IOM panel begins review of Rx drug safety

July 11, 2005

An Institute of Medicine panel began a year-long investigation last month with hope of recommending fixes to the nation's foundering drug safety system. The panel was commissioned by Food & Drug Administration officials, who pledged to seek improvements to safety monitoring in the wake of highly publicized problems with COX-2 drugs, selective serotonin reupake inhibitor (SSR) antidepressants, and other products.

An Institute of Medicine panel began a year-long investigation last month with hope of recommending fixes to the nation's foundering drug safety system. The panel was commissioned by Food & Drug Administration officials, who pledged to seek improvements to safety monitoring in the wake of highly publicized problems with COX-2 drugs, selective serotonin reupake inhibitor (SSR) antidepressants, and other products.

Still, the pace of reforms remained an open question, as other FDA safety efforts fell under criticism by lawmakers who are pledging to pass new laws to shake up the agency.

FDA officials made their most unequivocal statement yet, acknowledging serious shortcomings in how drugs are tracked for safety throughout the U.S. healthcare system and whether the agency adequately communicates about safety concerns. "This system has obviously broken down to some extent as far as the fully informed provider and fully informed patient," said Janet Wood cock, FDA's deputy commissioner of operations.

But officials also urged IOM experts meeting for the first time in early June not to focus solely on FDA. In stead, the agency said it wants a broad review of drug safety throughout the U.S. health system, including premarket drug reviews, the effectiveness of physicians' practice guidelines, and the potential of safety-enhancing electronic prescribing. "I don't think you're going to be successful in making recommendations on how to improve drug safety by focusing only on the FDA," said Steven Galson, M.D., acting director of FDA's Center for Drug Evaluation & Research.

That view was backed by drug companies, who have voiced opposition to any changes in FDA's structure or increases in its legal clout. "The FDA's current legal authorities over drug safety are robust and need not be altered," said Alan Goldhammer, associate VP for regulatory affairs at the Pharmaceutical Research & Manufacturers of America (PhRMA).

Others urged the panel to move quickly in making recommendations that could be followed up by reformers in Congress. Bill Vaughan, senior policy analyst for Consumers Union, urged experts to issue an interim report in the next few months that would encourage lawmakers to grant FDA the authority for ordering safety trials and the ability to "require-not beg-changes in safety labels."

"We urge you to inject a sense of urgency into this process," Vaughan said. Panel co-chair Sheila Burke, who is also COO of the Smithsonian Institution, said, however, that the panel has no plans to issue interim findings.

Perhaps the bluntest warnings to the panel came from John A. Gans, CEO of the American Pharmacists Association, who told experts that a true system for ensuring U.S. drug safety "simply does not exist." Gans pushed IOM to take a bottom-up look at drug safety, seeing how patients use-and misuse-medications, factors that are often ignored in the controlled confines of clinical trials. "What we do not assess is medication use in real life," he said.

Gans told the IOM committee that pharmacists "stand ready" to help regulators deliver a new system of safety monitoring that imparts more and better information to patients and helps track how they use their medications. "If we're going to address the consumer, someone's got to be responsible for that. Right now, no body's responsible," he said.