Florida’s Public Health Integrity Committee (PHIC), led by State Surgeon General Dr. Joseph A. Ladapo, met this week to address concerns about the United States Food and Drug Administration’s (FDA) drug approval process and oversight of pharmaceutical advertising.
The committee raised issues about the FDA’s two-tier review system, which allows for expedited approval pathways such as “Accelerated Approval,” “Breakthrough Therapy,” “Fast Track Program,” and “Priority Review.” These programs can enable earlier approval of drugs that treat serious diseases or fill unmet needs but may also allow some drugs to bypass traditional clinical trial requirements. The PHIC noted that almost two-thirds of the FDA’s medical product budget now comes from industry fees, raising questions about potential conflicts of interest and whether patient safety is being prioritized.
Examples cited included the approval of extended-release oxycodone based on limited clinical data and subsequent broad labeling that allowed for widespread prescribing. The opioid crisis was highlighted as an example of risks when safety standards are not rigorously enforced. Oncology therapeutics were also discussed, with concerns that approvals are sometimes based on surrogate endpoints such as tumor size rather than patient survival or quality of life. The committee pointed out it can take years for harmful or ineffective cancer treatments to be withdrawn from the market.
The PHIC further discussed the federal response to COVID-19, noting a lack of transparency following the approval of mRNA vaccines by Pfizer and Moderna. Both companies were instructed to conduct studies on subclinical myocarditis but have not released results or updated advertisements with information on established risks.
Another concern involved drug recalls. Since 2012, there have been more than 15,000 drug recalls in the United States—an average exceeding three per day. Recent examples include over-the-counter cold medications containing oral phenylephrine, which were recalled decades after their initial approval due to new evidence indicating ineffectiveness. Makena, a drug intended to reduce preterm birth risk, was removed from the market 20 years after being found ineffective and associated with increased risks.
On pharmaceutical advertising, PHIC members highlighted that prescription drug ads in the U.S.—one of only two countries allowing direct-to-consumer marketing—are not reviewed for accuracy before reaching consumers. An FDA survey indicated about 75 percent of physicians believe these ads lead patients to overestimate a drug's effectiveness and pressure providers into prescribing them. Although disclaimers are required, ads can reach audiences immediately upon a drug’s approval without prior FDA review.
To inform Floridians about these processes, PHIC has created infographics explaining both drug approval and advertising pathways.
“I want to thank all of our PHIC members for joining us today and for their continued dedication to preserving the health and well-being of all people,” said State Surgeon General Dr. JosephA. Ladapo. “Florida will continue to fight for truth and scientific integrity.”
“The primary problem that we are seeing with the FDA is that it’s moving away from science when approving medications,” said Dr. Linda Wastila. “Relying on application fees and surrogate end points only further enables the revolving door of the pharmaceutical industry self-regulating itself.”
“The United States is in desperate need of a regulatory agency which prioritizes human health over pharmaceutical industry profits. One critical step in achieving this will be increased transparency from the FDA,” said Dr. Tracy Beth Høeg. “Raw, de-identified data from vaccine and pharmaceutical trials should be made available to the public. Timely information should be provided to the public on post-marketing surveillance studies as well as vaccine and drug product side effects. Finally, prior to drug and vaccine approval by the FDA, clinical trials should determine if the benefits of the medical products outweigh the risks for the population they are intended to be used in.”
“We saw in the COVID-19 pandemic how some exceptions, when abused, led to the harm of patients rather than their health and well-being,” said Dr. Jay Bhattacharya. “Rather than allowing pharmaceutical companies to conduct their own safety assessments, the FDA should conduct very rigorous phase 4 clinical trials.”
“Surrogate end points allow Big Pharma to avoid conducting proper clinical trials indefinitely,” said Dr. Joe Fraiman. “By continuing to expedite the regulatory approval process, the FDA is robbing Americans of the health and well-being they deserve.”
“The federal government should place a much heavier emphasis on phase 4 clinical trials,” said Dr. Christine Stabell Benn. “By taking the safety analyses out of the pharmaceutical industry’s hands, the FDA will be able to conduct the proper rigorous standardized trials that are necessary.”
“Unfortunately, due to the FDA growing more lackadaisical, the pharmaceutical industry does not carry the same reputation that it used to,” said Dr. Martin Kulldorff. “The conflicts of interest at bay are directly linked to political influences and the incredible amount of money circulating within the industry, leading to a complete lack of accountability.”
The Florida Department of Health states its mission is protecting and improving public health through integrated state, county, and community efforts.