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WASHINGTON — The Association for Accessible Medicines issued a statement regarding today's staffing reductions at the Food and Drug Administration, which affect essential personnel managing programs financed by user fees from generic and biosimilar manufacturers.
Thorvardur de Shong
“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.”
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 generic and biosimilar medicines.
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.
Murphy continued, “On behalf of our members and the health of America’s patients, we look forward to engaging with the newly confirmed Commissioner Makary to address our concerns and to continue advancing reforms that strengthen the FDA’s efficiency, resiliency, and commitment to quality.”
