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Drug agency needs big dose of reform

A Times Editorial
Published October 31, 2006


The good news is that Lester M. Crawford is out as the commissioner of the Food and Drug Administration, and he is certain to be punished for lying and conflict-of-interest charges in connection with stocks he and his wife owned in businesses he regulated. The bad news is that Crawford, a Bush administration appointee, left the once-trusted watchdog agency in turmoil, thereby threatening the health and safety of American citizens.

A new report by the Institute of Medicine, a prestigious panel of experts who advise the nation on significant health concerns, suggests that highly publicized drug fiascos, such as the withdrawal of Vioxx following claims that several patients died from using the drug, have given "a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry." The IOM further suggests that the FDA's failure to catch the impending Vioxx scandal bolsters doubts about the agency's ability to safeguard the public health.

The report indicates that the FDA's crippled drug safety system is failing because of poor management, low morale, infighting, insufficient regulatory authority and a lack of funds to carry out its mission. The IOM is particularly troubled that the FDA fails to "consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion." One unfortunate result is that patients who have bad experiences with their medications - for lack of adequate information - lose confidence in their drugs and stop taking them altogether.

The challenge is to revive confidence in the agency. For starters, the IOM recommends that both physicians and patients be given better information about the risks, benefits and side effects of drugs. To accomplish this, the panel wants a moratorium on advertising during the first two years after a drug is put on the market. As is too often the case, labels on new drugs often omit information about side effects. The IOM wants a special symbol on all new drugs when they go on sale. The pharmaceutical companies, not worried about robust disapproval from the Bush White House, are fighting these proposed changes.

Protecting the integrity of nation's drug safety system should not be left to political appointees with ties to the pharmaceutical companies they regulate. The Bush administration can do better. It must do better.

[Last modified October 31, 2006, 01:48:51]

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