Washington Editor

WASHINGTON - More than a week after the Institute of Medicine issued its wide-ranging criticism of the FDA's drug safety oversight abilities, which noted "an imbalance in the regulatory attention and resources available before and after approval," reactions to the report's recommendations have come from multiple angles.

"Work still needs to be done," Acting FDA Commissioner Andrew von Eschenbach conceded in a conference call, though he added that "considerable" efforts have been ongoing over the past two years to improve the situation. For example, he pointed to a growing number of partnerships related to the Critical Path Initiative to modernize the FDA's mission, the creation of its Drug Safety Oversight Board, improved package inserts, web-based labels and improved risk communication strategies, among other things.

Still, von Eschenbach said the agency would consider the IOM's recommendations and said he was "committed to taking additional steps."

The IOM report highlights the agency's "chronic underfunding." There is broad support for increasing the FDA's budget, both among drug industry advocates as well as those in favor of stronger consumer protections. Members of those opposing camps have made announcements through two coalitions formed to remedy it, the FDA Alliance and the Coalition for a Stronger FDA.

Among members of the former is Tommy Thompson, the former secretary of the Department of Health and Human Services. He called the FDA "the poor stepsister" to the National Institutes of Health and the Centers for Disease Control and Prevention, two other federal health care agencies with far larger budgets.

"The problem is simple," said Jim Greenwood, the president and CEO of the Biotechnology Industry Organization (BIO), which also is part of the Coalition for a Stronger FDA. "The FDA has been given more responsibilities than it has resources."

It's less likely that drug industry advocates would favor other recommendations put forth in the IOM report, though.

For example, one of its reform proposals calls for Congress to include safety-related performance goals in the next version of the Prescription Drug User Fee Act, for which negotiations already are well under way. The industry has been seeking to ensure that user fees are directed toward product reviews, their original intent, instead of getting directed to other FDA responsibilities.

Of note, though, the IOM committee came down in favor of taxpayer-generated appropriations from Congress instead of user fees, in general.

Other recommendations include special symbols on newly approved product labels for the first two years they're on the market, advertising limits during the same period and post-approval reviews five years after products are launched to evaluate all accumulated benefit and risk information. In addition, the report indicated the IOM's preference for providing the FDA power to ensure that drug companies comply with label changes and conditions imposed on new products upon or after approval, along with enforcement tools such as fines, injunctions and withdrawals.

In terms of proposals for organizational changes, the IOM report suggested that the FDA should give its Office of Surveillance and Epidemiology (formerly the Office of Drug Safety) joint authority with the Office of New Drugs for conducting post-approval regulatory activities, and Surveillance and Epidemiology staffers should be included on new drug application review teams. In addition, the report recommended that FDA commissioners should be appointed for a six-year term.

The IOM also recommended that at least 60 percent of advisory committee members be free of financial ties to companies that could be affected by their deliberations.

The FDA requested the report early last year as part of its internal efforts to reform its oversight of drug safety.

NIH Update Passes In House

The House of Representatives last week passed a bill that would reauthorize the research agency for the first time in 13 years, just ahead of this month's mid-term election recess.

Called the "National Institutes of Health Reform Act of 2006," the measure would authorize a 5 percent annual increase in its budget for the next three government fiscal years. Over the past few years, the NIH budget has remained relatively flat, at about $28 billion. Also along funding lines, the bill would establish a common fund to support research that cuts across multiple institutes or centers. The common fund would be capped at 5 percent of the overall NIH budget.

In addition, the bill includes several provisions to streamline operations. It would provide for an agency-wide electronic reporting system to catalog all research activities in a standard format, and would limit the number of national research institutes and national centers to 27, the NIH's present size. It also includes a mechanism for organizational shakeups, creating a management review group to evaluate NIH's structure at least once every seven years and propose any restructuring plans it deems necessary.

The bill, labeled H.R. 6164, is principally sponsored by Rep. Joe Barton (R-Texas), the chairman of the House Energy and Commerce Committee. No immediate action is expected in the Senate.

House Also Clears BARDA

Last week, the House passed a bill to boost the lagging biodefense space by creating a new government agency to fund mid-stage product development for antidotes and vaccines against biological weapons and infectious diseases.

There has been little progress in luring the drug industry to the $5.6 billion promised by Project BioShield because of the funding gap that has left investors and companies uncertain of market success. But the "Biodefense and Pandemic Vaccine and Drug Development Act of 2006" would establish the Biomedical Advanced Research and Development Authority (BARDA) as a single point of federal authority to fund that gap. The bill provides for $160 million in each of the next two government fiscal years to do so.

The money isn't coming yet, though, because a Senate bill that includes provisions related to BARDA has yet to reach the floor. The House bill, H.R. 5533, is sponsored by Reps. Mike Rogers (R-Mich.) and Anna Eshoo (D-Calif.).

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