Biotech and Pharma May Benefit from Trump's FDA Pick Makary, Analysts Predict

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It seems that President-elect Donald Trump's selection for head of the Food and Drug Administration is easing concerns about significant upheaval in the biotech and pharmaceutical sector during the next four years.

On Friday, Trump appointed Dr. Marty Makary, a pancreatic surgeon at Johns Hopkins University, as the FDA commissioner. If confirmed by the Senate, Makary would oversee the regulation of food, vaccines, drugs, medical devices, and tobacco products.

Robert F. Kennedy Jr., a prominent vaccine skeptic and former environmental lawyer, would be Trump's more controversial pick to lead the Department of Health and Human Services. He needs Senate confirmation.

Both Kennedy and Makary have recently criticized the government for not prioritizing chronic diseases.

Makary, unlike Kennedy, has a more traditional health background as an experienced medical doctor and is also an executive of the telehealth company Sesame, which connects consumers to physicians who can prescribe compounded versions of popular weight loss drugs.

Evan Seigerman, a BMO Capital Markets analyst, believes that Makary is likely to adopt a more "reasonable approach to running the FDA than has been feared." He also notes that Makary appears knowledgeable about the entire spectrum of US healthcare and supports evidence-based medical interventions.

Seigerman believes that the FDA should choose BioPharma investors for the pick, which would remove uncertainty and potentially reverse significant drawdowns that occurred after RFK Jr. was nominated head of HHS.

Concerns among health experts and investors intensified that Trump might appoint someone to head the FDA without a medical background, potentially politicizing drug regulation and jeopardizing new product approvals and broader innovation in the industry.

Jared Holz, Mizuho health care equity strategist, stated in an email last week that Makary is expected to promote technology/innovation in a way that offers some relief for those fearing a department more aligned with different virtues.

Makary's familiarity with the healthcare industry is expected to be recognized frequently.

So, what are Makary's views on health in the U.S.?

Makary has long been critical of the U.S. medical establishment, focusing on issues such as the high costs of healthcare, the lack of transparency in medicine, and medical errors through research and publication of books.

Makary does not share the same anti-vaccine stance as Kennedy, but has recently expressed support for Kennedy's "Make America Healthy Again Platform." Makary previously stated that the biggest source of misinformation has been the US government, specifically regarding the food pyramid.

Makary has been a contentious figure, particularly during the Covid-19 pandemic. He supported universal masking and early doses of the vaccines in some ways, but aligned with traditional public health experts in others.

Makary opposed vaccine mandates and questioned the value of booster shots for children, and also questioned lockdowns. He emerged as a critic of the FDA during the pandemic, slamming the agency for moving too slowly to authorize certain products for Covid.

Markary's support of informed patient choice may lead to a lower bar for product approvals, but this will likely be offset by a higher bar for disclosing the risks and benefits of a drug to patients, as well as more requirements for monitoring treatments after their approval.

Dr. Makary's critical, flexible, and reasonable opinions and support of patient choice are viewed positively, according to Seigerman.

Weldon, a medical doctor and Republican congressman from Florida, has a history of criticizing vaccinations, which makes Seigerman cautious about Trump's pick to lead the Centers for Disease Control and Prevention.

We'll closely monitor the confirmation of Trump's health picks by the Senate, so stay tuned for our coverage.

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Latest in health-care tech: Neuralink approved for new studies, company says

On Monday, Neuralink, Elon Musk's neurotech startup, announced it has received approval for a new trial to evaluate whether patients can control an assistive robotic arm using a brain implant.

Neuralink is developing a brain-computer interface (BCI) that enables paralyzed individuals to control external devices such as computers and smartphones using their thoughts. The company's primary implant captures neural signals through 64 "threads" that are directly inserted into the brain, as stated on Neuralink's website.

Two human patients have been implanted with BCI as part of Neuralink's "PRIME Study," which aims to prove the system's safety and usefulness. Neuralink's new trial, "CONVOY Study," will investigate whether patients can use the same BCI to control a robotic arm. Patients can enroll in both studies.

Neuralink stated in a post that this initial action is crucial in restoring not only digital liberty, but also physical freedom.

According to the X post, Neuralink plans to provide more details about the study, including the start date and number of participants.

The company did not respond to CNBC's request for comment.

Neuralink has received approval to conduct its first international trial in Canada, with the aim of demonstrating the safety and effectiveness of its technology, as stated in a blog post.

Individuals with quadriplegia resulting from a spinal cord injury or ALS may be eligible to participate in Neuralink's program, and recruitment is currently underway, the company announced on X.

BCI systems are being developed by various companies, including Neuralink, Synchron, Paradromics, and Precision Neuroscience, in addition to being studied in academia for many years.

No BCI company has been approved by the U.S. Food and Drug Administration to market their devices, although several groups are conducting human trials.

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