Legislation that would exempt FDA user fees from cuts under sequestration was introduced this week in the House. Medical Design joins AdvaMed in praising Reps. Leonard Lance (R-NJ), Anna Eshoo (D-CA), Doris Matsui (D-CA), Mike Rogers (R-MI) and the other co-sponsors of this legislation, which will let FDA to have full access to the user fees paid by medical technology companies and other FDA-regulated industries.
“Since the sequester took effect March 1, medical device and diagnostics companies have been paying the full amount of user fees to FDA as negotiated under last year’s FDA Safety and Innovation Act (FDASIA)," said AdvaMed President and CE Stephen J Ubl. "However, because of sequestration, in FY 2013 alone $2.9 million in medical device user fees will not be available to the agency. Going forward into next year and beyond, additional medical device user fees are at risk because of sequestration."
Kudos to AdvaMed and the above-mentioned legislators and cosponsors for successfully communicating to lawmakers the differences between user fees and appropriated funding.
"The fees negotiated under FDASIA (Food and Drug Administration Safety Innovation Act) represent an agreement between industry, FDA and Congress," says Ubl. "Under that agreement, industry agrees to supplement FDA’s appropriated budget with user fees, and the agency agrees to performance commitments designed to increase the efficiency and predictability of the review process. User fees are not taxpayer dollars.
“By exempting FDA user fees from the sequester, this legislation will restore the agreement negotiated by industry, the agency, and the Congress and ensure that FDA will be able to use all the funds paid by industry for the improvement of the review process. That is in the best interest of FDA, the industry and the millions of American patients who will benefit from more timely access to innovative medical technologies."