Introduction to FDA’s Crackdown on Telehealth Services
The Food and Drug Administration (FDA) has taken a significant step in regulating telehealth companies that promote unofficial versions of prescription drugs. This move is part of the Trump administration’s broader effort to crack down on pharmaceutical advertising. The FDA posted over 100 letters to various drugmakers and online prescribing companies, including Hims & Hers, warning them to remove "false and misleading" promotional statements from their websites.
Background on Hims & Hers
Hims & Hers has built a multibillion-dollar business centered around lower-cost versions of blockbuster obesity injections. The company’s website claimed that its customized products contain "the same active ingredient" as FDA-approved drugs Wegovy and Ozempic. However, the FDA warned Hims to remove these claims, stating that they imply the products are the same as FDA-approved products when they are not. The formulations cited by regulators are produced by specialty compounding pharmacies and aren’t reviewed by the FDA.
FDA’s Warning Letters
The FDA’s warning letters to Hims and other companies mark the first time the agency has directly policed online platforms like Hims. The letters contain "cease and desist" language, a different approach for the agency, which typically drafts its letters in highly bureaucratic language citing specific FDA regulations. Hims said it "looks forward to engaging with the FDA" and noted that its website and customer-facing materials indicate that compounded treatments are not approved or evaluated by the FDA.
Regulation of Pharmaceutical Ads
The FDA also posted separate warning letters to manufacturers of GLP-1 drugs, taking issue with a 2024 infomercial featuring Oprah Winfrey. Regulators said the 42-minute TV segment from Eli Lilly and Novo Nordisk gave a "misleading impression" about the safety of Zepbound, Wegovy, and similar "drugs with multiple serious, potentially life-threatening risks." Health Secretary Robert F. Kennedy Jr. has long been a critic of the pharmaceutical industry, including GLP-1 drugs, and previously suggested Americans can reverse obesity with diet and exercise alone.
Impact on Telehealth Companies
Hims has been under scrutiny from Washington for some time. Earlier this year, a Super Bowl ad from the company touted the benefits of its weight-loss medications but didn’t list any of their side effects or potential harms. FDA rules require advertisements to present a balanced picture of drug risks and benefits. The company’s shares fell more than 6.47% in trading Tuesday.
FDA’s Approach to Compounding
The FDA permits compounding, or customized production, when there is a shortage of the official versions of FDA-approved medications. However, the FDA recently determined that GLP-1 drugs no longer met the criteria for a shortage. That should have ended the compounding, but there is an exception: the practice is still permitted when a prescription is customized for the patient. Hims and other companies have taken to offering "personalized" dosages and formulations for certain patients, arguing they offer extra benefits.
Conclusion
The FDA’s crackdown on telehealth services and pharmaceutical advertising marks a significant shift in the agency’s approach to regulating online platforms. As the telehealth industry continues to grow, it’s likely that we’ll see more scrutiny from regulatory agencies. The FDA’s efforts to ensure that pharmaceutical ads are truthful and non-misleading are crucial in protecting public health.
FAQs
- What is the FDA’s concern with Hims & Hers?
The FDA is concerned that Hims & Hers is promoting unofficial versions of prescription drugs, including weight loss medications, in a way that is "false and misleading." - What is compounding, and how does it relate to GLP-1 drugs?
Compounding refers to the customized production of medications. The FDA permits compounding when there is a shortage of the official versions of FDA-approved medications. However, the FDA recently determined that GLP-1 drugs no longer meet the criteria for a shortage. - How has the FDA approached regulating pharmaceutical ads in the past?
The FDA has typically drafted its letters in highly bureaucratic language citing specific FDA regulations. However, the recent warning letters to Hims and other companies contain "cease and desist" language, a different approach for the agency. - What is the impact of pharmaceutical ads on public health?
Research has shown that patients exposed to drug ads are more likely to ask their doctors about the medication, even if they don’t fit the prescribing criteria. The American Medical Association has come out in support of a ban on TV advertising, citing its role in "inflating demand for new and more expensive drugs."
