Washington — The federal Food and Drug Administration isn’t doing enough to guard against financial conflicts involving researchers who study the safety and effectiveness of new drugs and medical devices, a government audit has concluded.
Only 1 percent of clinical investigators disclosed a financial interest in the products they studied, according to a report on the audit, by the Office of Inspector General of the U.S. Department of Health and Human Services, which reviewed all 118 marketing applications approved by the FDA in the 2007 fiscal year.
“Clinical investigators may not be disclosing all financial interests,” the Office of Inspector General said in a statement accompanying the report.
Outside estimates suggest such lack of disclosure may be widespread. A survey of 3,167 physicians in 2003 and 2004 published by The New England Journal of Medicine found that 28 percent received payments for consulting, giving lectures, or enrolling patients in trials.
“What it essentially says is the FDA pays no attention to watching what it’s supposed to,” Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, a nonprofit advocacy group, said of the audit.
Such conflicts have been alleged previously at American research universities.
The National Institutes of Health halted a five-year, $9.3-million study at Emory University last year over concern that the study’s director, who was later removed, had unreported earnings from drug companies. Congress has been investigating similar concerns about researchers at Harvard and Stanford Universities, and the Universities of Cincinnati and Texas.
The Office of Inspector General issued an audit a year ago that concluded the National Institutes of Health is also not paying attention to hundreds of financial conflicts of interest among university researchers.
The new audit is further evidence of the need for legislation that would require makers of drugs, devices, and biological products to report to the public the money they give to physicians, Sen. Charles E. Grassley of Iowa, the top Republican on the Senate Committee on Finance, said in a statement.
“It looks like the ability of the Food and Drug Administration to track financial ties is just as broken down as that of the National Institutes of Health,” Senator Grassley said.
The Association of American Medical Colleges understands the need for improvements in conflict-of-interest policy governing researchers, said Susan Ehringhaus, the association’s senior director and regulatory counsel. “We’re trying to get our collective arms around this,” Ms. Ehringhaus said. —Paul Basken
