U.S. lawmakers are considering a legislative proposal that would reauthorize the Prescription Drug User Fee Act (PDUFA) and potentially drive innovation in the pharmaceutical industry and among regulators.
The legislation has proven to be a bipartisan initiative that could empower pharmaceutical and device companies to have greater flexibility while making user fees policies that are patient oriented.
Cynthia Bens, vice president of public policy for the Alliance for Aging Research, told Patient Daily that the PDUFA reauthorization is the next step in a long process
“Like past prescription drug user fee program reauthorizations, the PDUFA VI agreement, currently under consideration by the House and Senate, provides the U.S. Food and Drug Administration (FDA) with the resources and expertise necessary to assess the safety and efficacy of drugs in a timely manner,” Bens said. “PDUFA VI builds on progress made through the PDUFA V reauthorization and passage of the 21st Century Cures Act to put the needs of patients at the center of drug development. Enhancements in PDUFA VI emphasize the importance of understanding the needs of patients and their caregivers and focus on integrating this information into clinical trial design and regulatory decision making.”
House Subcommittee on Health Chairman Michael Burgess (R-TX) said action on the reauthorization bill couldn’t have come at a better time in the legislative process.
“Today’s markup is just the latest step in nearly two years of work by the biopharmaceutical and medical device industry, the Food and Drug Administration and Congress,” Burgess said in a press release. “It is a bipartisan and bicameral priority to complete this work and reauthorize the user fee programs in a timely manner.”
House Energy and Commerce Committee Chairman Greg Walden (R-OR) echoed similar sentiments.
“Let me be clear: if we do not have this bill to the president’s desk in July, not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients,” Walden said in the release. “We cannot – and will not – stand for that.”
If Congress fails to pass and send the reauthorization bill to the desk of President Donald Trump, major cuts will in ensue and operations for the agency will be limited in its operations.