Statement on Timing of FDA User Fee Reauthorization (FDARA) | Association for Accessible Medicines
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Statement on Timing of FDA User Fee Reauthorization (FDARA)

WASHINGTON, DC (AUGUST 1, 2017) – The Association for Accessible Medicines (AAM) urges the United States Senate to consider and pass the FDA Reauthorization Act of 2017 (FDARA) as soon as possible. We are encouraged by Majority Leader Mitch McConnell’s (R-KY) remarks earlier today that he wants his colleagues to complete action on the FDARA before the Senate begins its August recess.

There is terrific momentum for policies and processes that will increase competition and bring down drug costs, so any delay now by Congress could upend those efforts. The Trump Administration and its FDA Commissioner, Dr. Scott Gottlieb, are taking a big step forward to enhance the FDA’s approval process to bring more safe, effective and affordable generic and biosimilar medicines to market. Congress can now do its part to advance meaningful progress by reauthorizing GDUFA, as well as take the critical action that they alone must take to pass the CREATES Act which curbs anti-patient and anti-competitive abuses by some brand drug manufacturers.