Report faults FDA drug-safety unit

WASHINGTON -- The Food and Drug Administration's office responsible for policing the safety of prescription drugs is underfunded, understaffed, and lacks a ''clear and effective" process for deciding whether and how to act when it determines a drug is unsafe, federal investigators said yesterday. A Government Accountability Office report notes that the FDA's Office of New Drugs, which approves drugs that it determines are safe and effective, spent $110.6 million in 2005 and employed 715 full-time staffers. But the drug safety office spent $26.9 million that year and employed 106 full-time staffers.

The drug safety office has had eight directors in the past 10 years, a turnover rate that the GAO said sapped morale. When the FDA's safety arm made recommendations to the Office of New Drugs -- for which it is a consultant -- often, no action was taken.

While the FDA's drug safety experts cannot make decisions independently, the GAO did not ask for a new, independent drug safety center, as some in Congress have suggested. Instead, the GAO addressed what it viewed as a different FDA weakness: the agency's inability to force drug companies to conduct clinical trials after their products are approved for sale.

The GAO's investigators said Congress needs to consider giving the FDA authority to require that drug makers conduct clinical trials for products once they're on the market and sold to millions of Americans.

Right now, the FDA asks for so-called postmarketing studies but acknowledged that two-thirds of those are incomplete. The FDA should also systematically track postmarket safety problems with drugs, the investigators counseled.

The FDA said the report's conclusions were ''reasonable and consistent with actions we already have underway or planned." But the drug regulator took issue with criticism of its decision-making process as overly complex. Weighing a drug's risks and benefits ''is intrinsically complex," the agency said in its response to the 62-page report.

The government investigators noted that in recent months the FDA made some changes -- such as creating a drug safety oversight board that makes speedier decisions for products on the market -- but said those moves ''will not address all gaps."

The GAO report bolsters the aim of legislation cosponsored by Senator Charles Grassley, the Finance Committee chairman who has leveraged testimony from agency whistle-blowers to question the safety of FDA-approved devices and drugs. In testimony before the Iowa Republican's committee, FDA whistle-blower David Graham said the drug safety office lacked the budget, staffing, and leadership to effectively do its job.

The report said drug safety staffers repeatedly gave the FDA's new drugs arm analyses of problematic drugs sold to consumers, but no immediate action was taken.

Since 2000 the 10 drug withdrawals for safety reasons were done voluntarily by drug companies, not the FDA.

The GAO based its recommendations on a review of agency actions on four drugs approved by the FDA that were later pulled from the market for safety concerns: Arava, an arthritis drug; Baycol, a high cholesterol treatment; Bextra, a painkiller; and Propulsid, a nighttime heartburn remedy.

Grassley said yesterday that the Senate has ample evidence FDA culture needs to change. That legislation need not wait until another report commissioned by the FDA is released this summer, he said. ''The FDA needs to make big changes," Grassley said, adding that the agency tends to ''hunker down in times like this."

Representative Joe Barton said the report shows ''the drug safety system is not in crisis, but the FDA's process may need some fine-tuning." The Texas Republican chairs the House Energy and Commerce Committee, which oversees the pharmaceutical industry, and joined Grassley in requesting the GAO report.

Senator Edward M. Kennedy, Democrat of Massachusetts, said he expects to introduce a comprehensive bill he is cosponsoring this summer to address shortcomings with postmarket drug safety.

The GAO report ''underscores the urgency of our efforts," Kennedy said in a statement. ''Americans expect their medicines to be safe, and we have an obligation to ensure that FDA regulation of drugs -- at approval and after -- remains the gold standard."

Already, some members of Congress are willing to give the FDA more authority -- even though FDA Acting Commissioner Andrew von Eschenbach testified that such sweeping changes were not needed.

''Many in Congress are willing to give this agency the legal authority it needs to increase oversight of drug safety and uphold public health," US Representative Rosa DeLauro, a Connecticut Democrat on a House subcommittee with jurisdiction over the FDA, said. She said she hopes the GAO report will get von Eschenbach to ''reconsider his position."

Diedtra Henderson can be reached at dhenderson@globe.com.