Major Changes Needed In Drug Safety System

The Food & Drug Administration's system for ensuring the safety of new drugs needs a serious overhaul, says a report from the Institute of Medicine. The FDA system for monitoring the safety of drugs after they are marketed is hampered by a lack of clear regulatory authority, chronic underfunding, scarcity of postapproval data, and organizational problems, IOM says.

The committee that wrote the report offered a broad set of recommendations to improve drug safety. For two years after approval, drugs should have a black triangle on the label indicating that the drug is new. The committee also would favor a ban on direct-to-consumer advertising for the first two years, but acknowledged that such a moratorium would be subject to legal challenges. In addition, FDA needs increased enforcement authority and better enforcement tools—including fines, injunctions, and withdrawal of drug approvals—to ensure that industry complies with label changes and conditions imposed on new products after approval. There also should be a mandatory requirement that all Phase II through Phase IV clinical trial results be posted on a federal website to facilitate public access to safety information, the committee says.

"We found an imbalance in the regulatory attention and resources available before and after drug approval," says Sheila P. Burke, deputy secretary and chief operating officer of the Smithsonian Institution and chair of the committee. "Staff and resources devoted to preapproval functions are substantially greater. Few high-quality studies are conducted after approval."

The committee called on Congress to appropriate substantial increases in funding and personnel for FDA. The panel says the additional funding should come from general revenues, not from user fees, which are paid by industry. User fees are now devoted to drug-approval activities.

The advisory committees that recommend drug approvals tend to have too many members with serious conflicts of interest, the report says. It recommends that at least 60% of members of such committees have no financial involvement with companies whose interests could be affected by the deliberations. It also recommends that FDA commissioners be appointed for six-year terms so they will be less subject to the political whims of current Administrations.

In response to the IOM report, acting FDA Commissioner Andrew von Eschenbach says: "Much progress and reform of FDA's safety oversight enterprise is already under way. For example, FDA is developing new tools for communicating safety information to patients."

The Pharmaceutical Research & Manufacturers of America does not see the need for a major FDA overhaul and believes that the agency's drug safety system is basically sound. "Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed. After all, fewer than 3% of approved prescription drugs have been withdrawn from the American market for safety reasons over the past 20 years," says PhRMA Senior Vice President Caroline Loew.