FDA Draft 'Guidance' Would Allow Drug Makers To Distribute To Physicians Reprints Of Studies On Off-Label Uses Of Treatments

Main Category: Primary Care / General Practice
Also Included In: Public Health;  Pharma Industry / Biotech Industry
Article Date: 04 Dec 2007 - 5:00 PDT

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FDA might allow pharmaceutical and medical device companies to send physicians studies on off-label uses of medications, a move that "would be a break with the FDA's prohibition on the marketing of drugs and medical devices for unapproved purposes," the Washington Post reports. Currently, physicians can prescribe medications and medical devices for off-label uses, but companies cannot market their products for such uses.

Under a draft "guidance" prepared by FDA, companies could send physicians unabridged reprints of studies on off-label uses of medications published in peer-reviewed medical journals, provided that they are not "significantly influenced" by the companies or individuals with financial ties to them. Companies could not send promotional materials with the studies, which would have to include labels to indicate that they examine off-label uses of medications (Lee, Washington Post, 12/1). Companies also could not send letters to the editors of medical journals. In addition, "if the conclusions in a particular article have been disputed, it would have to be distributed along with another article showing the opposing view," the Wall Street Journal reports.

According to the Journal, the "FDA's draft proposal seems to try to strike a middle ground, allowing companies to distribute information about off-label uses but setting limits on the practice" (Wilde Mathews, Wall Street Journal, 12/1).

Criticism
However, in a letter sent on Friday to FDA Commissioner Andrew von Eschenbach, House Committee on Oversight and Government Reform Chair Henry Waxman (D-Calif.) said that the draft guidance "would open the door to abusive marketing practices that will jeopardize safety, undermine public health and lead to an increase in unapproved uses of powerful drugs" (Washington Post, 12/1). He added that the draft guidance "puts the public at risk of ineffective and dangerous uses of drugs" (Carey, CQ HealthBeat, 11/30).

According to Waxman, the draft guidance would make companies less likely to apply for FDA approval for expanded uses of medications and medical devices. He also wrote that studies published in peer-reviewed medical journals do not ensure the safety of off-label uses of medications and medical devices. Waxman wrote, "While there may need to be a balance between First Amendment and protection of the public health, the answer is not to open the door to unrestricted dissemination of potentially questionable information about drug safety and effectiveness." Waxman asked von Eschenbach to suspend the draft guidance and cooperate with a committee investigation of the issue (Washington Post, 12/1).

FDA spokesperson Christopher Kelly said that the agency will review the letter from Waxman and "respond directly to the congressman" (CQ HealthBeat, 11/30).

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, declined to comment specifically on the draft guidance but said such a proposal could help physicians make more informed decisions about which medications to prescribe (Washington Post, 12/1).

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