Senate joins effort to save FDA user fees from sequester

Sen. Mark Pryor (D-AR)

Echoing their counterparts in the House, 5 senators from both parties have introduced a bill that would spare millions of FDA dollars from mandatory budget cuts, allowing the agency to use industry-provided money to speed up approvals.

The bill, introduced by Sen. Mark Pryor (D-AR), is nearly identical to the House version introduced by Rep. Anna Eshoo (D-CA) two weeks ago. Titled the FDA User Fee Protection Act, the Senate bill would alter the 1985 legislation that sets the rules for sequestration, adding a provision to shield what the agency gathers directly from industry.

The agency plans to collect roughly $1 billion in user fees in fiscal 2013, including about $100 million from medical device outfits. However, thanks to sequestration, the FDA can't touch about $85 million of that, making it nearly impossible for the agency to keep the promises it made last summer when Congress approved a hike in what device and drug companies pay for approvals.

Industry groups like AdvaMed, BIO and PhRMA have come out in support of the now bicameral effort, and AdvaMed CEO Stephen Ubl said fixing the issue is a win-win for the FDA, Congress and the industry.

"User fees paid by industry to FDA should not be treated the same way as taxpayer dollars," Ubl said in a statement. "By exempting FDA user fees from the sequester, (the bill) 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."

Sens. Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) joined Pryor in sponsoring the bill. The House version, called the FDA Safety Over Sequestration Act, was introduced July 19 by Reps Leonard Lance (R-NJ), Anna Eshoo (D-CA) Doris Matsui (D-CA) and Mike Rogers (R-MI).

- read the bill (PDF)
- check out AdvaMed's statement

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