House Committee Passes User Fees Proposals, Full Chamber Consideration Next
Thursday, May 10, 2012
The House Energy and Commerce Committee held a full committee markup
this week of H.R. 5651, "The Food and Drug Administration Reform Act of
2012," which consists of all the user fee proposals.
Mark Leahey, President and CEO of MDMA, thanked the leaders of the
Committee for having an open and transparent process to improve the user
fee programs, noting that patient care is improved when medical device
innovators develop new technologies under the assurance of a fair,
predictable and transparent FDA.
"While we recognize that the ultimate success of this program will
depend on whether the goals outlined in the Commitment Letter will be
realized in the coming years, we are encouraged by several provisions
which should restore predictability and transparency to the regulatory
process," said Leahey. "These include a more reasonable IDE process,
strengthening the least burdensome doctrine, reporting of total time for
review and others."
MDMA continues to work with both the House and the Senate for timely passage of the reauthorization package.