Trump's 10-for-1 order puts pressure on FDA to find regulations to nix

President Donald Trump’s order requiring the removal of 10 regulations, rules, or guidances for each new one issued will put administrative pressure the US Food and Drug Administration (FDA) and other federal health agencies. Experts who spoke to Focus said this could lead to a more frugal stance from regulators when it comes to promulgating new regulations and guidance.

The executive order, issued on 31 January, echoes Trump’s controversial “two-out, one-in” order from the beginning of his first administration in 2017. In issuing the new order, Trump claimed that increasing federal regulations carry significant costs and hamper innovation and competitiveness.

“Despite the magnitude of their impact, these measures are often difficult for the average person or business to understand, as they require synthesizing the collective meaning not just of formal regulations but also rules, memoranda, administrative orders, guidance documents, policy statements, and interagency agreements that are not subject to the Administrative Procedure Act, further increasing compliance costs and the risk of costs of non-compliance,” said Trump. “It is the policy of my Administration to significantly reduce the private expenditures required to comply with Federal regulations to secure America's economic prosperity and national security and the highest possible quality of life for each citizen.”

While the order may seem daunting, Cybil Roehrenbeck, a partner at Hogan Lovells, said it’s “very tenable” but also noted that for the healthcare product industry, it presents opportunities and risks.

"At the beginning of the executive order there's language around the ever-expanding morass of complicated federal rules. I think that's a very apt description," Roehrenbeck told Focus. "We have hundreds of thousands of regulations on the books, and I think actually it’s table stakes to be able to pull back many of those easily."

"Insofar as we have overly burdensome regulations, which encumber innovation, encumber new discoveries, many industry stakeholders are literally making lists of regulations that don't make sense that they'd like to see scaled back, and I expect more work collaboratively with agencies on those,” she added. “At the same time, I'd say any uncertainty creates risks, and in an environment where getting investments can be challenging, uncertainty that goes on too long obviously can be troublesome."

Roehrenbeck noted that the definition of rules and regulations is broad in the order, so it's unclear how in the Trump Administration and the Office of Management and Budget (OMB) might interpret how they are counted. She emphasized that the order also includes memoranda, guidance documents, inter-agency agreements, and policy statements.

Mahnu Davar, a partner at Arnold & Porter, told Focus stressed the scale of the latest deregulatory order by the Trump Administration, and said that it puts a lot more pressure on agencies such as FDA to find rules, regulations and guidances in the books that can be eliminated.

“Ten-for-one is definitely much more than two-for-one,” said Davar. However, he said that the 2017 order didn’t have a large impact on FDA or industry. At this stage, he said it is hard to tell how the new order will compare to the old one, but it has the potential to have a greater impact on what guidances make it to finalization.

“[The old order] was successful in the sense that it forced FDA to do some house cleaning of rules, regulations and guidances that were in the books but that weren’t really used,” he added.

Philip Desjardins, another partner at Arnold & Porter, agreed with this assessment and told Focus that the new order puts even more pressure on FDA to be thoughtful about the cost-benefit analysis of keeping certain regulations and guidances versus trying to adopt new ones.

“One issue that will be important to watch is how FDA adopts rules, regulations, and guidances that are congressionally mandated,” he added.

“This administration has taken a completely different approach in terms of speed, depth of changes, and also the understanding of the requirements and rules that folks have to abide by to make wholesale change in government," Roehrenbeck said. "Obviously, there's a lot that still needs to be done, and that is why President Trump came back, and the administration has a plan on how to make numerous changes."

Roehrenbeck said the new order needs to be seen in the context of Trump's other orders, including those on funding and communications freezes. She also said until the administration is able to appoint new agency heads at the Department of Health and Human Services (HHS), it may be taking a pause to figure out what regulations are already out there that they want to proceed with and what they want to pull back on. (RELATED: Experts: Trump executive orders create foundation for what’s to come, Regulatory Focus 24 January 2025)

Roehrenbeck noted that OMB will play a critical role in overseeing what rules and regulations are released and that office’s personnel and the documents it produces will be even more important to the regulatory environment.

Roehrenbeck emphasized that one issue that could have a significant impact from the new order is the requirement that any new regulation would have to either have a net zero cost or cost less than removing old regulations.

“Obviously, for each regulation we do typically receive an estimate of the cost burden of that regulation,” said Roehrenbeck. “Sometimes it's limited to what will the cost burden be for implementation of the regulation rather than what will the cost burden be for businesses and citizens to comply with the regulation.”

“I think it'll be interesting to see how costs are determined and attributed to those regulations that are being rescinded and those that are being proposed," she added.

For FDA stakeholders, Roehrenbeck said it will be important to watch what the Trump administration puts out when it updates the HHS unified agenda, as this could differ considerably from the recent Fall 2024 agenda published during the Biden administration.

"The unified agenda will be illustrative of what the scope and the plan is in terms of new regulations,” said Roehrenbeck. “It might be quite short."

According to Desjardins, another area to watch is how FDA maintains its de novo process of classifying medical devices, as the agency issues a classification order for these requests and it’s unclear whether such requests will be impacted by the order.

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Trump's 10-for-1 order puts pressure on FDA to find regulations to nix

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