Senate Committee Holds Hearing on MDUFA Reauthorization
Wednesday, March 28, 2012
The Senate Health, Education, Labor, and Pensions (HELP) Committee
held a hearing this week to discuss the proposed agreement on user fees
and other enhancements to FDA's regulatory processes.
The hearing, entitled "FDA User Fee Agreements: Strengthening FDA and
the Medical Products Industry for the Benefit of Patients," provided
testimony from CDRH Director Jeff Shuren and other public officials and
"MDMA thanks the Senate HELP Committee for all of its work to ensure
patients and providers have timely access to medical technology
innovations," said Mark Leahey, President and CEO of MDMA. "All
stakeholders need to continue working towards restoring predictability
and transparency with the premarket review process so that tomorrow's
innovations are available in the United States first."
To view a recording of the hearing, click here.
The hearing follows similar ones held by the House of Representatives
in recent weeks on the various user fee agreements. Both chambers are
expected to bring the proposals for a vote in the coming months, with
any differences to be worked out in what is known as a Conference
MDMA is working with FDA officials and Members of Congress as this legislation continues to move forward.