FDA Pulls Trump Administration Policy on Drug Review Transparency

May 5, 2021

The FDA has withdrawn a Trump era policy aimed at improving transparency by requiring the agency to publish more information on drug review timelines.

HHS, which announced the policy in the last week of the Trump administration, would have made the FDA publish the date the agency received an Abbreviated New Drug Application (ANDA), the date it approved an NDA or ANDA, the amount of time elapsed between receipt of an application and approval, and the total number of days elapsed if a review exceeded the 180-day review period mandated by Congress.

In withdrawing the policy, the FDA said the agency “did not find any evidence that HHS consulted with, otherwise involved or even notified [the] FDA before issuing the notice.”

The agency also noted that it currently publishes monthly metrics online that include the number of applications approved or tentatively approved along with quarterly reports, making the new HHS publishing rule “redundant.”

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