F.D.A. proposes 23% budget increase for 2011

by Jay Sjerven
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WASHINGTON — The Food and Drug Administration requested funding for fiscal 2011 at $4,031,658,000, a level 23% higher than the $3,284,066,000 approved by Congress for the agency in the current fiscal year. The budget request compared with enacted funding of $2,793,812,000 in fiscal year 2009. The requested increase from fiscal 2010 included a $146 million increase in budget authority (funds appropriated by Congress) and a $601 million increase in industry user fees.

“The fiscal year 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, manytimes each day,” said F.D.A. Commissioner Margaret A. Hamburg, M.D.

The proposed budget would support the F.D.A.’s new authority to regulate cigarettes and other tobacco products, but food safety would receive the lion’s share of the requested increase in funding from fiscal 2010. Increases also were requested for the agency’s regulatory responsibilities relating to drugs and medical devices.

The importance accorded the F.D.A., and its regulatory responsibilities for food safety stood out in the president’s budget, which called for a freeze or even cuts in many other agencies and discretionary spending programs.

The F.D.A. requested program level funding for its food and feed safety activities at $1.4 billion, up $318 million, or 30%, from fiscal 2010 appropriations at $1.1 billion. Of the $318 million increase requested for fiscal 2011, congressional appropriations would account for $80 million and new user fees would account for $238 million.

The agency’s budget authority for its food and feed safety activities would be increased 8% from fiscal 2010, to $1.1 million, under the president’s budget proposal. Because the user fees proposed would be new, there were no comparisons with 2010 or earlier years.

The F.D.A. said of the food and feed safety portion of its budget proposal, “The F.D.A. will set standards for safety, expand laboratory capacity, pilot track-and-trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.”

The Center for Food Safety and Applied Nutrition would receive $259 million under the budget proposal, up 10% from $237 million in fiscal 2010 and compared with $210 million in 2009. Food safety-related field activities would receive $587 million, up 7% from $548 million in fiscal 2010 and compared with $434 million in fiscal 2009.

The budget’s food safety proposal assumed approval of three new user fees, including $14 million in re-inspection fees, $4.4 million in export certification fees and $220 million in food registration and inspection user fees.

There was broad support for increasing congressional appropriations for the F.D.A., including among food manufacturers, but the proposed new user fees faced resistance.

Peter Barton Hutt, senior counsel at the Washington law firm of Covington & Burling and former chief counsel for the F.D.A., was delighted the president’s budget asked for a $146 million increase in appropriations for fiscal 2011.

“That’s darn good in an economy when nearly all other agencies are getting cut,” Mr. Hutt said. While Mr. Hutt favored even larger appropriations for the F.D.A., he said after a couple of years of increased funding for the F.D.A., “we’re on track to getting where we have to be.”

Mr. Hutt pointed out for the past several years, the F.D.A. has proposed various new user fees, and each year the fees were rejected in final appropriations legislation. He said there was no reason to expect a different outcome this year. But in previous years, when fees proposals were pulled out of the legislation, the money requests involved often simply disappeared. This year, that may not be the case.

The House of Representatives in August passed the Food Safety Enhancement Act, which included user fees. The F.D.A. based its proposed user fees in part on those proposed in the bill. The Senate bill, the Food Safety Modernization Act, was yet to be debated on the Senate floor but included no new user fees with bill sponsors stating taxpayers should pay the costs for increased F.D.A. capabilities because the benefits would be shared by all. The Senate version was the one favored by industry.

“The House and Senate have not gotten together yet,” Mr. Hutt said. “They’re still licking their wounds after the health care debate. The real question is, once the streets of Washington are cleared of snow, will Congress turn back to the health care debate or put it to one side so they can try to deal with things they can actually do.”

Representative Rosa DeLauro of Connecticut, chairwoman of the House Appropriation Committee’s subcommittee on agriculture, rural development, F.D.A., said she was pleased the president was seeking to increase the F.D.A.’s budget but expressed concern that the U.S. Department of Agriculture’s Food Safety and Inspection Service “remains essentially frozen with a miniscule 1.9% increase.”

The U.S.D.A. proposed an F.S.I.S. budget for fiscal 2011 at $1,046 million, up $18 million, or 2%, from an estimated $1,028 million in fiscal 2010 and compared with an enacted $983 million in 2009.

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