Decisions by PBMs and health plans to shift #generics to non-generic tiers increases copays and imposes higher costs on patients. THE BOTTOM LINE: U.S. patients are overpaying for medicines because of PBMs. Learn the facts: https://accessiblemeds.org/resources/blog/2024-savings-report #GRxBiosimsSavingsReport (fb)

Today, #AAM commented on staffing cuts at the Food and Drug Administration, including key personnel responsible for programs funded by user fees from #generic and #biosimilar manufacturers. A strong and efficient FDA is essential to ensuring the availability of safe and effective affordable medicines for America’s patients—medicines that have saved the U.S. healthcare system over $3 trillion in the past 10 years. Today’s staff reductions may undermine the Agency’s ability to approve and ensure the safety of lower-cost #generics and #biosimilars. The sustainability of the generic industry in the U.S. is already threatened due to increasingly consolidated purchaser markets, unsustainably low reimbursement levels, and continued threats to new launches from patent games by brand drug manufacturers. A decrease in the expertise and capacity within the FDA to review and approve generic and biosimilar medicines will severely and broadly impact patient care. “AAM is deeply concerned by reports that key officials within the FDA’s generic drug and biosimilar programs and officials responsible for administering the industry user fee programs were let go from the Agency,” said John Murphy III, President and CEO of AAM. “While we support improving FDA efficiency to deliver more affordable generic and biosimilar medicines to patients faster, many of the reported cuts appear to do the opposite." U.S. Department of Health and Human Services (HHS) Biosimilars Council #publichealth #healthcare READ: https://accessiblemeds.org/resources/press-releases/aam-comments-on-staff-layoffs-at-fda/ (fb)