Regulatory Focus™ > News Articles > Bird On a Wire: Potential Individual Liability for Promotion and Marketing of Unlawful Off-Label Us

Bird On a Wire: Potential Individual Liability for Promotion and Marketing of Unlawful Off-Label Use

Posted 01 May 2008 | By

In February 2008, the US Food and Drug Administration (FDA) released Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, contemplating the loosening of restrictions placed on pharmaceutical and medical device companies to promote unapproved, i.e., off-label, uses for approved products. (The document had been percolating for some time and was first publicized in late November 2007 when Representative Henry Waxman (D-CA), Chairman of the House Committee on Oversight and Government Reform, wrote a letter to FDA urging the agency not to go forward with the draft guidance and then posted the draft guidance on the House Committee's website.) This draft document contains a proposal that would permit, if certain conditions are met, medical device and pharmaceutical companies to distribute proactively to healthcare professionals journal articles and other publications that discuss unapproved new uses of approved products. Ironically, at the same time FDA is considering relaxing prohibitions on a company's ability to market (or at least inform healthcare providers of research surrounding) off-label indications, the Department of Justice has increased interest in investigations into companies that may be supplying healthcare professionals with such information as part of their marketing. Notably, in addition to focusing on corporate liability exposure, these investigations present risks of individual liability and, in fact, the government has demonstrated its willingness to prosecute individuals.

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