US FDA’s Drug Approval Norms Could Be Upended In Second Trump Term

Norms, not laws, the key barrier separating the US Food and Drug Administration’s current drug approval process from interference by political officials, easily could be shattered during a second Trump administration.

A lot of the authority typically thought of as in the hands of career FDA scientists, statisticians and medical professionals actually is delegated down from duties Congress gave to the Secretary of Health and Human Services, a political role and presidential appointee.

The HHS secretary has the ultimate legal authority to approve or reject an application.

Kathleen Sebelius, President Barack Obama’s HHS secretary, cited 21 USC Section 393(d)(2), which states that “the Secretary, through the Commissioner, shall be responsible for executing” Food, Drug and Cosmetic Act provisions, in her 2011 memo overruling FDA commissioner Margaret Hamburg and denying Teva Pharmaceutical Industries Ltd.‘s request that emergency contraception known as Plan B be made available for nonprescription use.

The Plan B decision is generally cited as an exception to the rule, and prior to Trump’s first presidency it largely stood alone. Then during the COVID-19 pandemic in 2020, political pressure was seen as influencing the FDA’s authorizations for hydroxychloroquine and chloroquine and convalescent plasma to treat people with the virus.

Prior to COIVD-19, the Trump FDA was seen as operating under the typical norms, where less than a handful of political staff work in the commissioner’s office and have a say in policy development, but keep their hands off individual approval decisions.

Trump’s first FDA commissioner Scott Gottlieb, enjoyed an unusual level of freedom from the White House and was largely seen as keeping the agency on its regular tracks, operating as a traditional Republican FDA commissioner.

Gottlieb has warned that FDA independence from the White House is unlikely in a second Trump term.

Trump’s embrace of anti-vaccine skeptic Robert F. Kennedy Jr. in the last few weeks of the campaign as Kennedy spoke out against the FDA and the pharma industry have stoked fears about the type of commissioner Trump will appoint.

Most close agency watchers do not anticipate Kennedy will get the FDA job or the HHS top slot, but also do not anticipate a “Gottlieb-type” taking those posts. They expect the roles will go to people more closely tied to Trump’s MAGA world, his unique brand of populism and Republicanism.

Lack Of Fear

For political appointees who want to interfere with FDA approvals there is not much to restrain them.

Concern that interference could become public and create a scandal is one of the main fears stopping politicians from interfering with FDA.

“The norm is somebody’s going to be a whistleblower and that’s going to create a storm,” a former senior FDA official told Pink Sheet. “But if you have a Congress and all and the rest of the environment that doesn’t care about the storm, then it doesn’t matter anymore.”

With Republicans poised to potentially take back full control of Congress and many lawmakers who owe their election to Trump and who closely identify with the MAGA element of the party, there is skepticism the legislature will save the FDA from White House interference.

Fear of litigation, which may prevent some from violating norms, is likely not a major factor when it comes to approving a drug because it is challenging for someone to show the harm required to obtain legal standing.

This summer the Supreme Court ruled plaintiffs in a high-profile case challenging the FDA’s regulation of the abortion pill mifepristone lacked standing, saying those who do not prescribe or use the drug, or are not required by the FDA to do or refrain from doing anything should not have been able to bring the case to court.

Other agency action also can be hard to challenge in court.

“A lot of FDA enforcement stuff you can’t really sue about,” the former FDA official added. “It’s very hard, because a lot of it’s not final agency action. So, you don’t have that as a safeguard very much.”

More Difficulty Pulling Product From Market

Pulling a product off the market is likely more challenging for politically motivated actors opposing agency scientists.

“That’s very hard to do,” the official said. “You’d have to be very determined.”

The formal process takes substantial time and energy and the political officials likely would need some support from career staff to help make their case. The drug sponsor also likely would sue and get to choose the legal venue, the ex-FDA official explained.

“So they’re not going to go to Amarillo, TX,” the ex-official said. “They’ll go to like the District of Columbia.”

The government also would have to ensure the decision was not arbitrary.

“And if you have a vaccine that‘s been on the market for 20 years and there’s all the safety data, it’s just hard to do,” the ex-FDA official said.

The Supreme Court’s recent gutting of Chevron deference would work against Trump because there would be less deference to agency decision making.

“I‘m not so sure even this Supreme Court, and maybe mifepristone is an example of this, would be terribly keen on [messing] up the approval process like that,” the former senior FDA official said.

Vaccines in development would be at increased risk. The FDA would have an easier time altering standards for a new applicant or taking a different stance on the risk-benefit calculus posed by the data at hand.

Some factors may temper the Trump administration’s behavior.

“I don’t think they want to have four years of guerrilla war with the medical industry … and some of the people in Trump’s orbit have a foot in the establishment," via investments and other interests in the pharmaceutical industry, the official said.

Others think the fear of interference and drastic changes coming to the FDA is overblown and that other stakeholders including Congress, industry and patient groups would help moderate the Trump Administration.

“We hear something about the FDA every election, but the FDA lives on because of those push-pull forces,” another former senior FDA official who was at the agency during the first Trump administration said.

Brain Drain

One factor that could impact the amount of political interference is the makeup of the FDA’s staff.

Concerns have increased that political interference could occur in conjunction with a large departure of career FDA staff, as well as moves by the Trump Administration to expand the number of politically aligned workers at the agency.

Staff may choose to voluntarily leave rather than contend with the Trump Administration, particularly those nearing retirement.

The Trump-aligned Project 2025, organized by the Heritage Foundation, has proposed a range of policies, including budget cuts and hiring freezes, which could drastically constrict the federal workforce.

Meanwhile Trump and Project 2025 have contemplated classifying more federal employees as Schedule F, which would make many federal officials working on policy at-will employees who could be more easily fired if they don’t follow the administration’s whims. Trump tried to implement the policy at the end of his first term, but never enacted it after losing to President Biden.

Other FDA staff in the senior executive service are vulnerable without the Schedule F change.

The center directors “can be removed or reassigned at the stroke of a pen,” the former FDA official said. “They’re not protected from that by the civil service laws.”

Center for Biologics Evaluation and Research Director Peter Marks may be among those in line for removal given the first Trump administration’s frustration that the FDA did not authorize COVID-19 vaccines until after the 2020 election.

As the Pfizer/BioNTech vaccines were on the cusp of approval, Trump’s then Chief of Staff Mark Meadows reportedly called then FDA Commissioner Stephen Hahn and told him to resign if the product was not approved that day. The Emergency Use Authorization was granted later that evening.