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Happy Tuesday! President-elect Donald Trump’s pick to lead the Food and Drug Administration appears to be quelling fears about a major disruption to the biotech 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 in charge of regulating food, thousands of vaccines and other drugs, medical devices and tobacco products.
He would answer to Trump’s more 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 openly criticized federal health agencies, and both most recently slammed the government for not prioritizing chronic diseases.
But unlike Kennedy, Makary has a more traditional health background as an experienced medical doctor. Makary is also an executive of the telehealth company Sesame, which connects consumers to physicians who can prescribe compounded versions of popular weight loss drugs.
Makary is likely to have a more “reasonable approach to running the FDA than has been feared,” BMO Capital Markets analyst Evan Seigerman wrote in a note on Sunday, adding that Makary “appears well-versed across the continuum of U.S. healthcare and is supportive of evidence-based medical intervention.”
“All in, we think the FDA pick should allow BioPharma investors a reprieve, removing uncertainty and may reverse significant draw downs the week RFK Jr. was nominated head of HHS,” Seigerman said.
Some health experts and investors feared that Trump would pick someone to lead the FDA who lacks a proper medical background and could politicize the drug regulation process at the agency, threatening new product approvals and innovation more broadly.
“Makary we expect will promote technology/innovation in a way that offers some reprieve for those that [are] fearing a department more aligned with different virtues,” Jared Holz, Mizuho health care equity strategist, said in an email last week.
He added that Makary’s “familiarity with the [healthcare] industry we believe will be noted often.”
So, what are Makary’s views on health in the U.S.?
Makary has long challenged the U.S. medical establishment, researching and publishing books about the high costs of health care, the 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 support for Kennedy’s “Make America Healthy Again Platform.” Makary earlier this year said “the greatest perpetrator of misinformation has been the United States government with the food pyramid.”
Makary has been a controversial figure in other ways, particularly during the Covid-19 pandemic. He aligned with traditional public health experts in some ways, supporting universal masking and early doses of the vaccines.
But Makary also opposed vaccine mandates and questioned the value of booster shots for children. He also questioned lockdowns, among other tools that public health officials pushed. In addition, he emerged as a critic of the FDA during the pandemic, slamming the agency for moving too slowly to authorize certain products for Covid.
Seigerman said Markary’s support of informed patient choice may lead to a lower bar for product approvals. That will likely be offset by a higher bar for disclosing the risks and benefits of a drug to patients, along with more requirements for monitoring treatments after their approval.
“In our view, 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 he is much more cautious about Trump’s pick to lead the Centers for Disease Control and Prevention: Rep. Dave Weldon, a medical doctor and Republican congressman from Florida. That’s because of Weldon’s long history of criticizing vaccinations.
We’ll be watching closely to see whether Trump’s health picks get confirmed by the Senate, so stay tuned for our coverage.
Feel free to send any tips, suggestions, story ideas and data to Annika at [email protected].
Latest in health-care tech: Neuralink approved for new studies, company says
Elon Musk’s neurotech startup Neuralink on Monday announced it has been approved for a new trial that will assess whether patients can use a brain implant to control an assistive robotic arm.
Neuralink is building a brain-computer interface, or a 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 “threads” that are inserted directly into the brain, according to Neuralink’s website.
Two human patients have been implanted with the BCI so far 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 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’s 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 the X post.
The company did not respond to CNBC’s request for comment.
Neuralink also announced last week that it has 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 efficacy of Neuralink’s technology, according to a blog post.
Patients with quadriplegia from a spinal cord injury or a degenerative disease like amyotrophic lateral sclerosis (ALS) might be eligible to participate, and recruitment is already open, Neuralink said in a post on X.
BCIs have been studied in academia for decades, and competition within the industry has heated up in recent years. In addition to Neuralink, companies including Synchron, Paradromics and Precision Neuroscience are developing their own BCI systems.
Several of these groups are carrying out human trials, but no BCI company has received approval from the U.S. Food and Drug Administration to commercialize their devices.
Feel free to send any tips, suggestions, story ideas and data to Ashley at [email protected].
