While it is not uncommon for pharmaceutical and biotechnoogy companies to receive warnings letters from the FDA for various reasons, the issuing of around 100 letters recently could be the clearest indication yet that the agency under Commissioner Marty Makary is taking a strong stand regarding drug marketing and advertising.
In a Sept. 9 news release, the agency said it was launching a “crackdown on deceptive drug advertising.”
“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness,” Makary said. “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”
Eli Lilly, one of the largest drug companies in the world, was issued three letters dealing with promotion of its medications, Zepbound and Mounjaro, which both contain the same active ingredient, tirzepatide, and are approved for, respectively, weight loss and type 2 diabetes.
Novo Nordisk (NVO), Lilly’s rival in the obesity and diabetes space, was issued a letter over its participation in an Oprah Winfrey special on weight loss. One of Lilly’s letters was regarding its part in the special.
Aytu BioPharma (NASDAQ:AYTU), was issued two letters for false and miselading caims regarding Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) and Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets. In both cases, the agency said that sponsored links “create a misleading impression about the safety and efficacy” of the two meds.
Telehealth providers are also being targeted by the FDA. Hims & Hers Health (NYSE:HIMS) received a letter over its marketing of compounded semaglutide, the weight loss and type 2 diabetes drug marketed under the brand names, respectively, Wegovy and Ozempic, by Novo.