News
October 28, 2024: DOJ hands down indictments and patients harmed by formulary change
Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.
[...]A DSCSA-newbies guide to the recent FDA DSCSA announcement
The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.
[...]October 21, 2024: PSM advisory board member leads petition for tariffs over fentanyl precursors from China
Family advocates petition the Office of U.S. Trade Representative to take trade action over Chinese fentanyl precursors. The New York Times tackles PBMs and pharmacy deserts.
[...]FDA Alert: Pain Relief-Marketed Dietary Supplement Recalled For Containing Prescription Steroids, Muscle Relaxants, and OTC Pain Relievers
Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.
[...]October 15, 2024: FDA issues new DSCSA guidance
The FDA granted exemptions for certain trading partners and small dispensers to avoid supply chain disruptions. Stories from the week in counterfeit medicine news.
[...]PSM Advocates for SHOP SAFE legislation at Anti-Counterfeiting Day on the Hill
Our Executive Director, Shabbir Safdar, along with PSM members, shared examples of pharmaceutical counterfeits and helped attendees understand why current systems for stopping counterfeit product sales do not work well.
[...]October 7, 2024: DEA warning – Dozens of fake online pharmacies sold millions of fake pills to customers in all 50 states
An indictment by the Department of Justice against 18 individuals who allegedly sold counterfeit pills via dozens of fake pharmacy websites to residents in all 50 states prompts warnings from two additional federal agencies.
[...]September 30, 2024: 27 individuals indicted in Puerto Rico over wholesale distribution of misbranded and diverted medicine
Twenty-seven people in Puerto Rico indicted in misbranded and diverted drug case, CBP seized counterfeit and misbranded drugs in two states, and fake arthritis and cancer medications seized in India.
[...]PSM Compounded Weight Loss Drugs Poll
PSM commissioned a survey about compounded diabetes and weight loss injectable drugs. 1,000 likely voters across political affiliations were crystal clear — they are worried about safety and the current lack of oversight. See the full results.
[...]September 23, 2024: Administrative complaint filed alleging insulin price inflation by pharmacy benefit managers
The Federal Trade Commission issued an administrative complaint against the three largest pharmacy benefit managers, alleging that the companies used their market power to inflate the cost of insulin for U.S. patients.
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