Article Topic
JAMA Personal Drug Importation Correction
PSM’s executive director submitted the following correction to the Journal of the American Medical Association (JAMA) in December 2024: International online pharmacies are illegal, and an unacceptable cost-saving strategy Shabbir Safdar Executive Director, The Partnership for Safe Medicines JAMA’s October 21, 2024 Special Communication, “Strategies to Help Patients Navigate High Prescription Drug Costs,” by Hussain…
[...]Government’s Restitution Memo, USA v Lorik Papyan
United States District Court Northern District of California USA v Lorik Papyan Government’s Restitution Memo Filed November 4, 2024 Read the document and Gilead Sciences’ Victim Impact Statement.
[...]Order re: Payment of Restitution, USA v Lorik Papyan
United States District Court Northern District of California USA v Lorik Papyan Order re: Payment of Restitution Filed November 22, 2024 Read the document.
[...]November 25, 2024: A new money laundering case is tied to online pharmacies selling counterfeit pills
A California man allegedly processed payments for foreign online pharmacies selling fentanyl and meth pills.
[...]Prescription Drug Affordability Board Activity through November 15, 2024
Colorado’s board reviewed proposed changes to PDAB legislation based on stakeholder testimony and board review and learned about Medicare’s Maximum Fair Price (MFP) determination. Over two meetings, Oregon’s board reviewed a draft constituent group engagement report and a UPL model that analyzed potential 2023 savings based upon MFP provided by their consultants and aggregate data collected from PBMs. The board also discussed ; policy recommendations from staff and a UPL draft report required by Senate Bill 192.
[...]FDA Alert: Dietary Supplement Recalled Due to Presence of Sildenafil and Diclofenac
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
[...]FDA Alert: Dietary Supplement Contains Drug That Can Cause Heart Attack, Stroke and Internal Bleeding
Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
[...]November 11, 2024: Feds pursue companies selling fentanyl precursors
Another China-based chemical company was indicted for allegedly selling precursor chemicals and xylazine to U.S. buyers as Americans continue to grapple with the toll of counterfeit prescription pills made with dangerous drugs.
[...]Indictment, USA v Hubei Aoks Bio-Tech Co and Xuening Gao et al
United States District Court Central District of Calfornia USA v Hubei Aoks Bio-Tech Co and Xuening Gao et al Indictment Filed May 10, 2024 Read the document.
[...]FDA Alert: Compounding Pharmacy in California Warned After Particulates Found in Injections
On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.
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