FDA Announces Revocation of Policy on Information Related to New Drug Applications

May 7, 2021Articles

On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs.

The new policy would have required the FDA to “[p]ublish 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[i]. The FDA said the policy would have caused it to publish duplicate information that it already publishes in other places, reports to Congress and posts on its website.

The FDA also said it was not notified or consulted by HHS in regards to the issuance of the new policy. Additionally, the FDA provided that the new policy did not factor in additional considerations around timing of its review of drug applications. Finally, the FDA provided that NDAs are not filed until the FDA determines whether the application is far enough along to permit a substantive review (the FDA has 60 days to do so). ANDAs also have a similar requirement around the completeness of an application.

This is one of several recent actions the FDA and HHS have taken to overturn policies the previous administration enacted near the end of its term.

If you have questions regarding this issue or other FDA issues, please contact one of Dinsmore’s Life Sciences attorneys. For more information, go to https://www.dinsmore.com/life-sciences-industry/.


[i] Federal Register, (2021, January 15) FDA Drug Review Timeline Transparency; Statement of Policy https://www.federalregister.gov/documents/2021/01/15/2021-00786/fda-drug-review-timeline-transparency-statement-of-policy