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FDA Guidance On Drug Maker, Doctor and On Off-Label Uses Of Treatments

Armen Hareyan's picture

FDA might allow pharmaceutical and medical devicecompanies to send physicians studies on off-label uses of medications, a movethat "would be a break with the FDA's prohibition on the marketing ofdrugs and medical devices for unapproved purposes," the Washington Post reports. Currently, physicians canprescribe medications and medical devices for off-label uses, but companiescannot market their products for such uses.

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

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


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However, in a letter senton Friday to FDA Commissioner Andrew von Eschenbach, House Committee on Oversight and GovernmentReform Chair HenryWaxman (D-Calif.) said that the draft guidance "would open the door toabusive marketing practices that will jeopardize safety, undermine publichealth and lead to an increase in unapproved uses of powerful drugs" (WashingtonPost, 12/1). He added that the draft guidance "puts the public atrisk of ineffective and dangerous uses of drugs" (Carey, CQ HealthBeat, 11/30).

According to Waxman, the draft guidance would make companies less likely toapply for FDA approval for expanded uses of medications and medical devices.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

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

Ken Johnson, senior vice president of the PharmaceuticalResearch and Manufacturers of America, declined to comment specifically on the draftguidance but said such a proposal could help physicians make more informeddecisions about which medications toprescribe (Washington Post, 12/1).

Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily Health PolicyReport is published for kaisernetwork.org, a free service of The Henry J.Kaiser Family Foundation.