Archive for February 2025
Hims and Hers warns investors about potential liability for FDA-regulated compounded prescription drug ads
There has been controversy about the ad Hims & Hers ran during the Super Bowl. And now an SEC filing says investors should be warned about risk if their ads are found to be non-compliant.
[...]FDA Alert: Dietary Supplement Recalled for Containing Prescription Drug Ingredients
This is a reprint of an FDA Alert.
[...]Prescription Drug Affordability Board Activity through February 25, 2025
Prescription Drug Affordability Board Activity through February 25, 2025 Activities Summary Colorado: Colorado’s PDAB did not meet in February. The next PDAB meeting will be March 7, 2025. Maryland: Maryland’s PDAB did not meet in February. The Board may have ad hoc meetings before its next scheduled meeting on March 24, 2025. Oregon: Board members…
[...]February 24, 2025: PSM report finds 80% of declared, unapproved semaglutide and tirzepatide slipped past customs over 17 months
PSM’s new report shows that unregulated semaglutide and tirzepatide are slipping by FDA and CBP at the border. Semaglutide is no longer in shortage.
[...]New report reveals illegal ingredients for knockoff weight loss drugs flooding into U.S. from foreign sources, endangering patient safety
The Partnership for Safe Medicines today released a new report that found suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity injectables (commonly known as weight loss drugs) are flooding into the U.S. from foreign sources despite U.S. laws forbidding them from coming through the border.
[...]PSM applauds Arkansas Board of Pharmacy for protecting patients
The Partnership for Safe Medicines applauds the Arkansas State Board of Pharmacy for utilizing new product verification technology for identifying illegitimate Ozempic quarantined by a pharmacy this week.
[...]February 10, 2025: NY woman allegedly injected mystery substances instead of Botox
Mystery cosmetic injections allegedly harmed a client in Queens. PSM addressed a misleading drug ad for compounded weight loss medicine.
[...]Over 100 million Americans just watched a misleading ad at the Super Bowl.
You could tell an American that they’re getting a compounded medicine and they would have no idea what that meant. That may be a legal disclosure, but that’s not good enough to protect patients who don’t know what the words mean.
[...]Compounded weight loss injections — knock-offs are not the same
Compounded weight loss injections — knock-offs are not the same Who says legally-compounded versions are not as safe as the FDA-approved products? The Food and Drug Administration. In November 2024, the Food and Drug Administration (FDA) issued “Compounding and the FDA: Questions and Answers,” warning that Compounded drugs should only be used in patients whose…
[...]Letter to FDA’s Office of Prescription Drug Promotion, CDER
PSM sent the following letter to the FDA’s Office of Prescription Drug Promotion (CDER) asking them to enforce the laws and guidelines that protect Americans from misleading advertising in the Hims&Hers Super Bowl ad.
[...]