Bush Seeks $275 Million for U.S. Food, Drug Safety

JUNE 11TH, 2008 | Harkin for Senate

By JUSTIN BLUM, Bloomberg

June 10 (Bloomberg)—The Bush administration increased its budget request for the U.S. Food and Drug Administration by $275 million after the agency’s commissioner told Congress that more funding was needed to protect against unsafe products.

The money would augment $2.4 billion previously sought by President George W. Bush for the fiscal year starting Oct. 1, said U.S. Health and Human Services Secretary Michael Leavitt in a conference call with reporters yesterday. More resources are needed to police food, drugs and medical devices, Leavitt said.

Lawmakers have criticized the FDA’s performance after the blood thinner heparin was found to have a contaminated ingredient from China. The FDA commissioner, Andrew von Eschenbach, wrote a letter last month to Senator Arlen Specter, Republican of Pennsylvania, saying the agency needed $275 million to beef up inspections of manufacturers.

The products regulated by the FDA “are essential and critical to the welfare of every single American,’’ said Von Eschenbach during the same conference call.

The extra funding will allow the FDA to conduct at least 1,000 additional overseas inspections of plants producing food and medical products imported into the U.S., and 1,000 more domestic plant reviews than are carried out now, according to a statement from Leavitt’s department.

Money also will be used to station FDA employees in China and elsewhere, and to improve the agency’s computer tracking systems.

“This increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace,’’ Leavitt said in a statement.

`Long Overdue’

Senator Tom Harkin, an Iowa Democrat, said the spending proposal was “long overdue.’‘

“Congress has asked FDA repeatedly if additional funding was needed to carry out its mission and ensure the safety of our food and drug supply,’’ Harkin said in an e-mailed statement. “Finally, FDA presents a more accurate budget picture so that Congress knows what needs to be done.’‘

The value of imported medicine and drug compounds reached $48.9 billion last year, up more than 30-fold from $1.57 billion in 1990, according to the Census Bureau.

In February, Bush proposed increasing the FDA’s budget for next year by 5.7 percent to $2.4 billion. Congress must approve the FDA budget.

Representative John D. Dingell a Democrat from Michigan who is chairman of the House Energy and Commerce Committee, said at a hearing in April that von Eschenbach wasn’t doing his job and hadn’t asked for enough money to inspect overseas drugmakers.


Dingell pointed his finger at von Eschenbach and repeatedly asked the FDA chief how much it would cost to do more inspections. Dingell objected when the commissioner didn’t provide specifics.

Last month, Senator Specter wrote von Eschenbach asking how much additional funding the agency needed. The commissioner replied in a letter, saying that $275 million was needed based on “my professional judgment.’‘

The funds requested yesterday include $125 million to protect the food supply, $100 million for the safety of drugs and medical devices and $50 million to prepare the FDA’s workforce and laboratories for “areas of emerging science’’ such as nanotechnology and gene therapies, according to the statement.

To contact the reporter on this story: Justin Blum in Washington at [email protected].

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