Posted 06 June 2013
By Alexander Gaffney, RF News Editor
US healthcare product regulators stand to get a sizable boost in their funding during the next fiscal year if the House Appropriations Committee gets its way.
The Committee's Agriculture Appropriations Subcommittee, which has budget authority over the US Food and Drug Administration, met on 5 June 2013 to mark-up the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, which would set FDA's funding for the 2014 fiscal year.
During this past year, budget sequestration procedures reduced FDA's budget considerably, taking more than $200 million in appropriated funding and around $80 million in collected user fees-a considerable sum for an agency with a relatively small appropriated budget of $2.46 billion.
But as reported by the Alliance for a Stronger FDA, a budget watchdog that advocates for additional funding for FDA, the agency is poised to face more favorable budget conditions in the coming year.
Under the bill, FDA would be given $2.485 billion in budget authority with which to carry out its statutory activities. The funding would put FDA $96 million ahead of where it was immediately after the sequester, when it only had $2.335 billion in budget authority.
Notably, the budget authority funding number does not include user fees, which are paid for by the pharmaceutical, medical device, biotechnology, food and tobacco industries. Those fees nearly double FDA's total funding.
The increase would go primarily toward FDA's food programs ($56 million increase), with other substantial increases for human drugs ($27 million), biologics ($12 million) medical devices ($17 million), toxicology research ($3 million), the Office of the Commissioner ($14 million) and FDA's facilities ($14 million). Some money would be taken away, however, including $5 million in building and facilities repair authority and $49 million in one-time supplemental food and drug safety funding.
Still, despite the increase, FDA's funding would still be below both historical and sought-after levels. In Fiscal Year 2012, for example, FDA was appropriated $2.507 billion in funding, $22 million more than it stands to receive under the current proposal. The allocated funding would also be well below the $2.558 billion President Barack Obama has called for in his 2014 budget proposal.
Still, advocates of FDA said the change was a "positive step in the right direction."
"In this time of continuing deficit reduction, we understand the difficult fiscal environment under which the House is operating." said Diane Dorman, president of the Alliance and vice president for Policy at the National Organization for Rare Disorders (NORD). "We believe that FDA's funding needs to be increased further-well above the FY 12 level--to reflect the agency's vast public health responsibilities and continually increasing workload. If the FDA does not have the resources to fulfill its mission, there is no other federal, state or private agency that provides a fallback. "
ASFDA Budget Analysis