Following criticism in recent months that the Food and Drug Administrations oversight of foreign production of medical products and food is lacking, the Bush administration is looking to boost the agencys funding.
The Bush administration will ask Congress for an additional $275 million in fiscal 2009 for more workers, programs and technology and the authority to outsource regulatory work at the FDA.
The FDA came under fire earlier this year after doses of heparin produced in China were found to have been tainted. And the move comes as healthcare providers ramp up their use of drugs and devices produced overseas (May 26, p. 28).
The new appropriation request, to be added to the fiscal 2009 budget the White House submitted to Congress in February, was revealed last week at a news conference by HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach.
Combined with an increase in the original FDA request in the February budget, Leavitt called for $404.7 million in higher spending at the FDA in 2009 than in fiscal 2008, a 17.8% boost that will include money for 490 new FDA jobs.
Leavitt said the extra money would be used to establish additional foreign offices, possibly in Central America, China and India; increase technical assistance on food standards to countries that export to the U.S.; conduct more risk-based inspections of foreign food and medical product facilities; develop a system to trace products from consumption back to the source of production; and upgrade FDA information technology to facilitate networking between the agency and federal, state and local testing laboratories.
Leavitt said the funding proposal also includes multiple requests for Congress to expand FDA authority. One would allow the FDA to outsource its work by accrediting independent, third parties for voluntary inspections. Another would authorize the FDA to bar imports if a company delays, limits or denies access to agency inspectors. A third would empower the FDA to require certification of designated, high-risk products as an additional condition of importation.
The trade group Pharmaceutical Research and Manufacturers of America applauded the request. Senior Vice President Ken Johnson in a written statement praised the application of $100 million of the new money toward the agencys budget for safety activities for medical products and drugs. But Johnson said, The challenges of globalization and the risks posed by rare adverse events are sobering, and the FDA requires more than a one-time infusion of additional dollars.