FDA’s New Guidance Plan to Face Trump’s Transparency Efforts

A revamped plan to streamline the FDA’s guidance practices stands to be tested as President-elect Donald Trump looks to follow through on plans to bring more transparency and efficiency to the government.

The Food and Drug Administration published in December its plan outlining new approaches to how it will issue and implement an increasing number of guidance documents that describe the agency’s interpretation of regulations and policies.

Trump has said his picks to lead major health agencies will restore “the traditions of Gold Standard Scientific Research, and beacons of Transparency,” in particular through Robert F. Kennedy Jr., as health secretary, and Marty Makary, as FDA chief. Trump has also formed a new advisory team, dubbed the Department of Government Efficiency, led by Elon Musk and Vivek Ramaswamy to slash excess regulations, spending, and restructure agencies.

How the FDA executes its new guidance plan will depend on whether the Trump administration works to undermine or strengthen the effort as it pursues transparency and efficiency.

“We have a very educated guess that this administration will be focused on transparency, and I do think that the guidance plan supports that transparency,” said Felicia Leborgne Nowels, a partner in the government affairs and public policy practice at Akerman LLP.

“A counterpoint to it is, if Trump and the FDA administration take the historic approach of less regulatory oversight, it’ll be interesting to see if the administration releases new guidance.”

‘Headwinds’ for Plan

The FDA was required by the fiscal 2023 federal spending law to issue a new report identifying best practices for guidance documents. The FDA’s final report explains its plans to enhance guidance communication and outreach; update the FDA’s Good Guidance Practice Regulation; and promote the continued use of guidance.

Notably, the agency underscored that it has significantly increased the number of guidance documents it publishes annually and is seeking to implement practices that will enhance its publications.

However, the FDA’s plan could face some hurdles.

“I see a dilemma for the agency,” said Dominick P. DiSabatino, a partner in the life sciences team at Sheppard, Mullin, Richter & Hampton LLP. “They have to produce this document that says how they’re going to do guidance—and then they face headwinds.”

Ramaswamy in a Nov. 15 post on X wrote that the FDA is one of the agencies that has “too much bureaucracy.”

“FDA’s day-to-day decisions include not just the final drug approval decisions that grab headlines, but their micromanagement of every single step of the clinical & even preclinical drug development process,” Ramaswamy wrote Nov. 18 in a separate X post.

The FDA’s plan “stands in a spot where the agency can use it as a tool to advance their policies or use it to take a hands off approach,” Nowels said.

The FDA also faces challenges due to recent scrutiny in federal courts over federal agency interpretations, especially after the US Supreme Court’s decision in Loper Bright Enters. v. Raimondo. The justices in that case tossed the Chevron doctrine that previously bolstered agency interpretations of unclear laws.

While the high court’s decision doesn’t apply to guidances, which aren’t legally binding, the documents have become part of litigation as courts analyze the agency’s thinking.

The most recent example was in FDA v. Wages and White Lion Investments, where the Supreme Court scrutinized the FDA’s interpretation for the studies it requires e-cigarette manufacturers to submit to the agency in order to get their products approved.

“The FDA is being clear that in a post-Loper world, they’re not going to mess around when it comes to defining the extent of their authority to enforce regulation,” DiSabatino said.

“FDA notes that it issues more guidances than rules,” said Alan G. Minsk, a partner and leader of the food and drug practice at Arnall Golden Gregory LLP. “It was doing this pre-Chevron decision, and I think FDA, like many agencies, will continue to do this for fear of lawsuits if they issue final rules.”

Trump’s Interpretations

Industry watchers are eyeing areas that the administration will target to protect the public health, a motive that could impact agency guidance.

The FDA’s draft plan proposed to issue more Level 1 guidance documents for immediate implementation and omit the comment period under certain circumstances. Level 1 guidance is more significant and includes initial interpretations of a statute or regulation.

However, the industry pushed back on that consideration.

The final plan said it intends to provide prior public participation for draft Level 1 guidance documents unless it’s not feasible or appropriate. This includes when there are public health reasons for the immediate implementation; a statutory requirement, executive order, or court order that requires immediate implementation; or the guidance presents a less burdensome policy that is consistent with public health.

“What is up in the air with the new administration coming in is how they will interpret the standards for implementing Level 1 guidance without comment,” said Kyle A. Dolinsky, an associate at Troutman Pepper Hamilton Sanders LLP.

“The guidance process is vital, and there is that balance to be struck between getting industry comments, stakeholder comments, and being able to implement them.”

Former agency officials predict Kennedy’s vaccine skepticism and opposition to pharmaceutical direct-to-consumer promotions signal where he could wade into the agency. Makary’s ties to a telehealth company that offers compounded weight loss drugs could also impact the agency’s thinking on drug compounding.

“It will be interesting to see direction from the higher-ups on ‘transparency’ and ‘get things done,’” Minsk said about Trump’s health picks.

“FDA is trying to find a balance of transparency, which industry and the public want, and practical time and resource constraints. It clearly notes the value of public input, document availability and overall disclosure.”