FDA proposes fiscal 2014 user fee rates

FDA proposes fiscal 2014 user fee rates

The FDA wants to raise the user fees paid by medical device companies for the watchdog agency’s review by 4.2% across the board.

The FDA’s Center for Devices & Radiological Health said today that it proposes to boost the fees for both small businesses making less that $100 million annually and for their larger brethren.

The increases would cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA.

The fiscal 2014 rates would see PMA applications cost $$258,520 for large companies (up from $248,000), with small-business PMAs running $64,630 (up from $62,000). Applications for 510(k) clearances would cost $5,170 (up from $4,960) for large firms and $2,585 (up from $2,480) for small businesses. Set to go into effect October 1, the new fees would generate an estimated $115 million for the FDA, according to the Federal Register.

But it’s still unclear whether the agency will get to spend any of that cash now that sequestration is the law of the land. The FDA lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, due to the pact between the White House and Congress that’s designed to shave 5% off of federal budgets across the board.

Moves are afoot in Congress to exempt the user fees from sequestration. Sen. Mark Pryor (D-Ark.) introduced a bipartisan bill last month, "A bill to exempt from sequestration certain fees of the Food and Drug Administration," to that effect, winning 4 co-sponsors including Sens. Roy Blunt (R-Mo.), Dan Coats (R-Ind.), Al Franken (D-Minn.) and Jerry Moran (R-Kan.). The measure was referred to the Senate Budget Committee, which is unlikely to take it up before the August recess this week.

The Senate move follows a similar bid in the House of Representatives 2 weeks ago. That bill, the "FDA Safety over Sequestration (SOS) Act," introduced by Reps. Leonard Lance (R-N.J.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.). There were 30 co-sponsors of the House bill as of yesterday.

Here’s a comparison of the new user fee schedule for fiscal 2014 with the user fee rates for this fiscal year:

Application type Fee for FY2013 Fee for FY2014 (proposed) Percentage increase Small business fee FY2013 Small business fee FY2014 Percentage increase
510(k) $4,960 $5,170 4.2% $2,480 $2,585 4.2%
513(g) $3,348 $3,490 4.2% $1,674 $1,745 4.2%
PMA, PDP, PMR, BLA $248,000 $258,520 4.2% $62,000 $64,630 4.2%
panel-track supplement $186,000 $193,890 4.2% $46,500 $48,473 4.2%
180-day supplement $37,200 $38,778 4.2% $9,300 $9,695 4.2%
Real-time supplement $17,360 $18,096 4.2% $4,340 $4,524 4.2%
BLA efficacy supplement $248,000 $258,520 4.2% $62,000 $64,630 4.2%
Annual report $8,680 $9,048 4.2% $2,170 $2,262 4.2%
30-day notice $3,968 $4,136 4.2% $1,984 $2,068 4.2%

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