US President signs FDARA into law

On Friday, US President Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized the Prescription Drug User Fee Act (PDUFA) and user fees for biosimilars, generic drugs and medical devices.

The House of Representatives and the Senate each passed the legislation on July 12 and August 3, respectively, and committees in both chambers with jurisdiction over FDA agreed on the final language.

Commenting on the signing, Health and Human Services Secretary Dr Tom Price said: “By signing the FDA Reauthorization Act of 2017 into law, President Trump is ensuring that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs, to generic drugs, biosimilars, and medical devices. The law will support our team at FDA as they carry out the HHS mission to enhance and protect the health and well-being of the American people and continue to advance medical breakthroughs.”