Washington Editor

WASHINGTON - Former FDA Commissioner Donald Kennedy suggested to lawmakers on Tuesday that an orphan drug-type provision could spur drugmakers to develop new antibiotics to replace those associated with growing resistance problems.

"There's dramatic growth even since 1985 in the proportion of hospitals that are reporting unmanaged infections," he told members of the House Oversight and Government Reform Committee during a hearing on improving the FDA. "There ought to be some special intellectual property reward for somebody who goes after an antibiotic that can replace one to which there's resistance."

Seconding that suggestion, another former FDA commissioner, Frank Young, cited the decrease in private equity and venture backing in antibiotics as evidence that Congress should intervene to create a market incentive.

Much of the rest of the inquiry focused on some familiar proposals to better the FDA, many of which recall last fall's drug safety recommendations from the Institute of Medicine. The hearing took place in the backdrop of the Senate's ongoing debate on the "Food and Drug Administration Revitalization Act," a wide-reaching piece of legislation that would renew the Prescription Drug User Fee Act (PDUFA) and authorize new safety powers at the agency, among other things. A vote could come today.

Kennedy, who noted that the agency "has for some time been chronically underfunded and understaffed," said that the FDA needs a 5.8 percent budget increase every year just to "conserve its purchasing power from one year to next." Instead, he pointed out that the agency's current budget is about 20 percent less than what it should be relative to 2003, with a disproportionate reduction in the number of employees.

Also related to funding, Young cautioned against the growing imbalance between drug review and safety monitoring activities created by the user fee program, and said Congress should shift the FDA's appropriations authority from agriculture committees to health and labor oversight committees. "We've now moved to a different era," he said, adding that lawmakers should seek to reduce the numerous overlapping panels that oversee the agency.

Kennedy and others also said the FDA needs to improve its post-approval drug safety monitoring system and suggested that congressional support for health care information technology could help support public disclosure of full, robust data and other information from clinical trials.

In addition, he spoke out against recent leadership turnover at the FDA, as did Young, who said it "has been scandalous." He suggested that Congress examine the commissioner recruitment process and perhaps return to a system that doesn't require confirmation proceedings. Young also called for a six-year appointment for commissioners.

Suggesting that Congress should look at the "strength of the scientific base" at the FDA, he said the agency's staff members should have continued professional training and the freedom to pursue their own studies. Also, he criticized funding cuts that have "eviscerated" research within the Center for Biologics Evaluation and Review and left "very little" of it inside the CDER.

Young implored Congress to "bring a screeching halt to unfunded mandates," warning that efforts to craft new laws, such as proposals to devise an approval pathway for follow-on biologics, should account for staffing needs to implement and enforce the new rules. He and others also said the FDA's inspection personnel and regional laboratories require a boost to keep up with growing consumer protection demands with regard to both drug and food safety. In fact, much of the hearing centered on the latter, what with recent high-profile outbreaks involving tainted spinach, peanut butter and pet food.

Another former FDA commissioner, David Kessler, called for a food commissioner to oversee such matters. "FDA can react to outbreaks," he said, "but the emphasis needs to be on preventing outbreaks before they happen."

Current FDA Commissioner Andrew von Eschenbach, who testified last, said that newly created leadership positions are putting in place a management infrastructure to carry the agency forward to deal with its myriad challenges, as are new facilities. In addition, he noted that FDA guidances and rules can be powerful tools as opposed to new but unfunded legal mandates.

Committee Chairman Henry Waxman (D-Calif.), said that "a number of public health crises" have "revealed alarming cracks" in the FDA's ability to function optimally. He also noted that the hearing marked the first of several he plans to hold to focus on the effectiveness of various government agencies. "Incompetent government can have deadly consequences," he said, noting that he would work to "ensure that [the FDA] has the resources" needed to perform its duties.

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