FDA lacks funds, authority to ensure drug safety- Panel

A not-for-profit, non-govermental American Scientific panel said Friday, that the U.S government's drug safety system is in a serious state of deterioration, focusing more on the approval of new medications and not doing enough follow up to uncover risky side effects.

The Food and Drug Administration (FDA) has neither the monetary resources nor the authority to sufficiently monitor licensed prescription drugs and make certain that they are safe, a committee of the Institute of Medicine (IOM) declared in its long awaited major report, released yesterday.

Convoked at the request of the FDA after a widely known pain relieving drug, Vioxx, was linked to heart attacks, a 15 member panel of experts in medicine, pharmacology, law and other fields issued a comprehensive call for reform. The committee suggested that a host of dramatic changes are needed to fix the problem. Its 25 recommendations for the reform include establishing a fixed term for the FDA commissioner, restricting ubiquitous drug commercials and drawing a special cautionary symbol on the packaging of newly approved medications.

In a broad-spectrum criticism of federal drug regulation, the committee also called on Congress to increase the agency's funding, restrict drug advertising and require manufacturers to make public the data they obtain from clinical trials.

The committee is a part of the National Academies, chartered by Congress and its purpose is to provide national advice on issues relating to biomedical science, medicine, and health. Its recommendations traditionally carry high significance.

Consumer organizations and supporters of making extensive renovations in the policies of the FDA saluted the report, on the other hand, the drug industry was unwilling to accept this. At the same time, FDA officials said they will take the report seriously, but also said repairs implemented during the past year make the report somewhat out of date.

The pharmaceutical industry also has re-verberated the agency's response. "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," said Caroline Loew, vice president of the Pharmaceutical Research and Manufacturers of America. "After all, fewer than 3 percent of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years."

On the whole, the major report concluded that the FDA needs more money, manpower and authority to ensure it maintains focus on the safety of the drugs it regulates throughtout the time they are in the market. The agency also needs cultural changes to avoid the tensions that can upset the weighing of drugs' risks and benefits. "We found an imbalance in the regulatory attention and resources available before and after approval," said Sheila Burke, chairwoman of the panel. "Staff and resources devoted to pre-approval functions are substantially greater."

Impressed with the panel's effort, Acting Commissioner Andrew Von Eschenbach said it will take time to study the findings. "We are at a point where we are assessing and analyzing the report," he said.