FDA nominee Marty Makary outlines vision for improving public health

Marty Makary, President Donald J. Trump’s nominee to lead the US Food and Drug Administration, sailed through questioning during a Senate confirmation hearing on March 6, paving the way for the Johns Hopkins Hospital surgeon to oversee the US agency responsible for the safety of drugs, medical products, and food.

He vowed to streamline drug approvals, ensure food safety, and rebuild trust in public health, emphasizing three key themes: science-based evidence, common sense, and transparency.

Makary showed senators his in-depth knowledge of the US health-care system, which he said “has become too fragmented, too cold, and too corporate.” Makary’s research on the topic led him to write books on price gouging and predatory billing in health care, which he says led to advocacy for more transparency in drug prices.

Sen. Bill Cassidy (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, which held the confirmation hearing, stressed the importance of restoring trust in public health and science agencies and the products they regulate.

“Rebuilding public confidence in medical products, like vaccines, is especially important as we respond to measles outbreaks and as FDA considers recommendations for vaccines for flu strains ahead of the upcoming flu season,” he said in his opening remarks.

When asked about rescheduling a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee to examine data on influenza strains to develop a shot for the next flu season, Makary committed to reevaluating which topics need to be discussed by the committee. He did not commit to rescheduling the annual flu vaccine meeting, which was abruptly canceled with no explanation on Feb. 26.

Makary noted that in 7 of the past 7 years, the FDA has “rubber-stamped” recommendations for the next flu vaccine from the World Health Organization’s Global Influenza Programme.

Throughout the hearing, Makary pledged that if he is confirmed to lead the FDA, he will ensure that the agency follows the science, uses common sense, and increases transparency in public health decisions.

He also said he is on board with the Make America Healthy Again movement, which aims to find the root causes for childhood illnesses, including prediabetes in teens. “Childhood obesity is not a willpower problem,” Makary testified. “We should be, and we will be, addressing food as it impacts our health.”

Much of Makary’s research has focused on the question, Is what we are doing working? He testified that his books aim “to educate the public on medical science and to empower them to live healthier lives.” To that end, Makary told lawmakers that he wants to make continuous glucose monitors and continuous blood pressure monitors available without prescriptions so that people can benefit from the technology and help prevent illnesses before they arise.

He also floated the idea of making EpiPens, which are used to inject epinephrine to treat life-threatening allergic reactions, available over the counter.

“We now have a generational opportunity to usher in radical transparency and to facilitate more cures, meaningful treatments, and diagnostics at the FDA to help people take care of their own health,” Makary said.

The HELP Committee has yet to clear Makary’s nomination for a vote in the full Senate. But with a relative lack of controversy surrounding his selection by Trump, his confirmation is considered highly likely. He told lawmakers that if he is confirmed, he will voluntarily divest from all entities that were flagged as conflicts of interest in a routine government ethics review.