On April 30, the Food and Drug Administration (FDA) reversed a Policy issued by the Department of Health and Human Services (HHS) near the end of the Trump Administration that was purportedly intended to increase drug review timeline transparency. The Policy was announced in the Federal Register on January 15 and would have required FDA to annually publish:
- The date on which it filed a New Drug Application (NDA) or received an Abbreviated New Drug Application (ANDA);
- The approval date;
- The total number of days elapsed during review; and
- The number of days in excess of 180 days.
In the announcement of the reversal, FDA stated that the Policy would have required it to publish redundant information already provided to the public in reports to Congress and on its website. Additionally, FDA stated that the Policy was defectively issued because HHS did not consult with the FDA Commissioner before issuing the notice and that it did not accurately account for the time that the review period for drug applications starts.
Additionally, a table included with the Policy inaccurately referenced the drug application submission date as the beginning of the 180-day review period, which does not actually begin until an NDA or ANDA is filed or received by the agency.
FDA also explained in the reversal that NDAs are not filed until the applications are sufficiently complete to allow for a substantive review. FDA has 60 days to make such a determination. Additionally, the date of filing for a filed application is 60 days after the date FDA received the NDA. Furthermore, ANDAs are not considered received until FDA determines them to be substantially complete.
In the notice, FDA also stated that the 180-day review period is frequently extended by mutual agreement between the agency and applicants, and that review cycles for applications or supplements can be adjusted in accordance with user fee program goals. Notably, FDA highlighted its ability to meet or exceed its performance goals and its shortening of review and approval times for new and generic drugs.
This reversal was the latest in several, similar actions by the Biden Administration to undo various pronouncements from the final days of the Trump Administration. FDA also reversed a Trump-era policy which exempted seven types of surgical and patient examination gloves and proposed to permanently exempt more than 80 Class II devices and one unclassified device from premarket notification requirements.
In March, the Department of Health and Human Services (HHS) delayed implementation of the Trump administration’s “SUNSET” rule due to ongoing litigation. The rule requires that the regulations of HHS agencies, including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare and Medicaid Services automatically sunset and be rescinded unless agencies, subject to certain exceptions, perform retrospective reviews to assess the economic impact of a regulation’s requirements consistent with the Regulatory Flexibility Act (RFA) ten years after each regulation is issued. On March 9, several health groups including the American Lung Association and the Center for Science in the Public Interest joined Santa Clara County, California and other advocacy groups in a lawsuit against HHS over the Trump administration’s rule in the U.S. District Court for the Northern District of California.
