THE WALL STREET JOURNAL

Specter Says Bush Administration Is Hindering Quick FDA Funding
By JARED A. FAVOLE <jared.favole@dowjones.com>
June 11, 2008 11:54 a.m.

WASHINGTON -- Sen. Arlen Specter said the Bush administration is "drastically hindering" the Food and Drug Administration's ability to quickly get an important boost in funding.

In a letter sent Tuesday to Health and Human Services Secretary Michael Leavitt, Sen. Specter said the FDA's request on Monday for an additional $275 million wouldn't give them any money until March or April 2009 "at the earliest."

In a handwritten note on the letter, the Pennsylvania Republican said the "Administration is drastically hindering necessary immediate relief by delaying the funding for eight or nine months." He added, "FDA needs this money now to save lives."

A spokeswoman for Sen. Specter confirmed that he is referring to the Bush administration in the hand-written portion of the letter.

Sen. Specter has been working to get the agency $275 million in the fiscal 2008 supplemental appropriations bill. He said the FDA's request "undermines" the Senate's efforts to get the agency funds on an "expedited basis."

Sen. Specter acknowledged Congress is considering eliminating the FDA funding from the supplemental appropriations bill. If the bill was signed with the FDA funding intact, the FDA would have to receive the money by Sept. 30, the end of the fiscal year.

On Monday, while under pressure from recent recalls of imported drugs and other products, the FDA formally requested $275 million from Congress to pay for more inspections.

In mid-May FDA Commissioner Andrew von Eschenbach wrote a letter to Sen. Specter suggesting an additional $275 million in the wake of a series of hearings on Capitol Hill over the FDA's handling of the crisis involving contaminated heparin, a blood thinner, from China. Mr. von Eschenbach's letter wasn't a formal request and only represented his professional judgment.

Sen. Specter said in Tuesday's letter that the FDA's recent request shows a lack of urgency on the agency's behalf.

"The 81 deaths due to contaminated heparin and the one suspected death in the ongoing salmonella outbreak show that we cannot wait nine months to give FDA the resources needed to protect the public," Sen. pecter said, according to a copy of the letter.

Contaminated heparin from China has been linked to 81 deaths. Last week, the FDA said it found an additional 11 deaths tied to medical devices that contained heparin. The agency is still trying to determine whether the heparin in those cases was contaminated.