FDA Cracks Down on Telehealth Companies Over Compounded Obesity Drugs,Drug Advertising
WASHINGTON – The Food and Drug Management is intensifying its scrutiny of telehealth companies and pharmaceutical advertising,issuing recent warning letters to firms including Hims and AstraZeneca,signaling a broader effort to regulate direct-to-consumer drug promotion and the burgeoning market for compounded medications.
The FDA’s actions center on two key areas: the marketing of compounded versions of GLP-1 drugs-originally intended for diabetes but increasingly used for weight loss-and the presentation of drug side effects in television advertisements.
While the FDA initially permitted “compounding,” or customized drug production, to address a shortage of FDA-approved GLP-1 medications, the agency recently persistent a shortage no longer exists. Compounding is now only permissible when a prescription is specifically tailored to an individual patient’s needs. However, companies like Hims have been offering “personalized” dosages and formulations, claiming additional benefits. The FDA’s letters challenge this practice.
Separately, the FDA took issue with a television advertisement for AstraZeneca’s FluMist vaccine, stating that ”background music and visual distractions” undermined clear interaction of potential side effects. The letter, signed by FDA vaccine chief Dr. Vinay Prasad, came after his recent return to the agency following a brief administrative leave.
The FDA’s move follows long-standing concerns from researchers and consumer advocates that upbeat imagery in drug ads frequently enough overshadows crucial information about risks. Studies have also indicated that exposure to such advertising increases patient requests for medications, even when they don’t meet prescribing criteria. The American Medical Association supported a ban on direct-to-consumer television drug advertising in 2015, citing its role in driving demand for newer, more expensive medications.
