The Food and Drug Administration (FDA) Reauthorization Act (FDARA) of 2017 was officially signed into law on Friday by President Donald Trump. The move means that the medical products industry will continue to be required to pay fees to the FDA for new drug applications, among other things, for the next five years.
These fees help to fund the FDA’s activities, including assessing the efficacy and safety of new drugs and medical devices, and ensuring the timely review of these products. This was also the first time that the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) were approved.
The bill was passed in the Senate by a vote of 94-1, before being passed to the White House for President Trump’s signature. Senator Bernie Sanders was the only one who opposed the legislation because it didn’t address the drug pricing issue.
“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,” said Health and Human Services (HHS) Secretary Tom Price. “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.”
As a whole, the pharmaceutical industry expressed support for the reauthorization of user fees. If the FDARA were not passed, FDA staff would have been laid off as of the end of September when the existing user fee agreements would have expired.
“PhRMA commends President Trump for signing into law the FDA Reauthorization Act of 2017 (FDARA), which includes the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), as well as the biosimilar and generic drug user fee amendments,” said Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl. “By reauthorizing PDUFA and the other user fees, the administration is leading the way toward greater efficiency at the US Food and Drug Administration (FDA) and increasing competition in the biopharmaceutical market.”
The FDA was similarly encouraged by the passage of FDARA, and published a post on its blog, FDA Voice, detailing how the legislation will help the regulatory agency continue to perform its important role. In addition to the user fees collected from pharmaceutical, medical device and biologics companies, the FDA also receives funding from the US government.