Trump’s FDA choice of Makary could be a relief for biotech and pharmaceutical sectors

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health care news straight to your inbox. Subscribe here to receive future editions.

Happy Tuesday! President-elect Donald Trump’s choice to lead the Food and Drug Administration appears to allay fears of major disruption to the biotechnology and pharmaceutical industry over the next four years.

Trump on Friday nominated Dr. Marty Makary, a pancreatic surgeon at Johns Hopkins University, as FDA commissioner. If confirmed by the Senate, Makary would be responsible for regulating food, thousands of vaccines and other drugs, medical devices and tobacco products.

He would respond to Trump’s more controversial choice to lead the Department of Health and Human Services, Robert F. Kennedy Jr., a prominent vaccine skeptic and former environmental lawyer, who also needs Senate confirmation.

Kennedy and Makary have been outspoken critics of federal health agencies, and both have recently criticized the government for not prioritizing chronic diseases.

But unlike Kennedy, Makary has a more traditional healthcare background as an experienced physician. Makary is also an executive at the telehealth company Sesame, which connects consumers with doctors who can prescribe compounded versions of popular weight-loss drugs.

Makary is likely to have a “more reasonable approach to managing the FDA than feared,” Evan Seigerman, an analyst at BMO Capital Markets, wrote in a note Sunday, adding that Makary “appears to be well versed in the continuum healthcare in the United States and supports the FDA. evidence-based medical intervention.

“Overall, we believe the FDA choice should provide reprieve for BioPharma investors, eliminate uncertainty and could reverse significant declines the week RFK Jr. was named to lead HHS,” a Seigerman said.

Some health experts and investors feared that Trump would choose someone to lead the FDA who lacked appropriate medical training and who could politicize the drug regulatory process within the agency, thereby threatening approval. new products and innovation in general.

“Makary will, we hope, promote technology/innovation in a way that provides some respite for those who [are] fearing a department more aligned with different virtues,” Jared Holz, health care equity strategist at Mizuho, ​​said in an email last week.

He added that Makary’s “familiarity with the [healthcare] We believe this industry will be noticed often. »

So what is Makary’s view on healthcare in the United States?

Makary has long challenged the American medical establishment, researching and publishing books on high health care costs, medicine’s lack of transparency, and medical errors.

Makary does not appear to hold the same anti-vaccine views as Kennedy, but has recently made statements indicating support for Kennedy’s “Make America Healthy Again platform.” Makary said earlier this year that “the biggest perpetrator of misinformation was the US government with its food pyramid.”

Makary has been a controversial figure in other ways, notably during the Covid-19 pandemic. He has aligned himself in some ways with traditional public health experts, supporting universal masking and early doses of vaccines.

But Makary also opposed vaccination mandates and questioned the value of booster shots for children. He also questioned containment measures, among other tools advocated by public health officials. Additionally, he has emerged as a critic of the FDA during the pandemic, criticizing the agency for moving too slowly to authorize certain products for Covid.

Seigerman said Markary’s support for informed patient choice could lead to a lower bar for product approval. This will likely be offset by higher requirements for disclosing a drug’s risks and benefits to patients, as well as increased requirements for monitoring treatments after they are approved.

“In our opinion, Dr. Makary’s willingness to be critical of the system, flexible and reasonable in his opinions and support of patient choice is positive,” Seigerman said.

But Seigerman noted that he was much more cautious about Trump’s choice to lead the Centers for Disease Control and Prevention: Rep. Dave Weldon, a physician and Republican congressman from Florida. This is due to Weldon’s long history of criticizing vaccinations.

We’ll be watching closely to see if Trump’s health care picks are confirmed by the Senate, so stay tuned to our coverage.

Feel free to send tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Elon Musk’s neurotech startup Neuralink announced Monday that it has been approved for a new trial that will evaluate whether patients can use a brain implant to control an assistive robotic arm.

Neuralink is building a brain-computer interface, or BCI, that allows paralyzed people to control external devices like computers and smartphones with their thoughts. The company’s flagship implant records neural signals using 64 “wires” inserted directly into the brain, according to Neuralink’s website.

So far, two human patients have been implanted with the BCI as part of Neuralink’s “PRIME study,” which aims to prove that the system is safe and useful. Neuralink’s new trial, called the “CONVOY study,” will explore whether patients can use the same BCI to operate a robotic arm, the company said in a post on X, which is also owned by Musk. Patients will be able to enroll in both studies.

“This is an important first step towards restoring not only digital freedom, but also physical freedom,” Neuralink said in its message.

It is not yet known when the study will begin or how many patients will participate. Neuralink plans to share more information about the study, according to the X post.

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

Neuralink also announced last week that it had been approved to launch its first international trial in Canada. Like the PRIME study, the goal of the trial in Canada is to prove the safety and effectiveness of Neuralink technology, according to a blog post.

Patients with quadriplegia following spinal cord injury or a degenerative disease like amyotrophic lateral sclerosis (ALS) may be eligible to participate, and recruitment is already open, Neuralink said in an article on X.

BCIs have been studied in academia for decades, and competition within the industry has intensified in recent years. In addition to Neuralink, companies such as Synchron, Paradromics and Precision Neuroscience are developing their own BCI systems.

Several of these groups are conducting human trials, but no BCI company has received approval from the U.S. Food and Drug Administration to market its devices.

Feel free to send tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.