IOM Report Recommends Overhaul of FDA

WASHINGTON, Sept. 22 -- The Institute of Medicine has taken the FDA to the woodshed with a scathing report issued today that found the agency had lost credibility in its regulation of the pharmaceutical industry.

The IOM report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, was drafted at the behest of the FDA and the Department of Health and Human Services.

It called for the restoration of the "appropriate balance between the FDA's dual goals of speeding access to innovative drugs and ensuring drug safety over the product's life-cycle." Among the reforms proposed by the IOM was a reevaluation of new drugs five years after approval, made on the basis of post-marketing studies.

"The FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval." the report said.

The IOM report also proposed that the FDA commissioner be appointed to a six-year term, a way of resolving the pervasive perception that politics intrude on science in decision-making, The appointment would still be made by the President, subject to the advice and consent of the Senate.

Moreover, the IOM recommended that a President could only fire an FDA commissioner for "reasons of inefficiency, neglect of duty, or malfeasance in office."

In all, the committee made 25 recommendations to improve FDA operations from the earliest stage of clinical trials through post-market surveillance.

Among those recommendations:

• New drugs, new combinations of active substances, and new systems of delivery of existing drugs, should be required to carry a special symbol of their labels for two years.
• During those two years there should be no direct-to-consumer advertising.
• There should be beefed up authority for the agency, including stronger enforcement tools.
• Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits,
• Mandatory registration of clinical trial results to facilitate public access to drug safety information
• An increased role for FDA's drug safety staff

In a statement released with the report, the IOM said its committee found:

• There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.
• The FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.
• Most stake holders--the agency, the industry, consumer organizations, Congress, professional societies, and health care entities--appeared to agree on the need for certain improvements in the system.
• The drug safety system is impaired by serious resource constraints that weaken the quality and quantity of the science that was brought to bear on drug safety.
• There is an organizational culture in the Center for Drug Evaluation and Research that was not optimally functional. There was unclear and insufficient regulatory authority, particularly with respect to enforcement.