President-elect Donald Trump has nominated Dr. Marty Makary to lead the Food and Drug Administration (FDA), a decision that has sparked controversy due to Makary’s opposition to vaccine mandates and other public health measures during the coronavirus pandemic. Makary, a professor at Johns Hopkins University, is known for his criticism of the health system, particularly the overprescribing of drugs, the use of pesticides on foods, and the influence of pharmaceutical and insurance companies over doctors and regulators.
In a statement announcing the nomination, Trump praised Makary as someone who would restore the FDA to a “gold standard of scientific research” and cut bureaucratic red tape to ensure Americans receive the medical treatments they deserve. Makary’s confirmation will need to be approved by the Republican-led Senate.
The FDA, headquartered in Maryland, is responsible for overseeing the safety and effectiveness of prescription drugs, vaccines, medical devices, and various consumer goods, representing a significant portion of U.S. consumer spending. Makary’s nomination comes at a time when the health system is under scrutiny for its handling of the COVID-19 pandemic.
Throughout the pandemic, Makary gained attention for his contrarian views on masking, vaccinations, and herd immunity. While he did not oppose the COVID-19 vaccine, Makary expressed concerns about vaccinating young children and advocated for a greater emphasis on herd immunity as a means to stop the virus.
In a Wall Street Journal article in February 2021, Makary predicted that COVID-19 would be mostly gone by April, allowing Americans to resume normal life. However, subsequent variants of the virus, such as delta and omicron, led to additional waves of infections and deaths, challenging Makary’s earlier predictions.
If confirmed, Makary would work under the oversight of anti-vaccine activist Robert F. Kennedy Jr., who is Trump’s pick to oversee the Department of Health and Human Services. While Makary does not share Kennedy’s views on vaccines, he shares a similar distrust of the pharmaceutical industry, particularly in relation to the marketing of opioids and other drugs.
Makary has criticized drugmakers for using misleading data to promote opioids as non-addictive pain relievers and has called for greater scrutiny of drug safety and effectiveness at the FDA. This shift would mark a departure from the agency’s focus on speedy drug approvals, driven by industry lobbying and fees paid by drugmakers to expedite the review process.
In addition to drug safety, Makary would inherit ongoing projects at the FDA initiated by outgoing Commissioner Robert Califf, including the reorganization of the agency’s food division and the regulation of artificial intelligence in medical technology. However, Makary’s agenda may face opposition from career staffers and industry stakeholders who benefit from the current regulatory framework.
Despite these challenges, Makary’s nomination signals a potential shift in the FDA’s approach to public health and drug regulation, with a focus on transparency, accountability, and patient safety. As the Senate considers Makary’s confirmation, the future of the FDA under his leadership remains uncertain.
