Advamed CEO Scott Whitaker stressed the need for the Food and Drug Administration to maintain safety standards in a statement responding to President-elect Donald Trump’s nomination of Martin Makary to lead the agency.
Whitaker, who was fairly positive about Trump nominating Mehmet Oz as Centers for Medicare and Medicaid Services administrator, said in a statement Friday that Makary’s career as a surgeon and professor should help him understand the value of medical technology for patients.
“It is critical that FDA maintain the highest standards for safety and efficacy while ensuring the review process is efficient, transparent, and predictable to ensure every patient has access to the best medical technologies,” said Whitaker, who leads one of the most influential medical device lobbying groups.
The American Clinical Laboratory Association, a diagnostics industry group challenging the FDA’s laboratory developed test final rule in court, declined to comment on the Makary nomination. MDMA, a representative for device manufacturers, did not immediately respond to a request for comment.
Trump announced his nomination of Makary Friday on the social media platform Truth Social. Makary, a Johns Hopkins surgeon and public policy researcher, is seen as more of a traditional pick compared with Oz and Robert F. Kennedy Jr., who Trump nominated to lead the Department of Health and Human Services.
Makary has criticized the FDA in the past, particularly regarding actions taken during the COVID-19 pandemic including approving vaccine boosters for young people.
Rick Weissenstein, a TD Cowen analyst, wrote in a research note Monday that Makary’s “scathing” views of the FDA will not likely hold up his confirmation. But Weissenstein was critical of Makary’s knowledge of how the FDA runs.
“[Makary] will be coming to FDA with some strongly held views on the agency’s decision-making in the COVID pandemic – but seemingly little in-depth knowledge of how FDA operates or the laws and precedents it follows,” Weissenstein wrote. The analyst added, “Politically, Makary seems like a good fit with the emerging Trump health team.”
Makary could have the largest influence over the medtech industry among Trump’s health nominees, as the FDA’s Center for Devices and Radiological Health oversees medical devices. However, CMS decides whether Medicare will cover devices and treatments.
One key question is whether CDRH leadership will change amid Trump’s picks of non-traditional health leaders. CDRH Director Michelle Tarver took over the center just a few months ago. Former-Director Jeff Shuren served under three presidents over his 15-year career leading the center: President Joe Biden, Trump and former President Barack Obama.
The CDRH is also dealing with a review of its medical device recall process by the Government Accountability Office, questions around how to regulate artificial intelligence amid a surge in the use of the technology and a legal challenge to the FDA’s final rule increasing its regulatory power over LDTs. New FDA leadership could change how the agency approaches implementation of the final rule.
Makary has authored numerous papers in medical journals on topics ranging from medical errors causing patient deaths to the overprescription of opioids. In 2011, Makary was the lead author of a study critical of how hospitals presented information on their websites about robotic surgery.
“No hospital website mentioned risks,” the study’s abstract stated. “Materials provided by hospitals regarding the surgical robot overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer.”
In a 2011 post from Harvard Prostate Knowledge, Makary said that hospitals “need to be more conscientious of their role as trusted medical advisers and ensure that information provided on their Web sites represents the best available evidence.”
Makary will require confirmation by the U.S. Senate.