Sen. Mark Pryor (D-Ark.) has introduced a bi-partisan bill to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration.
In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress. Included in those cuts were the user fees medical device and pharmaceutical companies pay in order to ensure timely reviews of new devices and drugs.
The bill, titled " A bill to exempt from sequestration certain fees of the Food and Drug Administration" currently has 4 co-sponsors including Sen’s Roy Blunt (R-Mo.), Dan Coats (R-IN), Al Franken (D-Minn.) and Jerry Moran (R-Kan.). The bill has been referred to the Commitee on Budget, however, the Upper Chamber is slated to adjourn for its August recess this week and will not resume work until September.
The Senate move follows a similar bill forwarded in the House of Representatives 2 weeks ago. That bill, dubbed the “FDA Safety over Sequestration (SOS) Act,” was introduced by Reps. Leonard Lance (R-N.J.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.).
AdvaMed, the chief lobbying group for the medical device industry, praised the Senators for taking action.
"User fees paid by industry to FDA should not be treated the same way as taxpayer dollars,"AdvaMed president and CEO Stephen Ubl said in prepared remarks. "The fees paid by medical technology companies under FDASIA represent an agreement between industry, FDA and Congress. 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."
He added that by "exempting FDA user fees from the sequester, S.1413 restores the agreement negotiated by all three parties and ensures FDA will be able to use all the funds paid by industry to improve its review process. That is a win-win-win for FDA, the industry and the millions of American patients who will benefit from more timely access to innovative medical technologies."
In March, FDA commissioner Dr. Margaret Hamburg said she was concerned that the federal budget freeze had left the agency "stranded in fiscal 2012" and would harm the tenuous accord forged between the FDA and the medical device industry.
In June 2012, Congress passed the MDUFMA reauthorization, which doubled medical device user fees from $295 million over 5 years to $595 million. That deal came after several months of tense negotiations with the medtech industry.