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 Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew 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. Bennett 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.

http://www.nytimes.com/2008/04/16/washington/16fda.html?ref=us