Experts recommend being tactful, concise, and evidentiary when submitting guidance comments

LINTHICUM HEIGHTS, MD – When commenting on US Food and Drug Administration (FDA) draft guidances, experts say commenters should use a collaborative tone, consider that agency staff are very busy, and provide evidence to support their claims. They also said that the comments are often only the start of the conversation, and much of the work developing a guidance happens in follow-up conversations with the agency.

On 13 March, a panel of experts at the 2025 RAPS Regulatory Intelligence conference discussed the do’s and don’ts of submitting effective comments to FDA. Alexander Gaffney, vice president for regulatory policy and intelligence at AgencyIQ, moderated the panel.

Andrew Emmett, executive director for US regulatory policy and global intelligence at Pfizer, said it is important to provide concise comments and advised the audience to remember that FDA staff are often pressed for time and must read through numerous comments. He also noted that it's important to back up their comment claims with data.

"Don't just make claims," said Emmett. "Back them up with data and evidence, that's the language that FDA relies on."

Emmett also told commenters to avoid asking open-ended questions and broad clarifications. Instead, he said they should make specific recommendations and track changes in the draft guidance that they would recommend.

Steve Berman, VP of science and regulatory affairs at the Biotechnology Innovation Organization (BIO), echoed the sentiment and said commenters need to remember who their audience is. He noted that FDA staff are subject matter experts who have spent a lot of time and effort to carefully draft the guidances in question.

“We want to be respectful of their time and of their expertise,” said Berman. “We want to hit that sweet spot of covering all the bases that we need to without being excessive in either length or detail.”

He also said that commenters should consider advocacy groups and legislators when writing their comments since they are public.

"Our legislative affairs offices will often rely on our written guidance comments to help shape their strategies in dealing with legislators," said Berman. "To the extent that we can, we do try to keep that in mind both in terms of technical content and also the length."

Berman said BIO, like other organizations, has an internal style guide for writing comments, but ultimately, the guidance documents are technical documents that make specific suggestions, which requires a relatively high reading level.

“We want to be precise in the message that we're sending, but at the same time, we don't want to be verbose,” he added. “We don't want the language to obscure our message.”

Elizabeth Lange, senior director and head of US global regulatory and scientific policy at EMD Serono, said her company views their relationship with FDA as a partnership. She said they approach writing comments in a “friendly, legal way” and ensure they always have legal representatives at the table at all their workshops when developing comments.

Lange said their objective is to have a dialogue with FDA in which they are humble and make science-based suggestions without making demands. She added that it's crucial to ensure that they back up their recommendations with rationale.

Lange also noted that the European Medicines Agency (EMA) uses a template for stakeholders to submit their comments, but FDA doesn't have any such requirement. Like other organizations, EMD Serono has its own template that it uses to explain that it is a subsidiary of Merck KGaA and other details before delving into its recommendations.

Emmett emphasized that stakeholders should keep their comments professional and collaborative. He said that sometimes commenters can be negative and nit-picky even when they are being supportive, but it's important to strike the right tone.

"A really well-articulated crafted either individual comment or coalition comment can be much more effective than say flooding the docket with thousands of form letters," he added.

Kristy Lupejkis, VP and chief of staff for science and regulatory advocacy at the industry lobby group PhRMA, noted that it operates differently than other entities as a membership organization since it needs to develop consensus among its members before it submits a comment. She said it tries to provide enough information and specificity to allow FDA to understand the basis of its recommendations but also have more direct conversations with the agency afterward to provide more clarity.

“If we're doing our job correctly, we're providing enough consensus-based information there that the group of folks looking at this have what they need for specificity but then also feel like they have an open channel of communication for additional questions,” said Lupejkis.

Lupejkis said there are times when PhRMA can be in “severe opposition” to a guidance that FDA has proposed, and the comment letter is only one part of its strategy to advocate for its members. She noted that they need to be able to have a relationship that allows them to further the dialogue after submitting the comments, so they use language that is broadly supportive of the agency's effort to show deference.

"This part of the broader public docket. We want to make sure we are not in any way denigrating the agency as a whole or folks that are there," said Lupejkis. "If you set up that kind of relationship, then you can have those difficult conversations, but the toughest part of those will come outside the comments place."

Berman said BIO also considers the regulatory environment beyond the guidance in question when submitting comments. For example, he noted that BIO commented on an accelerated approval guidance that closed its comment period last week, where the group considered including a statement about a specific therapeutic area. After considering the political reality and how the trade press may focus on the issue, it decided not to include the statement in its comments. (RELATED: FDA’s accelerated approval guidance gets pushback from industry, Regulatory Focus 7 March 2025)

“Even very valid comments sometimes don't make it into our letter because we do want to be mindful of the environment in which we are playing, and that's where the broader regulatory intelligence picture is so important,” said Berman. “It's not sufficient to just read the guidance. You also need to think about what else is going on, what has the trade press already said.”

Emmett said Pfizer prioritizes which guidances to comment on to get the best bang for the buck. He said sometimes it makes more sense to comment as part of an industry group to show a unified voice, but at other times, when they file separately, it’s to express a unique perspective in an area that may affect them.

“Trade associations work by consensus so not every comment that you put in is going to be reflected in the final output of what the trade association puts out,” said Emmett. “Sometimes, if you do have a particular point of view that doesn’t make it into that final cut, you might want to submit those comments separately.”

He also noted that trade associations often don’t comment on highly technical guidances that address particular therapeutic areas. In such instances, he said comments from individual companies can be useful.

Gaffney also asked how President Donald Trump’s recent executive order to federal agencies requiring them to remove 10 regulations, rules, or guidances for each new one issued, affects their strategy when submitting comments.

Berman said the biotech industry has a unique relationship with FDA, which means they have shared objectives. While other industries may welcome fewer guidances, he said the biotech industry is instead interested in implementing good guidances.

“We have not seen a dramatic decrease in guidances, nor have we seen a dramatic recission of already published guidances,” said Berman. “If and when that happens, we will respond accordingly.”

Experts recommend being tactful, concise, and evidentiary when submitting guidance comments

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