Partnership for Safe Medicines statement on weight loss drug ad blitz

Shabbir Safdar, executive director of the Partnership for Safe Medicines, released the following statement in response to the advertisement that lifestyle brand Hims & Hers released ahead of the Super Bowl to sell unregulated compounded weight loss drugs:

“The upcoming Super Bowl has its first penalty flag, and this foul recklessly misleads and potentially endangers the more than 100 million Americans who will be watching next Sunday.

“As a leading patient-safety watchdog, the Partnership for Safe Medicines is deeply disturbed by the advertisement for ‘weight loss drugs’ that lifestyle brand Hims & Hers released this week ahead of the Feb. 9 game. Heavy on hyperbole and light on ethical transparency, this marketing blitz promotes altered, poorly regulated versions of legitimate pharmaceutical medications – also known as compounded drugs – intended for people living with serious medical conditions, including diabetes and obesity.

“For those unfamiliar, compounded drugs have a role to play in medicine, but they can present significant health risks – particularly with complex injectable products like Hims & Hers is advertising. They are not FDA-approved, tested, or inspected like a typical drug manufacturer, and a string of recent incidents reinforces PSM’s concerns. Some compounders have used unauthorized substances in their products.

“The FDA says compounded drugs are a last resort for patients during a shortage and should never be the first choice in therapy. But the many millions of people who tune into the Super Bowl won’t learn that from this ad.

“Typical pharmaceutical ads must follow strict guidelines about sharing a drug’s side effects and risks to inform and protect patients. Compounders operate on the outskirts of drug safety regulations and don’t face the same stringent requirements. This ad exploits the loophole in existing law, prioritizing shock value and sales targets.

“The trade association for compounders, the Alliance for Pharmacy Compounding, recognizes how flashy ads with overstatements can deceive and endanger. The trade group’s Best Practices for Marketing Compounded Medications instructs members to avoid making misleading safety claims, particularly for drugs without FDA approval. With no clear mention of the risks of these medications, this direction was ignored completely.

“The pharmaceutical practice of compounding can help in individual circumstances, like allergies to a drug ingredient or in emergency shortages. But nationwide ads encouraging millions of people to buy and consume compounded injectables that aren’t FDA-approved undermines public health and safety.

“Some penalty flags during the Super Bowl might be debatable. This one isn’t. The ad undermines trust in responsible health care by putting business ahead of ethics, transparency, and safety.”

Click here to view PSM’s resources on compounded weight loss drug safety. For media inquiries, please contact editors@safemedicines.org.

####

About the Partnership for Safe Medicines

The Partnership for Safe Medicines is a public health group committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines. Comprised of more than 45 non-profit organizations, PSM studies counterfeit drug crime, threats to American patients, and educates the public, policymakers, and health care professionals about threats to the safety of the U.S. drug supply.