Lawmakers, AdvaMed urge swift passage of FDA user fee reauthorization


During a hearing today on FDA user fee programs, Senator Mike Enzi (R-WY), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee, emphasized the importance of timely authorizing user fee agreements covering drugs, medical devices, generic drugs, and biosimilar products and called for quick passage of the legislation.

“The prescription drug and medical device user fee agreements expire on September 30. Congress must act on this crucial legislation in a timely manner,” said Senator Enzi. “Patients, jobs, and innovation depend on it.”


Senator Mike Enzi

Enzi said he and HELP Committee Chairman Harkin plan to mark up one bill containing all four user fee agreements and a small number of bipartisan, consensus policy provisions. “FDA, industry and other stakeholders have done their jobs by presenting us with proposed user fee agreements,” Senator Enzi said. “Now it's time for us to do our job, and get a bill enacted.”

At the hearing, AdvaMedalso urged lawmakers to move quickly to pass the legislation that would reauthorize the medical device user fee program. David Nexon, AdvaMed senior executive vice president, testified before the committee on behalf of the medical device and diagnostics industry. The association believes the user fee agreement recently reached between the agency and the medical technology industry is a potential game-changer that could help accelerate the development and approval of safe and effective treatments and diagnostics.

“We urge the committee and the Congress as a whole to act promptly to reauthorize the user fee program and enact this agreement into law,” Nexon said.

“Our industry has been a true American success story for patients and for the US economy. America's medical technology industry truly leads the world–but our leadership is slipping. One key reason–perhaps the most important reason–is the significant decline we have seen in FDA efficiency and consistency in recent years,” said Nexon.

The user fee agreement's combination of groundbreaking accountability and transparency measures and enhanced FDA resources has the potential to increase the predictability, consistency, and efficiency of FDA's decision-making, while maintaining the agency's stringent product approval standards. “Put simply, the agreement is good for FDA; it is good for industry; and most of all, it is good for American patients,” said Nexon.

In a press release, AdvaMed said that the device industry appreciates efforts by several Congress members who have introduced legislative proposals to give FDA the tools and structure it needs to succeed. “Legislative reforms that do not alter the substance of the negotiated agreement between FDA and industry and seek to improve consistency and predictability in the FDA device review process hold the potential to create a legislative reauthorization package that maximizes the opportunity for success at the agency, which should be the shared goal of all involved,” said Nexon.

Nexon thanked the members of the HELP Committee for holding today's hearing and stressed industry's commitment “to work with Congress, FDA, and other stakeholders to help make sure the user fee agreement – along with legislative reforms that do not change the terms of the agreement or undermine its goals – wins approval before the current user fee program expires on Sept. 30.” His full testimony can be read here.

Others who testified include

  • Janet Woodcock, M.D. , Director, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD;
  • Jeffrey Shuren, MD, JD , Director, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD;
  • David Wheadon, MD , Senior Vice President of Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America, Washington, DC;
  • Sara Radcliffe , Executive Vice President, Health, Biotechnology Industry Organization, Washington, DC;
  • David R. Gaugh, RPh , Vice President for Regulatory Affairs, Generic Pharmaceutical Association, Washington, DC; and
  • Allan Coukell, BScPharm , Director of Medical Programs, The Pew Charitable Trusts, Washington, DC.

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