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Congressional User Fees Agreement Marks a Step Forward for Patients and Innovators

We Work For Health Applauds the Reauthorization of the Prescription Drug and Biosimilar User Fee Acts

Washington, DC (Oct. 21, 2022) – We Work For Health Co-Chairs Tom Kowalski and Rolf Benirschke released the following statement in reference to the recent reauthorization of prescription drug and biosimilar user fees.

“We Work for Health commends the efforts of the U.S. Congress in passing critical legislation to reauthorize the prescription drug and biosimilar user fee programs. Reaching this agreement makes it possible for the FDA to continue fulfilling its mission to protect and advance public health, including reviewing new medicines in a timely matter.

“This legislation marks an important milestone. Thirty years ago, Congress enacted the first Prescription Drug User Fee Act (PDUFA) that made possible timely and safe drug approval processes funded through user fees from the biopharmaceutical industry. Today, the U.S. is the global leader when it comes to approval times for new medications. Further, the reauthorization of these acts protects thousands of jobs. The American biopharmaceutical industry supports over 4.4 million jobs both directly and indirectly – everyone from researchers and manufacturers that keep local economies thriving across the country to FDA regulatory staff in Washington.

“This reauthorization serves as a reminder that sound public policy is critical to ensuring that patients have access to high-quality, life-saving and innovative medicines without delay. We will continue to work with Members of Congress and leaders across health care to advance policies that facilitate continued innovation and that eliminate barriers to access.”

About We Work For Health

We Work For Health (WWFH) is a coalition of partners that collaborates with biopharmaceutical research companies, vaccine manufacturers, their employees and local businesses to improve the health and well-being of patients. The program helps to support policies and initiatives that reinforce the delivery of lifesaving advances in medicine while also promoting the critical importance of high-paying jobs and the impact of the biopharmaceutical sector on national, state and local economies.


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