House Holds Hearing on User Fee Proposals
The House Energy and Commerce Subcommittee on Health held a hearing today entitled "FDA User Fees 2012: How Innovation Helps Patients and Jobs," to examine all of the proposed user fee negotiations, including MDUFA.
While the hearing examined the various components impacting the industries that pay user fees, special attention was paid to language in the draft proposal that would expand FDA's mission beyond protecting public health and enabling patients' access to novel products. Under the proposal, the FDA's new mission would also include "promoting economic growth, innovation, competitiveness and job creation."
"As MDUFA reauthorization continues to progress through Congress, MDMA appreciates all of the House Subcommittee's work to highlight the concerns of medical device innovators," said Mark Leahey, President and CEO of MDMA. "The medical device community continues to stand ready to deliver on the promises of better patient care and more job creation, and restoring predictability and transparency to the premarket review process will help empower them to do so."
Both the Senate and House versions of user fee legislation are expected to be voted on next week in their respective committees.