We were promised “radical transparency” by the incoming Secretary of HHS.  We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.”  Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself.  For one thing, as we mentioned most recently here, the FDA takes notice and comment on guidance documents, such as those it issues that concern off-label speech.  As we’ve pointed out many times, guidance documents are not regulations with force of law.

The new-look HHS (of which the FDA is a part) evidently doesn’t want to be bothered with what the public – which frequently includes our clients − thinks any more than it has to under the APA.  Recently, HHS published a notice in the Federal Register that henceforth regulatory notice and comment will be limited to the APA’s statutory requirements.  See “Policy on Adhering to the Text of the Administrative Procedure Act,” 90 Fed. Reg. 11029 (HHS March 3, 2025).  As HHS points out in its policy statement, the APA only requires “rule making” to include public notice and comment:

(a) This section applies, according to the provisions thereof, except to the extent that there is involved . . . .

(2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.

(b) . . . Except when notice or hearing is required by statute, this subsection does not apply −

(A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or

(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.

5 U.S.C. §553(a-b).

The Richardson waiver did not deal with all these statutory exemptions, only those in §§335(a)(2) and (b)(4)(B).  Here’s what the original 1971 notice stated:

Effective immediately, all agencies and offices of the Department which issue rules and regulations relating to public property, loans, grants, benefits, or contracts are directed to utilize the public participation procedures of the APA.  Although the APA permits exceptions from these procedures when an agency for good cause finds that such procedures would be impracticable, unnecessary or contrary to the public interest, such exceptions should be used sparingly, as for example in emergencies and in instances where public participation would be useless or wasteful because proposed amendments to regulations cover minor technical matters.

36 Fed. Reg. at 2532 (emphasis added).

The current department head, however, believes that “[t]he extra-statutory obligations of the Richardson Waiver impose costs [that] are contrary to the efficient operation of the Department, and impede the Department’s flexibility to adapt quickly to legal and policy mandates.”  90 Fed. Reg. at 11029.  HHS thus appears poised to follow the APA’s limitations on notice and comment rulemaking to the letter:

The policy waiving the statutory exemption for rules relating to public property, loans, grants, benefits, or contracts is contrary to the clear text of the APA and imposes on the Department obligations beyond the maximum procedural requirements specified in the APA.  The text of the APA recognizes that it is necessary and appropriate to issue rules relating to agency management or personnel or to public property, loans, grants, benefits, or contracts without notice and comment procedures.  It also is contrary to the clear text of the APA to use the good cause exception “sparingly.”

Id.  Thus, “[e]ffective immediately,” the Richardson waiver is no more.  Specifically, there will be no more notice and comment for “matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” which “are exempt from the notice and comment procedures.”  Id.

We’re not sure what this means for the previous practice (of the FDA, at least), of opening items within the §355(b)(4)(A) exception – such as the guidance documents mentioned earlier – which were outside of both the Richardson waiver and (apparently) the March 3, 2025 notice.  Given the general hostility that the notice exhibits to extra-statutory public access, we are not optimistic that any notice and comment not absolutely APA required will be permitted.  As far as litigation impact is concerned, both sides of the “v.” have weighed in when their perceived interests were impacted.  On the whole, however, we have the sense that industry, or industry groups such as the Medical Information Working Group, has participated to a greater degree than the other side.

Certainly, however, HHS will now be acting on the items specifically listed in the March 3 notice:  “agency management or personnel or to public property, loans, grants, benefits, or contracts without notice and comment procedures.”  90 Fed. Reg. at 11029.  This gives us considerable pause.  FDA frequently enters into contracts with prescription medical product manufacturers, such as the vaccine contract recently in the news.  Going forward, all these contracts seem subject to change or revocation without prior notice.  The exception for “agency management or personnel” also concerns us.  For example, does this mean that the CDC could, without prior notice, simply abolish – or replace all the members of – the Advisory Committee on Immunization Practices (“ACIP”), which has overseen the list of vaccines covered by the Vaccine Act, 42 U.S.C. §300aa-10 et seq., since that statute was enacted.  Because the Vaccine Act preempts most state tort liability for the vaccines on that list, such an upheaval would directly impact prescription medical product liability litigation. Within the FDA itself, does “personnel” mean the summary dismissal of any drug (say, mifepristone, or perhaps Ritalin) reviewer who refuses to ignore scientific evidence and force a product off the market for political reasons? We don’t know, but once again, this development is disturbing.