Policy/Enforcement News
Why are price cap proposals on medicines dangerous to pharmacies and patients?
Supply chain complexity means that upper payment limits and Medicare maximum fair prices will fall disproportionately on pharmacies, leading to closures that threaten patient access to care.
[...]Med spas need stronger regulation
Medical spas and wellness clinics are operating on the edge of existing regulatory frameworks and it’s a risk to American patients.
[...]Prescription Drug Affordability Board Activity, August 2025
Prescription Drug Affordability Board Activity, August 2025 Activities Summary Colorado: Colorado’s PDAB met on August 22, 2025 for to continue rulemaking to set an upper payment limit for Enbrel, during which they heard substantial public comment. They will continue this process at their next meeting on October 3. Maryland: The next PDAB meeting will be…
[...]PSM leads letter in support of an FDA mandate to destroy high-risk imports
PSM led a coalition of organizations urging leaders of the Senate HELP and House Energy and Commerce committees to help strengthen the FDA’s ability to protect Americans from unsafe and counterfeit medicines and medical products.
[...]Prescription Drug Affordability Board Activity, July 2025
Prescription Drug Affordability Board Activity, July 2025 Activities Summary Colorado: Colorado’s PDAB met on July 11, 2025 for a rulemaking hearing to set an upper payment limit for Enbrel, during which they heard substantial public comment. They will continue this process at their next meeting on August 22. Maryland: At its July 28 meeting, Maryland’s…
[...]Tell us about your alternative funding program
Used an alternative funding program? Tell us your story The Partnership for Safe Medicines is researching alternative funding programs. If you are a patient or an administrator, we’d like to confidentially interview you to understand how you have encountered these programs, how they work, and what your experience was. If you’re ready to interview, or…
[...]Final publication of guidelines for online pharmacy-to-pharmacy medicine marketplaces
We’ve published the final document of best practices for online pharmacy-to-pharmacy marketplaces.
[...]What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?
503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.
[...]Prescription Drug Affordability Board Activity, June 2025
Prescription Drug Affordability Board Activity, June 2025 Activities Summary Colorado: Colorado’s next PDAB meeting will be held on August 22, 2025. Maryland: Maryland’s PDAB met on June 23 for updates about federal drug pricing and Maryland’s biotech and life sciences industry. Oregon: At its June 18 meeting, Oregon’s PDAB reviewed survey data and narrowed its…
[...]FDA announces changes to section 804 importation program proposals
A July 1, 2025 post clarifies that applicants can use “a static baseline approach for the cost-savings analysis” instead of trying to account for changes in unpredictable markets.
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