Panel’s Bipartisan View: F.D.A. Is Underfinanced ... NY Times April 16, 2008

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NY Times April 16, 2008 Panel’s Bipartisan View:

F.D.A. Is Underfinanced By GARDINER HARRIS WASHINGTON — The Food and

Drug Administration needs far more money than the White House has proposed

for next year, senators of both parties said Tuesday. “To us,

it’s clear that they’re seriously underfunded,†Senator Herb

Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations

subcommittee, headed by Mr. Kohl, that oversees the agency’s spending. The

subcommittee’s ranking minority member, Senator F. ,

Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the

food and drug commissioner, Dr. C. von Eschenbach, to say how much more

the agency could use wisely. If lawmakers decide

that the White House “was wrong and you needed to add another $100

million, just to pull a number completely out of the air, could you handle

that?†Mr. asked. Dr. von Eschenbach

said he would “welcome an opportunity to present a scenario of portfolio

options†for levels of financing. The Senate passed a

budget resolution last month that would make the F.D.A.’s allocated

budget — that part of its spending that comes from taxpayer revenue, as

opposed to user fees paid by drug and medical device manufacturers — $375

million greater in 2009 than this year. That would be a 20 percent increase,

and Dr. von Eschenbach said he did not believe that the agency could absorb so

large an addition in one year. A report last year by

a panel of outside advisers to the agency said American lives were in danger

because the F.D.A. did not have the money, the staff or the scientific

expertise to protect them. And in a speech last month, Dr. von Eschenbach

acknowledged that the F.D.A. “may fail in its mission to protect and

promote the health of every American†and that “peril

exists.†But he was far less

pessimistic in his testimony on Tuesday. “I believe we

have been eminently successful up to this period of time,†Dr. von

Eschenbach said. “We are the world’s gold standard. “But if we want

to continue that level of excellence,†he added, “we must

change.†The Bush

administration has proposed increasing the agency’s allocated budget next

year by 3 percent, to some $1.8 billion, not enough to pay even for increased

costs. Dr. von Eschenbach spoke Tuesday about plans to hire up to 700 new

employees for the F.D.A. staff, but he acknowledged that the agency would not

have the money to do any hiring next year if the president’s budget was

adopted without changes by Congress. “We are on a

trajectory to increased staff,†he said. “We just have to push it

off a little.†Dr. von Eschenbach

said the agency planned to open three new offices this year in the Chinese

cities of Beijing , Shanghai and Guangzhou .

The combined staff there is to total 13 people, 5 of them to be hired locally. Addressing the

controversy over the blood thinner heparin, the commissioner said in his

testimony that contamination in samples whose active ingredient had been

imported from China was “apparently, we suspect, done by virtue of

economic fraud,†to enhance profit. This was the first time anyone at the

F.D.A. had confirmed that the agency suspected that the drug’s

contamination had been deliberate. But after the hearing,

Dr. von Eschenbach said that he “probably went too far†in his

testimony and that the agency did not have proof that the contamination had

occurred as a result of fraud.

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