fda's off-label guidance under fire

Inpharma 1635 - 26 Apr 2008 FDA’s off-label guidance under fire Proposed guidelines by the US FDA regarding dissemination of journal articles that discuss off-label use of drugs have been criticised, according to an article in JAMA. The draft guidance was issued on February 15 and lays out core principles for companies to follow when distributing journal articles, reprints or reference publications. The material should be peer-reviewed and conflicts of interest should be fully disclosed. According to critics, the draft guidance will allow companies to use peer-reviewed journal articles that support off-label use of their products as a marketing tool. However, the FDA says that it opposes the distribution of publications funded by manufacturers of the products featured in the articles. Dr Michael A Steinman, from the San Francisco VA Medical Center, US, says that this guidance will lead to a lot of problems. "The fundamental issue is that people are viewing reprints as science and they believe that science is objective, but industry uses research to advance marketing goals." According to JAMA, disseminating reprints of scientific articles on off-label use does make sense; off- label drug use is appropriate in many cases, such as in rare diseases. However, off-label use occurs too often in settings where FDA-approved treatments are already available. Critics are afraid that manufacturers will manipulate data and publish trials that support off-label use of their products, and that the guidance undercuts the incentive to conduct rigorous trials to obtain FDA approval for an off-label use. See also Inpharma 1634 p2; 801052524 Mitka M. Critics say FDA’s off-label guidance allows marketing disguised as science. JAMA: the Journal of the American Medical Association 299: 1759-1761, No. 15, 16 Apr 2008 801034998 1 Inpharma 26 Apr 2008 No. 1635 1173-8324/10/1635-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: FDA's off-label guidance under fire

Inpharma 1635 - 26 Apr 2008

FDA’s off-label guidance under fireProposed guidelines by the US FDA regarding

dissemination of journal articles that discuss off-labeluse of drugs have been criticised, according to an articlein JAMA.

The draft guidance was issued on February 15 andlays out core principles for companies to follow whendistributing journal articles, reprints or referencepublications. The material should be peer-reviewed andconflicts of interest should be fully disclosed. Accordingto critics, the draft guidance will allow companies to usepeer-reviewed journal articles that support off-label useof their products as a marketing tool. However, the FDAsays that it opposes the distribution of publicationsfunded by manufacturers of the products featured in thearticles. Dr Michael A Steinman, from the San FranciscoVA Medical Center, US, says that this guidance will leadto a lot of problems. "The fundamental issue is thatpeople are viewing reprints as science and they believethat science is objective, but industry uses research toadvance marketing goals."

According to JAMA, disseminating reprints ofscientific articles on off-label use does make sense; off-label drug use is appropriate in many cases, such as inrare diseases. However, off-label use occurs too often insettings where FDA-approved treatments are alreadyavailable. Critics are afraid that manufacturers willmanipulate data and publish trials that support off-labeluse of their products, and that the guidance undercutsthe incentive to conduct rigorous trials to obtain FDAapproval for an off-label use.

See also Inpharma 1634 p2; 801052524Mitka M. Critics say FDA’s off-label guidance allows marketing disguised asscience. JAMA: the Journal of the American Medical Association 299: 1759-1761,No. 15, 16 Apr 2008 801034998

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