HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

At a Glance

• A critical question that now arises is: Will HHS Secretary Kennedy’s rescission of the Richardson Waiver allow the FDA to impose additional legal requirements on industry by way of the more public-facing internal processes and operating procedures that the FDA has traditionally published using good guidance practice?
• Without notice-and-comment rulemaking, HHS agencies can use operational process documents applicable to FDA management and personnel in ways that affect the rights of industry, or otherwise significantly alter FDA policy, without going through long-established informal rulemaking procedures.
• In the absence of due procedural protections, the FDA and agencies like it may now be in a position to broadly interpret statutory law and implement additional regulatory requirements while, at the same time, denying the public and regulated industry advanced notice and opportunity to comment.

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written in 1971, the Richardson Waiver forgoes the Administrative Procedure Act’s (APA) statutory exemption from procedural rulemaking requirements for any rules and regulations relating to “agency management and personnel” or to “public property, loans, grants, benefits, or contracts” in the absence of good cause (5 U.S.C. § 553(a)(2)).

In accordance with the Richardson Waiver, the rule of thumb of the U.S. Food & Drug Administration (the FDA) has been to follow good guidance practice — i.e., forgoing 5 U.S.C. § 553(a)(2)’s exemption of notice-and-comment rulemaking — for these types of matters.

While this rescission may sound innocuous since the APA exemption of notice-and-comment rulemaking was intended to be used “sparingly” for emergencies or “where public participation would be useless or wasteful” (36 Fed. Reg. § 2532), it may prove quite consequential.

A critical question that now arises is: Will HHS Secretary Kennedy’s rescission of the Richardson Waiver allow the FDA to impose additional legal requirements on industry by way of the more public-facing internal processes and operating procedures that the FDA has traditionally published using good guidance practice?

Processes and Procedures Affecting Industry Rights Without Meaningful Opportunity to Comment?

Based on the lead author’s experience at the FDA, it becomes apparent how impactful this rescission may be for industry. In the author’s 15 years at the FDA as a regulatory counsel, one of her responsibilities was to review documents, such as internal standard operating procedures, to make sure the content was appropriate for the communication mechanism used — e.g., to ensure that the Center for Drug Evaluation and Research’s (CDER) core operating documents, such as Compliance Programs (CPs), Compliance Policy Guides, sections of the Regulatory Procedures Manual, and related Manual of Policies and Procedures (MaPPs) and job aids, did not contain directives to staff that were de facto requirements on industry. With the new HHS policy, she questions whether processes and procedures will be published by the FDA without giving industry a meaningful opportunity to comment, notwithstanding that CPs and other communications documents may contain directives that significantly affect regulated industry.

Hypotheticals shed light on the power held by the FDA that may now be beyond the protective reach of notice-and-comment rulemaking. For instance, the FDA could implement a Compliance Program directing investigators to collect copies of parking lot security videos as corroborating evidence that a signatory on a lab sheet did arrive at his employer’s facility on the right date, and that his car remained in the lot during the time slot at issue, thus proving that it was possible for him to have been present and able to sign and date a particular process step.

In fact, in researching this client alert, it seems this is no longer a hypothetical; the FDA level 2 (question-and-answer format) guidance on electronic signatures in clinical investigations, published in December 2024, begins to acknowledge this current FDA policy in the response to Q26 on how signatories’ identities may be verified: “Part 11 regulations do not specify a particular method for verifying the identity of the individual who will be electronically signing records. Methods for verifying an individual’s identity may include, but are not limited to, use of official Government-issued identification, security questions, or strong digital login credentials accompanied by multi-factor authentication or video observation.” Section 704 of the Federal Food, Drug and Cosmetic Act (FD&C Act) houses the FDA’s authority in this regard, explaining in great detail the nature and decisively limited extent of this codified exception to the Fourth Amendment’s prohibition against warrantless search and seizure, a carve-out provided to protect public health by enabling effective oversight of regulated industry. The rescission of the Richardson Waiver may eliminate the ability to question the FDA’s broad interpretation of Section 704 of the FD&C Act as providing FDA the authority to require industry to provide access to and copies of their parking lot security videos as supplemental evidence bearing on the question of compliance in addition to more proximate positive evidence, such as electronic access card data and digital login records.

Section 704 also specifies who may conduct an inspection (only credentialed investigators) and the kinds of records and data to which an investigator can demand access during or prior to the inspection.

Generally speaking, credentialed FDA investigators are employees within the Office of Inspections and Investigations (OII, previously the Office of Regulatory Affairs). The author’s experience at the FDA includes participating in strategy sessions on how CDER could have OII allow CDER subject-matter experts (SMEs) to attend inspections “alongside” credentialed investigators via electronic platforms. CDER SMEs, however, do not have the credentials that Section 704 requires as a prerequisite for an FDA investigator to be authorized, without a warrant, to enter and conduct a compliance inspection of a facility. After rescission of the Richardson Waiver, it is conceivable that industry could be required to allow FDA staff, who do not have investigator credentials, to enter their facilities by virtue of directions provided in a Compliance Program or other follow-on internal policies — e.g., instructing investigators to bring non-credentialed CDER SMEs with them on facility inspections, virtually or otherwise, or requiring a non-credentialed SME to attend the entirety of each inspection “alongside” the credentialed investigator and to ensure that the credentialed investigator shows the SME live shots of each manufacturing step, testing process, etc.

In Conclusion

HHS’s rescission of the Richardson Waiver may notably alter the rulemaking landscape for the health care industry. Without notice-and-comment rulemaking, HHS agencies can regulate management and personnel through operational process documents in ways that affect the rights of industry, or otherwise significantly alter FDA policy, without going through long-established informal rulemaking procedures. In the absence of due procedural protections, the FDA and agencies like it may now be in a position to broadly interpret statutory law and implement additional regulatory requirements while, at the same time, denying the public and regulated industry advanced notice and opportunity to comment.