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ALLISON GATLIN

Senators Grill FDA Nominee Marty Makary Over Abortion Pills, Vaccines

A Senate committee grilled Dr. Marty Makary on Thursday over his views on access to abortion pills and vaccines ahead of his potential confirmation as the new head of the Food and Drug Administration.

Much of the less than three-hour hearing focused on access to mifepristone and misoprostol. Access to the two were broadened under the Biden administration, which allowed people to obtain the pills without an in-person medical appointment. Since then, Republican lawmakers have pushed for their restriction, while Democrats have called for maintaining current availability.

The hearing before the Senate Committee on Health, Education, Labor and Pensions also focused on vaccines with fresh concerns that Health Secretary Robert F. Kennedy would influence policies around safety studies and access. Kennedy is a well-known vaccine skeptic. Makary, a pancreatic surgeon and health researcher with Johns Hopkins, has criticized the overuse of Covid vaccines in people at low risk of serious disease.

After the hearing, RBC Capital Markets analysts said Makary will be a "measured commissioner" of the FDA, if confirmed.

"Overall, we believe the hearing was fairly uncontroversial, relative to some other nomination hearings we have watched, indicating to us that Dr. Makary will presumably have the votes to become the new FDA Commissioner," they wrote in a client note.

Biotech stocks have struggled over the last month, falling 11% from a 2025 high on Feb. 6, according to MarketSurge. The dive follows the confirmation of RFK Jr., but also a broader market pullback after President Donald Trump announced tariffs on imports from Mexico, Canada and China.

Marty Makary Grilled On Abortion

Throughout the hearing, several senators noted abortion laws and the FDA's oversight. The topic has become a political flashpoint after the Supreme Court overturned the national right to abortion in 2022. Since then, groups have pushed for the FDA to withdraw approval for mifepristone.

In a heated exchange, Sen. Maggie Hassan, D-N.H., asked whether Makary would "unilaterally overrule the data that currently exists for political purposes."

"We need to know that when you say you're an independent scientist that that's really what you mean and when the politics get heated around abortion that you won't abandon that independence," she said.

Makary said, if confirmed, he would review the data.

"I have no preconceived plans to make changes to the mifepristone policy and I do plan to follow the law and the regulation of the REMS to follow the data," he said. "If you look at my track record, I have never been afraid to speak my honest, scientific opinion and I have no preconceived plans to make changes on that medication."

Vaccines Under Makary, RFK Jr.

When it came to vaccines, several senators noted the FDA recently canceled the annual meeting to identify which strains to include in this year's flu shots. As the head of the FDA, Makary would oversee the development and approval of all vaccines, including the flu shots.

Makary reminded the senators that he wasn't responsible for canceling the meeting. Kennedy, though, has a long track record of criticizing vaccines and, following his confirmation, doubled down on his view that vaccines don't undergo enough safety testing. Experts say that's a baseless claim.

Early in the pandemic, Makary wrote in support of widespread vaccinations, including for older people and those at risk. But in 2022, he criticized the medical establishment for ignoring the benefits of natural immunity — i.e., contracting the virus and then naturally developing antibodies.

"Vaccines were wasted on those who didn't need them, and people who posed no risk lost jobs," he said in a January 2022 opinion piece for the Wall Street Journal.

He reiterated that view during the hearing Thursday, suggesting there's no need to require "every 12-year-old girl to get an eighth Covid booster." He also criticized the FDA for granting a "rubber stamp" to every vaccine under the World Health Organization's Global Influenza Program.

This suggests "he may be less inclined to hold panels for the sake of having them, and could indicate less willingness for other (advisory committees) as well," RBC analysts said.

Faster Biosimilar, Generic Approvals

Promisingly, for some biotech stocks, Makary seems to favor a faster approval process for biosimilar and less expensive generic medicines. He noted patent thickening "makes it more difficult for biosimilars and some generics to come to market."

RBC's analysts noted this could be a headwind for companies like Regeneron Pharmaceuticals and Gilead Sciences, which relay on patent strategies to extend sales of some products.

"Though we believe FDA plays a limited role in enforcing such direction and, on the contrary, this may also incentivize more (mergers and acquisitions) activity in the space," they said.

Makary also seems to favor accelerated approvals for drugs that treat rare diseases. This would benefit companies like Sarepta Therapeutics, PTC Therapeutics, Biohaven, Agios Pharmaceuticals and others.

Will Marty Makary Align With RFK Jr.?

Makary appeared "particularly passionate" about Kennedy's Make America Healthy Again movement, RBC analysts said.

As part of his writings, Makary has criticized the medical system for overmedicating patients and not focusing enough on the underlying cause of chronic diseases. Further, he has expressed concern about weight-loss drugs, noting the potential for patients to lose lean muscle mass.

He has also written about the overuse of antibiotics in children and the "poisoned" food supply. He pointed to both as a cause of chronic disease.

"Diseases are rapidly causing widespread suffering," he said in an October 2024 post on X, linking to a podcast from comedian Joe Rogan. "More meds are not the answer."

RBC analysts, though, say this is too simplistic of a view.

"We believe this is somewhat of a misleading distortion, as this is likely at least in part from improved screening for diseases such as cancer, mental health disorders and genetic illnesses — innovative treatments for which have helped meaningfully increase the overall U.S. (life) expectancy over the past 50 years," they wrote.

Eyeing The Food Supply

Like Kennedy, analysts expect Makary to focus on the food supply. In an October post on Instagram, he pointed to ingredient differences between products like Fruit Loops and McDonald's fries in the U.S. and other countries.

"They have the food scientists that have figured out how to put more chemicals to make them more addictive in the United States," he said. "Don't American kids deserve the healthier version of food that American companies make?"

But RBC analysts expect Makary to take a measured stance, rather than overhauling the entire system.

"We continue to believe that he may focus on bigger-picture public health initiatives/food quality, and be less apt to dismantle the organization, and leave drug reviews core to biopharma to existing division leaders," they said. "Though we thought he may not be more industry friendly vs. recent administrations, he did mention explicitly that he still 'wants life sciences companies to thrive.'"

Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.

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