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FDA Plans To Post List Of Drugs Under Investigation

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The Washington Post

Published: September 6, 2008

WASHINGTON - The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said Friday. A listing doesn't mean the drug is unsafe, only that the FDA is looking into that possibility.
FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

The agency's Adverse Event Reporting System last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medicine a patient was taking.

Presumably, many of the investigations that the FDA will now announce will not find any new problem with the drug in question.

"The risk is that people will read more into this than what it is, which is a statement that an evaluation is under way," said Paul Seligman of the agency's Center for Drug Evaluation and Research. He added he hoped patients would not stop taking a medicine simply because they saw it on the list.

Another official, Gerald Dal Pan, said that the FDA's "post-market surveillance" system is not changing, only the timing and extent to which the public is informed.

"I think the public has told us in recent years that 'we want to know what you are working on.' We are telling the public at pretty much the earliest stage what we are working on," he said.

A drug is evaluated for safety in many ways in the long process leading to the FDA's decision to approve or reject it for sale. Nevertheless, rare side effects and interactions sometimes are not recognized until after a drug is on the market and taken by many more people, and people with more health problems, than those in premarket studies.

The quarterly list, which can be found on the FDA Web site, will name only drugs being reviewed because of reports to the adverse event program. The agency also starts investigations because of data from clinical trials and other studies. Those will not be on the list.

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