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FDA scraps another last-minute Trump-era policy

Posted 30 April 2021 | By Michael Mezher 

FDA scraps another last-minute Trump-era policy

The US Food and Drug Administration (FDA) on Friday revoked a policy issued in the final days of the Trump administration that was purportedly aimed at increasing transparency related to drug review timelines.
The policy, announced by the Department of Health and Human Services (HHS) on 15 January 2021, would have required FDA to publish “redundant” information on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the agency for review.
The move is the latest in a series of actions FDA and HHS have taken to walk back last-minute policies the previous administration issued on its way out. (RELATED: HHS pushes through last-minute policies impacting FDA, Regulatory Focus 12 January 2021; HHS hits pause on Trump era SUNSET rule, Regulatory Focus 22 March 2021; FDA walks back Trump-era premarket notification exemptions, Regulatory Focus 15 April 2021).
Specifically, the policy called on FDA to publish the date on which an NDA was filed or an ANDA was received, the date of approval, total time elapsed during review and the total number of days in excess of 180 days. The 180-day timeframe refers to the amount of time allotted to FDA to review new drugs, from the date of filing to FDA’s decision date, under the Drug Amendments of 1962.
In pulling the plug on the policy, FDA said the policy would have required it to publish redundant information as it already publishes information on its drug review performance in reports to Congress and on its website and that the policy was pushed through without the agency’s input.
“We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing this notice,” FDA wrote. While HHS is tasked with overseeing FDA and executing the Federal Food, Drug, and Cosmetic Act, it is required to do so “through the [FDA] Commissioner.”
FDA also wrote that the policy “did not account for all relevant considerations related to the timing of FDA’s review of drug applications. The statement of policy did not accurately account for the time that the review period for drug applications starts.”
“Although the table of drug approvals presented in the Statement of Policy … references the drug application submission date as the beginning of a 180-day review period, the review period does not actually start until a drug application is ‘filed’ or ‘received’ by FDA,” the agency noted.
FDA further explained that NDAs are not filed until it determines that the application is sufficiently complete to permit a substantive review, which it has 60 days to do, and that the date of filing for a filed application is 60 days after the date FDA received the NDA. Similarly, for ANDAs, an application is not considered received until FDA determines it to be substantially complete.
FDA also pointed out that the 180-day review period is often extended by mutual agreement between the agency and applicant, and that “since the enactment of the Prescription Drug User Fee Act of 1992 (PDUFA), there has been a mutual understanding between industry and the Agency that the review cycle for an application or supplement subject to user fees may be adjusted (either shortened or lengthened) in accordance with the user fee performance goals,” as is the case under the Generic Drug User Fee Amendments (GDUFA).
Under the two user fee agreements, FDA said it “regularly meets or exceeds” its review performance goals and that it has reduced review and approval times for both new and generic drugs.


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Tags: drugs, FDA, US

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