Congress Passes FDA User Fee Legislation

Aug. 7, 2017 – In a 94-1 vote, the U.S. Senate on Aug. 3 passed FDA user fee reauthorization legislation that will revise and extend the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through 2022. H.R. 2430, the FDA Reauthorization Act of 2017, was passed by the House in July.

“Congress did its job passing the FDA user fee legislation and avoided distracting amendments that would have delayed passage. Thanks to FDA, industry and public participants for working together to make it possible to keep the staff at FDA sufficient to meet its public health mission,” noted Coalition for Healthcare Communication Executive Director John Kamp.

The bill now goes to President Donald J. Trump, who is expected to sign it into law, even though his 2018 budget proposal called for user fee increases.

Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl called the passage of the user fee legislation “a major victory for medical innovation, the FDA and patients.” In a statement, Ubl said that “PhRMA applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts. PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the [FDA] with new tools and resources to keep up with the latest scientific advances.

“By strengthening the FDA and improving efficiency in the drug review process,” Ubl said, “we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs.”

Following the passage of the user fee legislation, Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood said: “The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.

Another bill, the Right to Try Act, passed the Senate earlier the same day (S. 204). That bill, which is headed to the House, would expand the access that patients with terminal illness have to experimental treatments. Further, a bipartisan bill addressing the opioid epidemic (S. 581), was passed by the Senate Aug. 3 as well. This bill, which will now go to the House, would direct the FDA to establish protocols for including information concerning a patient’s opioid addiction in certain medical records.