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RFK Jr vow to purge FDA sets up collision with Big Pharma

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The FDA Under Fire: Robert F. Kennedy Jr.’s Ambitious Agenda

Robert F. Kennedy Jr. has vowed to purge the U.S. Food and Drug Administration (FDA) shortly before being chosen as President-elect Donald Trump’s nominee for health secretary. Any changes he wants to make will come up against a pharmaceutical industry that pays much of the regulator’s bills.

Kennedy’s Agenda

Kennedy, an environmental activist who has helped sow doubts about the safety and efficacy of vaccines, would have authority over the nation’s agencies responsible for public health, government-funded health insurance plans for more than 140 million people, including the poor, those 65 and older, and the disabled, medical research, and more if confirmed as U.S. Secretary of Health and Human Services.

Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food, and tobacco products. In interviews and on social media, Kennedy has accused agency staff of doing the bidding of Big Pharma and Big Food.

Industry Reactions

Shares of vaccine makers, including Pfizer Inc. and Moderna, fell after news of Kennedy’s appointment and were down in after-hours trading by as much as 2%. The Pharmaceutical Research and Manufacturers of America, the leading industry lobby group, said in a statement that it wanted to work with the Trump administration to improve health for patients.

Del Bigtree, who was director of communications for Kennedy’s election campaign and remains close to the former candidate, said he expected a careful look at any FDA employee ties to industry.

FDA Funding

In 2024, $3.3 billion, almost 46% of the agency’s $7.2 billion budget, came from so-called "user fees," or payments made by pharmaceutical and medical device manufacturers to fund the staff resources needed to review their products quickly, conduct inspections, and ensure the safety of clinical trials. The FDA says user fees do not influence its decisions to approve products, and its overall budget is still subject to Congressional approval.

Industry Concerns

Pharmaceutical executives have tried to mitigate concerns over Kennedy’s potential influence, and stressed the importance of the agency’s scrutiny of the safety and efficacy of life-saving medications for everything from cancer to diabetes and heart disease.

The Future of the FDA

Dan Troy, former chief counsel at the FDA under Republican President George W. Bush’s first administration, said he did not expect any "seismic changes." Even if Kennedy and other political appointees were able to fire a substantial number of staff, "who are you going to put in place? Who has the technical expertise to write these rules that are going to really change the paradigm?" he said.

Conclusion

The appointment of Robert F. Kennedy Jr. as President-elect Donald Trump’s nominee for health secretary has raised concerns about the future of the FDA. Kennedy’s history of questioning the safety and efficacy of vaccines has led to concerns about his ability to lead the agency effectively.

FAQs

  • What is the FDA’s role in the healthcare system?
    The FDA is responsible for ensuring the safety and efficacy of medicines, food, and tobacco products in the United States.
  • What is the pharmaceutical industry’s relationship with the FDA?
    The pharmaceutical industry pays user fees to the FDA to fund the agency’s work in reviewing and approving their products.
  • How does Kennedy’s appointment impact the FDA?
    Kennedy’s appointment as President-elect Donald Trump’s nominee for health secretary has raised concerns about the future of the FDA and its ability to effectively regulate the pharmaceutical industry.
  • What are the potential consequences of Kennedy’s appointment?
    The potential consequences of Kennedy’s appointment include a purge of FDA staff, changes to the agency’s funding structure, and a shift in the agency’s priorities and policies.
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