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Letter to the editor

FDA may ease way for 'off-label' ads

Journal articles could be used more freely.

The Food and Drug Administration is considering giving drug and medical device companies new leeway to use scientific journal articles to promote their products for unapproved uses, a move critics say would undermine longstanding restrictions on marketing medicines for "off-label" purposes.

The Food and Drug Administration generally prohibits manufacturers from marketing products for any off-label use - those uses that have not been approved as safe and effective. Since 1997, however, Congress has made an exception for journal articles. That law recently expired, and now the agency is trying to put voluntary guidelines in place.

The new guidelines don't include some of the most important protections that Congress had established, said Rep. Henry Waxman, D-Calif. For example, companies previously had to submit reprints of articles to the FDA before they sent the articles to doctors. That way, the accuracy of the articles could be reviewed. The FDA now proposes to let companies send out the articles without getting the agency's approval first.

The guidance "would open the door to abusive marketing practices that will jeopardize safety," said Waxman, chairman of the House Committee on Oversight and Government Reform.

The FDA declined to respond to Waxman's letter. But Dan Troy, a former chief counsel at the FDA, said companies have been distributing medical journals to health care providers for years.

Fast facts

Off-label drugs

Drugs used to treat cancer, such as Avastin, are often prescribed for off-label use. For example, a drug may be approved to treat one type of tumor but soon used by physicians to treat other types.

[Last modified December 1, 2007, 01:21:04]