to maintain "transparency around drug categories where increased competition has the potential to provide significant benefit to patients."
FDA said the changes are the first actions the agency has taken under its new Drug Competition Action Plan, which aims to address rising drug prices by facilitating competition in the prescription drug market.
FDA Commissioner Scott Gottlieb in a statement said he is "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" (Johnson, AP/Sacramento Bee, 6/27; Kacik, Modern Healthcare, 6/27; FDA release, 6/27).
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