Probe of FDA gets more support from key lawmakers

GAO will undertake the monstrous task of taking inventory of FDA's staff and resource needs at the behest of key Senate and House chairmen, becoming the second outside group lawmakers have solicited to give them a look at the agency's deficiencies.

GAO's healthcare director Marcia Crosse said Monday details are murky, but her unit will assess FDA's needs. "We do expect to be doing the work, but the details and the timing have not been worked out," Crosse said.

The scope of the investigation is being discussed between GAO and staff for Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy, D-Mass., and House Oversight and Government Reform Committee Chairman Henry Waxman, D-Calif., -- who originally requested the study last month -- and House Energy and Commerce Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich.

Dingell and Stupak signed on to the request more than a week ago. They have grown increasingly frustrated with what they say is FDA officials' inability to level with them on funding.

The review will involve an intense effort by GAO, Crosse said. "We anticipate that it will involve multiple teams in GAO doing work," she said.

Typically, GAO analyzes certain aspects of FDA, most recently the agency's foreign medical device manufacturer inspections and the food protection plan FDA released in November. Crosse declined to estimate how long the work will take.

Kennedy and Waxman have homed in on FDA's food-safety budget, which some say isn't enough to fund monitoring the increasing number of imports.

The president requested $662 million for food protection efforts at FDA in fiscal 2009, a $42 million increase that falls far short of what many advocates, lawmakers and stakeholders wanted, given a string of high-profile fiascos involving contaminated food in the last year.

Waxman, Dingell, Stupak and Energy and Commerce Health Subcommittee Chairman Frank Pallone, D-N.J., also asked FDA's own science advisory board subcommittee on science and technology to assess the agency's needs.

Gail Cassell, chairwoman of the subcommittee and vice president of scientific affairs at Eli Lilly, accepted the task, but she could not be reached Monday to determine if the subcommittee has met on the matter.

Cassell's panel released a report in December that said FDA fails to ensure the safety of any of the products it oversees, mainly because of underfunding.

FDA directed the group not to look into resources, but rather to assess only the agency's ability to perform its duties. The group determined the two could not be separated, but it did not make dollar-figure recommendations.