Policy/Enforcement News
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.
[...]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.
[...]Prescription Drug Affordability Board Activity through August 15, 2024
Colorado clarifies who their Upper Payment Limit rule applies to. Maryland picks six drugs to conduct cost reviews for and requests information from the public in an effort to produce something by year end. Oregon pauses affordability reviews for 2024 while it gathers feedback from stakeholders. Washington considers the eligibility criteria for drugs to be reviewed, looking to states like Colorado for guidance.
[...]Prescription Drug Affordability Boards
Prescription Drug Affordability Boards States across the country are experimenting with Prescription Drug Affordability Boards (PDABs) to address the price of medicine. Each state has a different approach. Several exist to negotiate supplemental Medicaid rebates; others make recommendations to limit costs. A third group of PDABs is particularly concerning because they have the power to…
[...]PSM testimony: Colorado Prescription Drug Affordability Board Meeting, June 7, 2024
A Colorado board is considering setting a price limit on the medicine Stelara. This will have unintended consequences, undermining the safety of the supply chain for this medicine and limiting patient access. Learn more by reading our testimony.
[...]How Upper Payment Limits on medicine increase the risk of diverted and counterfeit medicine in the drug supply
States like Colorado are experimenting with Prescription Drug Affordability Boards to address the price of medicine, but solutions like Upper Payment Limits will yield multiple unintended consequences that will do more harm than good to patients.
[...]A peek inside a prescription drug diversion ring
The indictment and pre-sentencing memo from the Southern District of New York’s prosecution of Boris Aminov offer a “how-did-they-do-it” guide to prescription drug health care fraud, capturing text messages, crime photos, and a step-by-step guide to the deceit.
[...]Alternative funding programs offshore patients and import risks
Some employers are “saving money” on health insurance by hiring vendors to broker personal drug importation between their employees and unlicensed, illegal foreign pharmacies. Read more to understand the dangers of this cost-cutting practice.
[...]Threat Alert: Medicine designed to mimic regulated pharmaceuticals for sale online at Etsy.com
In spite of Etsy’s terms of use, there is a thriving trade in chemicals on the site, including those sold to individuals seeking homemade versions of highly regulated pharmaceuticals.
[...]How low PBM reimbursements ultimately endanger US patients
Pharmacy benefit managers have created an economic climate that encourages the sale of fake and diverted medicines by systematically under reimbursing pharmacies.
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