By: T. Daniel Logan
On December 7, 2020, the Department of Health and Human Services (HHS) published a rulemaking that formally adopts Good Guidance Practices (GGPs) across the Department. Department of Health and Human Services Good Guidance Practices, 85 Fed. Reg. 78,770 (Dec. 7, 2020). The rules, which will be codified at 45 C.F.R. Part 1, will govern the procedures and requirements that HHS component agencies seeking to publish guidance must follow. Notably, the Food and Drug Administration (FDA), a component of HHS, has its own GGP regulations, which were adopted two decades ago to comply with the requirements of the Food and Drug Administration Modernization Act of 1997. See 21 C.F.R. § 10.115. While HHS and FDA have adopted regulations that are not coextensive with each other in the past,[1] here, the preamble to the HHS final rule directly addresses the potential conflict with FDA’s GGPs, explicitly stating that “FDA must comply with all requirements implemented in this HHS Good Guidance Practices final rule.” 85 Fed. Reg. at 78,771.[2]
If FDA already has its own, statutorily mandated GGPs, what is the purpose of subjecting FDA to the HHS rule? This alert examines the key points of the HHS rule and considers the implications for FDA.
“Guidance Document” and “Signifiant Guidance Document”
HHS and FDA regulations differ at the outset, offering contrasting approaches to defining which agency documents would constitute “guidance” for the purpose of GGPs.
The HHS regulations state that a “guidance document” is “any Department statement of general applicability, intended to have future effect on the behavior of regulated parties and which sets forth a policy on a statutory, regulatory, or technical or scientific issue, or an interpretation of a statute or regulation.” 45 C.F.R. § 1.2. Excluded from the definition are agency rulemakings, rules of agency organization, procedure, or practice, internal guidance not intended to have an effect on outside parties, decisions of adjudications, and similar documents. A guidance document is “significant” if it could “reasonably be anticipated” to have an annual economic effect of $100 million or more or an adverse impact on the economy, environment, or public health, or if it could “create a serious inconsistency or otherwise interfere” with agency actions (planned or taken) or “raise novel legal or policy issues arising out of legal mandates,” “the President’s priorities,” or Executive Order 12866, among other factors. Id.
Unlike the HHS regulations, FDA’s GGP regulations do not attempt to define “guidance document,” but instead offer a we-know-it-when-we-see-it approach that provides examples of types of documents that are and are not guidance. 21 C.F.R. § 10.115(b). FDA then bifurcates guidance into “Level 1” and “Level 2,” with the former being those documents that set forth initial interpretations of statutory or regulatory requirements, set forth changes in interpretation or policy that are of more than a minor nature, include complex scientific issues or cover highly controversial issues. 21 C.F.R. § 10.115(c)(1). Level 2 guidance includes everything else and generally set forth “existing practices or minor changes in interpretation or policy.” 21 C.F.R. § 10.115(c)(2).
The HHS definition of guidance appears to be broader than FDA’s definition and gives FDA less leeway to proactively determine that a document would not constitute guidance. For example, the preamble of the HHS rule states that social media posts could fall under the definition of guidance. 85 Fed. Reg. at 78,773. Similarly, HHS’s definition of “significant guidance” suggests that politics should play a larger role in development of guidance. For instance, it would seemingly be impossible for component agencies to determine whether proposed guidance “conflicts with the President’s priorities” without consulting political higher-ups.
Procedural and Political Controls on Guidance Development
Where FDA’s GGPs require a notice in the Federal Register announcing the availability of and inviting comments on “Level 1” guidance, the HHS rule subjects such guidance to a process more akin to rulemaking. 21 C.F.R. § 10.115(g)(1). “Significant guidance” must be: 1) approved, on a non-delegable basis, by the Secretary; 2) submitted to the Office of Information and Regulatory Affairs (OIRA) for review; and 3) be published in the Federal Register with a 30-day comment period (unless good cause exists). 45 C.F.R. § 1.3(b). Agencies then must “publish a public response to the major concerns raised…” Id. Further, economically significant guidance must now be accompanied by a separate Regulatory impact Analysis (RIA). Id. Whereas FDA could opt to immediately implement “Level 1” guidance if public comment was not “feasible or appropriate,” the HHS regulations allow the procedure to be circumvented only if the Secretary of HHS and the Administrator of OIRA agree that an exemption is warranted. This procedure would place significant hurdles in the path of expedient guidance development by FDA.
Similarly, where FDA’s regulations permitted the publication and immediate implementation of “Level 2” guidance, 21 C.F.R. § 10.115(g)(2), the HHS rules require the Secretary of HHS to approve, on a non-delegable basis, any documents that the Secretary determines will “[i]mplicate, including potentially impede, any policy matter of priority to the Secretary” or “[p]otentially create a serious inconsistency, or otherwise interfere, with an action taken or planned by another operating division or the Office of the Secretary.” 45 C.F.R. § 1.3(a). The HHS rule subjects even minor guidance to review by the Secretary, further emphasizing the politicization of less consequential agency actions.
Petition for Review of Guidance Documents
The HHS rule would require the creation and administration of a repository of guidance documents.[3] It would further enable any interested party to petition for the withdrawal or modification of a guidance document. 45 C.F.R. § 1.5(a). The agency then has 90 days to respond to any petition and any response must agree or disagree with the petition, unless the agency requests more information or determines it must consult with other stakeholders. 45 C.F.R. § 1.5(d). Agency responses must agree or disagree with the petition, state the agency’s rationale, and be posted publicly. 45 C.F.R. § 1.5(e). The requirement that agency responses address the substantive issues in a petition, with a tight turnaround time, hint at the potential for a substantial drain on agency resources should numbers of individuals take advantage of the petition process.
Implications for FDA
By instituting procedural controls that differ from current FDA requirements, increasing political review of guidance on a non-delegable basis, and instituting a potentially onerous guidance petition process, the HHS GGPs, if fully implemented, have the potential to ossify guidance development at FDA. Such a slowdown could make the FDA less able to adopt new guidance or revise older guidance to respond to changing technologies, markets, or research. The GGPs also represent a clear step to remove some of FDA’s autonomy from HHS.
However, there are two possible reasons to believe that the HHS GGPs may not change FDA’s current practices. First, the HHS GGPs are scheduled to take effect on January 6, 2021, less than two weeks prior to the administration change. 85 Fed. Reg. at 78,770. A new administration could withdraw or modify the HHS GGPs through rulemaking. Second, the preamble of the HHS regulation clarifies that FDA would only be subject to the HHS regulations until FDA’s own GGPs are amended to conform to the requirements of Executive Order 13891 (which, among other things, requires agencies to promulgate procedures for adopting guidance documents).[4] 85 Fed. Reg. at 78,771. A new administration could withdraw this Executive Order, which would render moot the need for FDA to amend its GGP regulations. Accordingly, application of the HHS GGPs to FDA may be temporary – but the immediate implications of such GGPs remains to be seen.
[1] For instance, HHS and FDA have separate rules regarding treatment of agency records under the Freedom of Information Act. See 45 C.F.R. Part 5 (HHS); 21 C.F.R. Part 20 (FDA).
[2] While HHS initially proposed to exempt FDA from the rule’s coverage, it changed its position in the final rule in response to a comment urging HHS to include FDA. 85 Fed. Reg. at 78,771.
[3] FDA already has a guidance repository accessible at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
[4] Given that this executive order was issued by the outgoing administration, it is likely to be rescinded by the incoming administration.