Flash: IOM Issues Half-A-Loaf Drug Safety Report

The Institute of Medicine has just released its long-awaited report on the adequacy of the U.S. drug safety system. While it has some good features, it clearly avoided recommending a radical overhaul of how the Food and Drug Administration does its job.

The report slams the agency for systematically underfunding and understaffing its safety department, and cites organizational and cultural problems that make its voice a secondary concern at FDA. The committee favors "a moratorium on direct-to-consumer advertising," at least when the product is new. But then, they immediately backtracked and cited possible legal impediments to such a stance.

While recommending increased staff and funding, mandatory registration of clinical trials with public access to drug safety information, and better labels, the IOM refused to call for creating an independent safety center outside the arm of FDA that approves new drugs. Safety advocates inside and outside the agency have long pushed for such a move.

No doubt the agency and its protectors inside the pharmaceutical and biotechnology industries will highlight this missing element in the report.