Industry advises FDA not to issue more guidances without public comment

Industry groups are pouring cold water on the US Food and Drug Administration’s suggestion that it might issue more guidance documents for immediate implementation, before stakeholders can provide comments.

In January 2024, FDA issued a Draft Report and Plan on Best Practices for Guidance that outlined that agency’s intention to consider issuing more Level 1 guidance documents for immediate implementation, without the typical notice and comment period, and to consider whether more guidances should be categorized as Level 2. (RELATED: FDA considers issuing more final guidances without comment period, Regulatory Focus 5 January 2024)

Level 1 guidance documents, which typically require public comment before implementation, involve initial interpretations of a statute or regulation, changes in interpretation of policy, or address complex or controversial issues. Level 2 guidance documents, on the other hand, typically involve descriptions of existing practices or minor policy changes and provide for public comment upon implementation.

Benefits of public participation

The Pharmaceutical Research and Manufacturers of America (PhRMA) and several industry groups objected to issuing more Level 1 guidances without prior public comment, emphasizing the importance of public participation in guidance development.

“Although we agree with FDA that there is reason to reflect on the [good guidance practices] lessons from the pandemic, we encourage FDA to recognize that the circumstances were extraordinary and the exceptions that were invoked during that time should not be adopted as the Agency’s general manner of practice, lest it erode FDA’s exemplar practices for guidances,” PhRMA commented.

PhRMA urged FDA to continue its current practice of issuing Level 1 guidances in draft form and seeking public comments before implementing a final version of the guidance. PhRMA agreed that there are circumstances where an exception to the notice and comment period for Level 1 guidance would be appropriate, such as protecting public health or as a response to a court order, but urged FDA to keep these exceptions narrow and allow adequate time for sponsors to adjust their processes.

The Advanced Medical Technology Association (AdvaMed) agreed that limiting the opportunity for public comment on guidance documents could undermine policymaking. The commenting process provides insights into how the policy will impact patients, industry, and public health, and helps to make sure that the guidance is understood by stakeholders, the group wrote. “Comments often present the ‘real world’ concerns of, feedback from, and examples from, those affected by the policy and enable the Agency to incorporate diverse stakeholder feedback prior to the final policy to ensure the robustness of the final guidance,” AdvaMed commented.

In cases where FDA does not provide an opportunity for comment, AdvaMed urged the agency to provide a detailed justification for doing so and present it in a standardized format and location.

The Medical Imaging & Technology Alliance (MITA) also objected to issuing Level 1 guidance without providing an opportunity for public comment, noting that while it may streamline the guidance development process, it “does not match the expectations and needs of regulated industry.” Similarly, MITA criticized FDA’s proposal to consider whether more guidance documents could be handled as Level 2 guidance, allowing them to be implemented immediately.

“Classifying additional categories of guidance as Level 2 essentially has the same effect as issuing a Level 1 guidance for immediate implementation,” MITA commented.

FDA’s draft report on guidance notes that even if Level 1 guidance were immediately implemented, there would still be a public comment period after implementation. However, MITA notes that the report does not go into detail on how FDA would consider the comments and under what circumstances the agency would revise the guidance based on comments.

“In addition to better defining scenarios that would be appropriate for immediately implementing guidance, MITA recommends that FDA generally describe when and how comments will be considered after such guidance is issued,” MITA commented.

The International Pharmaceutical Excipients Council of the Americas (IPEC–Americas) advised FDA not to expand its policy of implementing Level 1 guidance document prior to public comment beyond public health emergencies. But the group suggested that if FDA intends to publish Level 1 guidance documents for immediate implementation, it do so as interim final documents with a set period, possibly of 2 years, to be reevaluated and published as final.

“This approach would allow immediate dissemination of information and the consideration of public comments prior to issuance of the permanent document,” IPEC–Americas commented.

Guidance documents that could have “critical impact on patient safety or carry substantial life-threatening implications for public health” should be given priority for Level 1 guidance with immediate implementation, according to Moderna. But the company commented that this should be reserved for true emergencies, such as public health crises or pandemics. Additionally, Moderna called on FDA to define the types of situations that would warrant issuing Level 1 guidance without a public comment process.

BioNTech also supported the immediate implementation of Level 1 guidance when it was necessary to protect public health but suggested that FDA provide justification of the decision and post-hoc review.

“The FDA should clearly explain why public comment is not necessary and how the guidance aligns with existing regulations and public health priorities,” BioNTech commented. “While comments may not be considered before implementation, the FDA should encourage stakeholders to submit feedback after the guidance is issued. This feedback can be used to inform future revisions or the development of related guidance documents.”

BioNTech also cautioned against issuing Level 1 guidance documents for advanced therapies such as cell and gene therapy, personalized therapies and immune therapies.

Other ways to streamline guidance

PhRMA offered several suggestions for how the agency could streamline the guideline development process without eliminating the public input during the draft stage, including implementing best practices across agency centers and offices, enhancing FDA’s guidance database, and increasing transparency in the guidance development process.

For example, PhRMA called on FDA not to let guidance languish in “draft” status for years without issuing a final guidance. PhRMA said all FDA centers should aim to follow the example set by the Center for Devices and Radiological Health (CDRH), which seeks to act on draft guidance – by finalizing, withdrawing, reopening the comment period, or reissuing the draft guidance -- within 3 years of the close of the comment period for 80% of guidances and within 5 years for 100% of guidances.

The Association for Accessible Medicines (AAM) also noted that many guidances remain in draft status for expanded periods of time. “This creates uncertainty about whether the draft guidance continues to reflect the agency’s current policy, even apart from the fact that draft guidance is not supposed to be implemented before it is final,” AAM wrote.

Similarly, many older guidance documents have not been revised, even though there have been changes in policy, AAM commented. The group echoed PhRMA’s call for all FDA centers to take the approach of CDRH in conducting periodic review of draft and final guidances that are more than 5 years old. Additionally, AAM recommended that if a review indicates a guidance should be updated, the agency should commit to doing so in a timely fashion. If an update is not necessary, the agency should indicate that a review has been conducted and the guidance reflects current agency thinking.

In terms of transparency, PhRMA suggested that FDA make clear what changes have been made when finalizing a guidance or revising a draft. Additionally, FDA should include a summary of the comments received on draft guidance and how it was addressed. PhRMA also called on the agency to consider developing a publicly available guidance tracker with the status of draft guidance and potential action dates.

The Consumer Healthcare Products Association (CHPA) called on FDA to provide comment opportunities earlier in the guidance development process, even before a draft is issued. CHPA suggested that FDA establish a process for advanced notice of guidance development (ANGD), similar to the concept of advanced notice of proposed rulemaking, that would incorporate industry perspectives early on for rapidly changing topics, such as artificial intelligence.

“The purpose of an [advanced notice of proposed rulemaking] ANPR is to allow the public a specified period to comment on regulations that FDA may pursue as part of future rulemaking. CHPA members suggest this concept of an ANGD because it would give FDA early insights from thought-leaders and interested stakeholders as the Agency develops its positions for the initial draft for select guidances,” CHPA commented. “We do not anticipate the proposed ANGD process would apply to all future FDA guidances but would be invoked as needed based on the subject matter or revisions.”

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Industry advises FDA not to issue more guidances without public comment

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