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FDA
FDA Launches New Website
The U.S. Food and Drug Administration has begun issuing alerts to patients and doctors on its Web site about emerging drug-safety concerns, including dangers posed by drugs prescribed for unapproved purposes. The new site, called Drug Watch, marks a significant change in how the agency communicates risks to the public. In the past, the FDA has spent months or years privately weighing and debating risk information with drug companies until a final determination was made on the scientific significance of the danger.
After being bashed by Congress and consumers for its slow response to emerging information about heart risks posed by blockbuster pain medications such as Vioxx, the FDA now is beginning to make risk information available to the public much sooner.
The safety alerts posted so far on the site - http://www.fda.gov/cder/drugSafety.htm - are notable also because they emphasize risks posed by doctors prescribing drugs for purposes never approved by the FDA. It's a practice called "off-label prescribing" because it involves using drugs in ways and to treat conditions not covered by the safety and effectiveness determinations on their FDA-approved labels.
Some off-label drug uses are beneficial and based on good science, others have little proof of effectiveness and still others have been proved worthless in studies. Officials at the American Medical Association, which represents doctors, and the Pharmaceutical Research and Manufacturers of America, which represents drugmakers, declined to comment, saying they are evaluating the Drug Watch site and will submit formal comments to the FDA.
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