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Helen Zukin
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Scientific Panel Concludes Food & Drug Administration Needs Reform

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Blue ribbon panel criticizes FDA and calls for reform of agency. Drug safety monitoring needs complete overhaul.

A blue ribbon panel of scientists issued a highly critical report on Friday, on the health of the FDA. The report, requested by the FDA after VIOXX, a much used painkiller, was linked to heart attacks, concluded that the FDA has a number of serious problems which need immediate attention.

The FDA has come under increasing criticism, and calls for its overhaul, after a number of popular medicines have been connected to serious adverse health effects in users. Among the FDA’s regulatory responsibilities are to license new drugs and to monitor existing medications for health risks. The scientific panel found the FDA‘s ability to monitor prescription drugs to be unsatisfactory, in part, due to a lack of resources.

“Staff and resources devoted to pre-approval are substantially greater than those available post-approval.”

In addition it stated,

“The committee found that the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture that is not optimally functional; and unclear and insufficient regulatory authorities, particularly with respect to enforcement.”

Some of the reports recommendations for strengthening the FDA’s drug safety oversight are to:

1. Expand the FDA’s databases for tracking adverse reactions to prescription drugs.
2. Put a symbol on packaging of new drugs for two years to alert the public.
3. Give FDA authority to command drug manufacturers to conduct safety studies on their products.

Kiesel Boucher Larson, LLP has expertise in the field of defective drug litigation. The firm currently represents numerous victims in a variety of defective drug cases; including cases involving the painkiller VIOXX.