Trump's FDA pick of Makary may be a relief for biotech and pharma

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Happy Tuesday! The selection of President-elect Donald Trump to lead the Food and Drug Administration appears to be allaying fears about a major disruption to the biotech and pharmaceutical industry over the next four years.

Trump on Friday nominated Dr. Marty Makary, a pancreas surgeon at Johns Hopkins University, to be FDA commissioner. If confirmed by the Senate, Makary would be in charge of regulating food, thousands of vaccines and other medications, medical devices and tobacco products.

It would respond to Trump's most controversial pick 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.

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

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

Makary likely has a “more reasonable approach to running the FDA than feared,” BMO Capital Markets analyst Evan Seigerman wrote in a note on Sunday, adding that Makary “appears to be well-versed across the spectrum.” of American healthcare and supports evidence-based medical intervention.

“Overall, we believe the FDA's election should allow BioPharma investors some breathing room, eliminating uncertainty and may reverse significant reductions the week RFK Jr. was named head of HHS,” Seigerman said.

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

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

He added that Makary's “familiarity with the [healthcare] industry that we believe will be noticed often.

So what are Makary's views on health in America?

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

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

Makary has been a controversial figure in other ways, particularly during the Covid-19 pandemic. He aligned himself with traditional public health experts in some respects, supporting universal mask-wearing and early vaccine doses.

But Makary also opposed vaccination mandates and questioned the value of booster shots for children. He also questioned the closures, among other tools pushed by public health officials. Additionally, he 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 may lead to a lower bar for product approval. This will likely be offset by a higher requirement to disclose the risks and benefits of a drug to patients, along with more requirements to monitor 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 a positive,” Seigerman said.

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

We'll be watching to see if the Senate confirms Trump's health picks, so stay tuned for our coverage.

Please feel free to send any tips, suggestions, story ideas or information to Annika at [email protected].

Elon Musk's neurotechnology startup Neuralink announced Monday that it received approval for a new trial that will test 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” that are inserted directly into the brain, according to Neuralink's website.

Two human patients have so far been implanted with the BCI as part of Neuralink's “PRIME Study”, which aims to demonstrate 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 cross-enroll in both studies.

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

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

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

Neuralink also announced last week that it received approval to launch its first international trial in Canada. Like the PRIME study, the goal of the trial in Canada is to demonstrate the safety and effectiveness of Neuralink's technology, according to a blog post.

Patients with quadriplegia from a spinal cord injury or a degenerative disease such as amyotrophic lateral sclerosis (ALS) may be eligible to participate, and recruitment is now open, Neuralink said in a post 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 companies have received approval from the US Food and Drug Administration to market their devices.

Please feel free to send any tips, suggestions, story ideas, or information to Ashley at [email protected].