Overdue

Not too long ago, an opinion piece, or oped, ran in JAMA, the Journal of the American Medical Association. It was written by Martin Makary, MD, who was appointed as commissioner of the FDA, or Food and Drug Administration, by President Trump. I would like to share Dr. Makary’s thoughts with you. A few years ago, I wrote a column in this paper about this subject.

If, like me, you watch the evening news on TV, you are bombarded with pharmaceutical ads. This is called direct-to-consumer advertising, or DCA. The U.S. is one of only two countries in the world that allow it. Per Dr. Makary, DCA has evolved into a public health crisis that demands immediate action by the FDA. For nearly three decades, pharmaceutical companies have exploited weak enforcement, flooding U.S. consumers with promotional content that is often misleading. In 1997, a regulatory change by the FDA made these advertisements more widespread by relaxing restrictions, unleashing a marketing free-for-all. Within a decade of this change, pharmaceutical advertising spending increased by nearly 800%, with many ads creating a misleading impression, plus the doctor-patient relationship has become distorted, creating increased demand for medications regardless of clinical appropriateness.

Under the Federal Food, Drug, and Cosmetics Act, the FDA is charged with regulating all prescription drug ads to ensure they represent a “fair balance” of risks and benefits and do not create a “misleading impression.” The FDA’s enforcement trajectory demonstrates a regulatory collapse over the past 25 years. In the late 1990s, the agency sent hundreds of enforcement letters annually to companies violating advertising regulations. By 2023, this number had plummeted to just 1 letter. In 2024, the FDA did not send even one letter. That is about to change. There’s a new sheriff in town.

Misleading impressions come straight from the ads themselves: glossy scenes of patients laughing, singing, and dancing dominate the screen, while fine print races past with warnings about seizures, addiction, and even death. That’s not fair balance – it is distraction by design. A 2023 study demonstrated that DCA drove approximately 31% of the increase in U.S. drug spending since 1997. Companies are spending billions creating increased demand for medications, while patients face a financial burden from unnecessary prescriptions. A 2021 systematic review concluded the DCA increases overall prescription requests, boosts the likelihood that a clinician will prescribe, and increases the rate of inappropriate use, often leading physicians to prescribe medications requested by patients even when they as prescribers question the clinical appropriateness.

Pharmaceutical advertising on social media is even worse. One analysis found that 1,800 social media advertisements from 15 telehealth companies promoted prescription drugs without warnings or risks, including at least 800 advertisements promoting controlled substances. Drug ads on social media are often presented as entertainment, blurring the boundaries between editorial content, user-generated media, and pharmaceutical advertising. Per Dr. Makary, one of the most brazen breaches of FDA regulations was earlier last year when Hims & Hers ran a Super Bowl ad highlighting the benefits of GLP-1 drugs (i.e. Wegovy) without any mention of side effects or dangers.

The FDA cannot ban drug ads – that is prohibited by the First Amendment. But it doesn’t prohibit deceptive and misleading ads that have flooded the media. The FDA will no longer tolerate deceptive practices that distort the doctor-patient relationship and waste billions of dollars in health care resources that could be better spent lowering drug prices for Americans. Like I said, overdue.

Please direct questions and comments to editor@rockawaytimes.com