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Senate investigates adequacy of the FDA's proposed '09 budget.

Proposed funding by the White House for the FDA in 2009 doesn't go far enough for the agency to adequately evaluate medical devices, drugs and food, according to a bipartisan panel of lawmakers. During an April 15 Senate Appropriations subcommittee hearing, senators questioned FDA Commissioner Andrew C. von Eschenbach about possible gaps between slated funding and the agency's actual requirements.

The committee currently is reviewing how much taxpayer money will be needed for the FDA in fiscal year 2009, which starts in October. To be adequately funded to protect public health, a panel of external experts assembled by the FDA recently said the agency needs an additional $375 million to improve its oversight activities, and the Senate passed a resolution supporting such an increase. The Bush Administration, through the Office of Management and Budget (OMB)--which is responsible for devising and submitting the president's annual budget proposal to Congress--has put forth a $54 million increase (a little more than 3%) to $1.77 billion. In addition to spending that comes from taxpayer revenue, the agency also has budgeted for $628 million in new user fees in 2009 paid by drug and medical device manufacturers. In his opening remarks, to illustrate the importance of the agency's reach, Sen. Herb Kohl (D-WI), the subcommittee's chairman, noted that 20 cents of every dollar spent by American consumers are for products regulated by the FDA.

"The FDA has a responsibility to ensure that these products are safe and effective," Kohl said, adding that it is a "daunting and growingly complex" task. "However, the FDA's budget request does not keep pace with the agency's huge responsibilities."

Kohl went on to say that while an increase, no matter how small, is preferable to cuts, he found it "hard to believe" that the FDA's budget request as currently planned would "reach anywhere near" the goals the FDA has set for inspections and employee recruitment.

The subcommittee's ranking minority member, Sen. Robert Bennett (R-LIT), agreed with Kohl and, while thanking von Eschenbach for his "stewardship in defense of the agency," attempted to coax the commissioner into saying how much more funding the agency actually could use.

"The FDA's regulatory authority is vast, with $1.5 billion worth of expenditures. We more often hear about problems rather than successes. But there have been problems--the recall of heparin, the recall of tainted food and pet food recalls due to contaminated ingredients from China," Bennett said. "It seems as if the budget is inadequate to meet challenges. It may be our responsibility to fix OMB's mistake here.... It's more than just money. You need the right people--to retain and attract the right people. FDA can no longer fulfill its mission with substantial and sustained appropriations. We all benefit from a strong and well funded FDA. If we move to help you, we want to move to an area that is prudent and not extravagant."

If lawmakers decided 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?" Bennett asked von Eschenbach, acknowledging that the question put the commissioner "on the spot" between defending the administration's proposed budget and perhaps admitting that the funding would not go far enough.

The commissioner said he would "welcome an opportunity to present a scenario of portfolio options" for levels of financing, adding that he did not believe the agency could absorb the recommended $375 million increase in one year.

Von Eschenbach said the FDA has plans to hire up to 700 new employees, but he acknowledged that there would not be enough money to do any hiring next year if Congress adopted the president's budget without any changes.

According to Kohl, the $54 million increase barely covers standard-of-living wage increases for existing staff and would not accommodate additional hires or new spending for medical device, drug or food safety programs--particularly for increased international facility inspections. Kohl specifically cited the FDA's Center for Devices and Radiological Health (CDRH) as experiencing a decrease in staff in the coming year.

"We are on a trajectory to increased staff. We just have to push it off a little," von Eschenbach said, commenting on agency staff overall. For the CDRH, the commissioner sidestepped specifics, but said the FDA would "find ways to leverage current resources and programs and continue to make strategic investments." He also said continued focus by the CDRH and industry on industry post-market surveillance would help.

A report last year by a panel of outside advisers to the FDA said American lives were in danger because the agency did not have the money, the staff or the scientific expertise to protect them. In a recent speech at the National Press Club in Washington, DC, von Eschenbach acknowledged that he was "aware of the need for changes to avoid the peril of failing in our mission to protect your health."

During his Capitol Hill testimony, however, he was a little more optimistic, if tempered, about the agency's impact and effectiveness.

"I believe we have been eminently successful up to this period of time," von Eschenbach said. "We are the world's gold standard. But if we want to continue that level of excellence, we must change."

To meet growing international supply chain pressures, the commissioner said the agency planned to open three new offices this year in the Chinese cities of Beijing, Shanghai and Guangzhou. The combined staff there will total 13 people, five to be hired locally.

"A global supply chain for food an medical products now requires FDA to expand its presence and reach beyond our boarders," von Eschenbach said." There is a complex regulatory pathway from production to consumption."

He added that the FDA plans offices in India, the Middle East, Latin America and Europe.

In related news, the FDA recently sent a letter to medical device manufacturers warning them to review their sources of heparin used in their products, such as heart stents. Some vascular stents and grafts, as well as devices used in pulmonary bypass and in-vitro diagnostic procedures, are coated with heparin.

On March 28, Covidien Ltd. initiated a nationwide recall of its pre-filled lock flush syringes containing heparin as a precautionary measure. Problems with tainted heparin surfaced in the United States in February, raising questions about the safety of the global supply chain for medicine and other products. Baxter International Inc. has recalled heparin products that were found to be contaminated. Baxter officials have said the source of contamination appears to be in China, where ingredients for the problematic heparin originated.

The FDA hasn't determined whether the contaminant was accidentally or deliberately introduced into batches of heparin prepared for export in China.
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Title Annotation:Top of the News
Publication:Medical Product Outsourcing
Date:May 1, 2008
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