President-elect Donald Trump's nomination of Dr. Marty Makary as the next FDA Commissioner appears to be calming concerns within the biotech and pharmaceutical sectors regarding potential disruptions over the next four years. The nomination follows anxieties spurred by the selection of Robert F. Kennedy Jr. to lead the Department of Health and Human Services (HHS).
Makary's Nomination: A Sigh of Relief for BioPharma
Dr. Marty Makary, a pancreatic surgeon at Johns Hopkins University, has been nominated to lead the Food and Drug Administration (FDA). If confirmed by the Senate, Makary would oversee the regulation of food, vaccines, drugs, medical devices, and tobacco products. His nomination is perceived as a more reassuring choice compared to Kennedy, who has openly criticized federal health agencies and is known for his vaccine skepticism.
BMO Capital Markets analyst Evan Seigerman noted that Makary "appears well-versed across the continuum of U.S. healthcare and is supportive of evidence-based medical intervention." This sentiment suggests that Makary's leadership may provide a more stable and predictable regulatory environment for the biopharmaceutical industry.
Makary's Views on Healthcare
Makary has been a vocal critic of the U.S. medical establishment, focusing on issues such as high healthcare costs, lack of transparency, and medical errors. While he does not share Kennedy's anti-vaccine views, he has expressed support for Kennedy's "Make America Healthy Again Platform." Notably, Makary has criticized the government's role in disseminating misinformation, particularly citing the food pyramid as an example.
During the COVID-19 pandemic, Makary supported universal masking and early vaccine doses but opposed vaccine mandates and questioned the necessity of booster shots for children. He also criticized the FDA for its slow authorization of certain COVID-19 related products.
Potential Impacts on Product Approvals and Monitoring
Seigerman anticipates that Makary's support for informed patient choice could lead to a lower threshold for product approvals. However, this may be balanced by stricter requirements for disclosing the risks and benefits of drugs to patients, along with enhanced post-approval monitoring of treatments.
"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 stated.
Neuralink's Brain-Computer Interface Advances
In related news, Elon Musk's neurotech company, Neuralink, has received approval for a new trial to assess the use of its brain implant in controlling an assistive robotic arm. This trial, known as the "CONVOY Study," builds upon Neuralink's "PRIME Study," which has already seen two human patients implanted with the brain-computer interface (BCI).
Neuralink's BCI technology aims to enable paralyzed individuals to control external devices, such as computers and smartphones, using their thoughts. The implant records neural signals via 64 "threads" inserted directly into the brain.
Patients with quadriplegia resulting from spinal cord injuries or degenerative diseases like amyotrophic lateral sclerosis (ALS) may be eligible for the trial. Neuralink has also been approved to launch its first international trial in Canada, further expanding its research efforts.
BCI Industry Landscape
Neuralink is among several companies, including Synchron, Paradromics, and Precision Neuroscience, developing BCI systems. While human trials are underway, no BCI company has yet received FDA approval to commercialize its devices.
