Policy/Enforcement News
Case overview: Eli Lilly and Co v InstantRx, et al (2026 — ) – ongoing
Eli Lilly filed a complaint against InstantRx and other defendants that allegedly distributed counterfeit and/or misbranded versions of Lilly-branded medicines through online pharmacy to pharmacy marketplaces.
[...]Update on drug importation, October 2026
Well-meaning advocates continue to propose importing medicine from foreign countries to lower drug prices for Americans. Past efforts didn’t pay off financially and raised public health risks. Here’s the state of this issue today.
[...]Pill press update: February to July 2026
Between February and July, the media covered pill press seizures in 13 states and customs forfeiture records reported seizures of 16 pill presses, six capsule-filling machines, and over 300 pill press parts, dies, and molds. Learn more about the last six months in pill press news.
[...]Mass drug compounding poses serious risks to patients
Drug compounding is intended to meet individual patient needs or temporarily bridge shortages — but the GLP-1 market has broken that model. T
[...]Key takeaways from PSM’s Axios event: Examining risk and regulation in the compounded GLP-1 landscape
SAFE Drugs Act sponsor Rep. Rudy Yakym (R-IN), Rep. Nikki Budzinski (D-IL), leading obesity medicine specialist Dr. Scott Kahan, and PSM Executive Director Shabbir Imber Safdar. delivered a clear message: Compounded substances are not the same as FDA-approved medications, and treating them as such undermines patients’ safety.
[...]PSM joins PSI, Rx360 and PDSA in letter urging FDA to protect the traceable drug supply
PSM joined three other organizations for a sign-on letter explaining our concerns that unrestricted mass compounding increases the untraceable drug supply. An explosion of 503B compounding of these three substances, semaglutide, tirzepatide, and liraglutide, would dramatically increase the compounded medicine supply which is not serialized, and therefore, not traceable.
[...]PSM submits comment supporting the continued exclusion of GLP-1s from the 503B Bulks List
PSM supports the FDA’s proposal, which will help protect patient safety and the integrity of the drug approval process.
[...]Joint statement on warning to pharmacists about diverted HIV medicines being sold on online pharmacy-to-pharmacy platforms
ADAP Advocacy and the Partnership for Safe Medicines (PSM) issued the following joint statement as a warning to pharmacists that all discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces fit the definition of suspect product under U.S. Food and Drug Administration (FDA) guidelines and the Drug Supply Chain Security Act.
[...]Pharmacists beware: Diverted HIV medicines are being sold on online pharmacy-to-pharmacy platforms
The Partnership for Safe Medicines and ADAP Advocacy are warning that discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces qualify as suspicious products under U.S. Food and Drug Administration guidelines and the Drug Supply Chain Security Act. Given the risks, we believe that it isn’t safe or cost-effective to purchase HIV products from these platforms.
[...]Peptide therapies — popular, unproven, dangerous
Americans have become accustomed to taking peptides for for improved health, but unless they’ve undergone clinical trials and received FDA approval, there’s no way to establish a peptide’s safety or effectiveness.
[...]