April 22, 2022 – Vizient, Inc. provided comments and feedback to Congress on the Food and Drug Administration’s (FDA) draft agreements for the next iteration of the Medical Device User Fee Act (MDUFA) and the Prescription Drug User Fee Act (PDUFA). MDUFA and PDUFA authorize FDA to collect user fees to support FDA’s review of medical devices and prescription drug applications, respectively, and improve the efficiency of FDA’s regulatory processes.
As Congress undertakes MDUFA reauthorization efforts, Vizient encouraged lawmakers to consider expanding the FDA’s authorities to promote greater transparency and industry information sharing about device sourcing, manufacturing and finishing to mitigate shortages and other medical supply chain challenges.
Vizient also urged Congress to take steps to protect against medical device cybersecurity threats by including the bipartisan Protecting and Transforming Cyber Health Care (PATCH) Act to ensure device security and effectiveness. For PDUFA, Vizient encouraged Congress to make statutory changes to encourage the completion of more clinical investigations for legacy drugs undergoing approval.
“Vizient remains a strong advocate for innovation and patient access to safe and effective medical devices and prescription drugs,” said Shoshana Krilow, senior vice president of public policy and government relations for Vizient. “Timely reauthorization of all of the User Fee Acts is critical to ensuring such efforts continue without disruption.”
While supportive of a timely reauthorization, Vizient continues to urge Congress to take steps to provide greater transparency to support a more resilient health care supply chain and advance policies that foster competition for prescription drugs and medical devices.