> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# HHS Overreach Renews Calls for Independent FDA
- URL: https://www.fdaweb.com/hhs-overreach-renews-calls-for-independent-fda/
- Published: 2021-01-22T12:00:00.000Z
- Updated: 2026-09-14T16:43:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148506

HHS’s unprecedented overreach during the Trump Administration has drawn increased interest in making FDA an independent agency. “The durability and long-term effects of the department’s changes to FDA policy and its actions to limit the agency’s autonomy remain in question, but the public conversation about independence, public trust, and scientific integrity will continue,” a 1/21 [Sidley law briefing](https://www.sidley.com/en/insights/newsupdates/2021/01/briefing-fda-autonomy-in-the-biden-administration?ref=fdaweb.com) says.  

HHS interference is nothing new at FDA, but it appears to have escalated during the Trump Administration, according to Sidley attorneys. During the Obama presidency, HHS was very involved in the decision to switch the contraceptive product Plan B to partial nonprescription status, and during the George W. Bush administration the HHS Secretary articulated a “One HHS” policy, “which included a range of internal actions to limit FDA’s autonomy such as recasting the FDA Office of the Chief Counsel (OCC) as fully within the Office of the Secretary and requiring OCC review of all Warning Letters issued by FDA offices,” the briefing notes.

During the Trump Administration, FDA watchers saw an increased level of concern over HHS’s involvement in agency policy matters. According to the Sidley briefing, “HHS reversed highly significant FDA policies affecting clinical laboratories and drug and medical device developers. Under the department-wide ‘Regulatory Reform Initiative,’ HHS also consolidated decisionmaking in political appointees, altered federal civil service protections, and dramatically limited FDA’s rulemaking and guidance development authority. And in the last week of the Trump Administration, [HHS reversed](https://www.fdaweb.com/fda-hhs-play-musical-chairs-with-chief-counsel-post/) FDA’s acting chief counsel pick; issued a policy requiring FDA to annually publish the number of days required for approval of new drugs beyond the statutorily-required 180 days and [exempted seven categories](https://www.fdaweb.com/hhs-steps-on-fdas-feet-to-advance-2-policies/) of Class 1 medical devices from premarket review and proposed to exempt 84 other generic types of devices; and pushed forward a rule requiring performance appraisals for career scientists within FDA and the other HHS operating divisions every five years. “Regardless of the perceived merits of any of these decisions, such a level of involvement in FDA decisions by department-level officials is highly unusual,” the briefing says.

The Sidley briefing notes that regulatory actions taken at the end of any Administration are typically reversed under a “regulatory freeze” memorandum, which was issued on inauguration day. “Actions taken by HHS that did not involve rulemaking — including the reversal of the long-standing FDA policies on laboratory developed testing and the unapproved drugs initiative — are not subject to the regulatory freeze, but could be reversed in reliance on separate agency powers,” it says, adding that executive orders can also be revoked at any time.