(Reuters) -U.S. Food and Drug Administration Commissioner Martin Makary said on Friday that Hims & Hers’ Super Bowl advertisement breached federal law as it highlighted the benefits of weight-loss drugs without mentioning side effects. Under federal law, prescription drug ads must present a “fair balance” of risks and benefits, Makary said in JAMA, a peer-reviewed medical journal published by the American Medical Association.
He said the FDA used to issue hundreds of warning letters annually in the late 1990s compared with just one in 2023 and none in 2024. The U.S. is one of only two countries globally that allow direct-to-consumer (DTC) pharmaceutical advertising, Makary said.
This follows Donald Trump signing a presidential memorandum on Tuesday, urging his administration to strengthen enforcement of DTC pharmaceutical ad regulations to ensure transparency and accuracy.
On the same day, the FDA said it would issue around 100 cease-and-desist enforcement notices and thousands of warning letters to pharmaceutical companies, reminding them to adhere to advertising rules.
Hims & Hers did not immediately respond to a request for comment. It had aired an ad during the Super Bowl in February showcasing its compounded versions of Novo Nordisk’s Wegovy.
U.S. regulations permit compounding pharmacies to replicate brand-name drugs during periods of shortage. Wegovy had seen significant supply constraints in the country last year.
Americans unable to afford Wegovy or facing difficulties obtaining it have turned to lower-cost options offered by pharmacies and telehealth providers such as Hims & Hers and WeightWatchers.
“Online pharmacies are advertising drugs with only upsides mentioned, contributing to America’s culture of over-reliance on pharmaceuticals for health,” Makary said, adding that the Hims & Hers ad was the most overt breach of FDA’s regulations on advertising.
(Reporting by Puyaan Singh in Bengaluru; Editing by Mohammed Safi Shamsi)
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