Off-Label Use
This article was originally published in RAJ Devices
Executive Summary
US FDA accused of withholding information on distribution of journal articles promoting off-label uses
US FDA accused of withholding information on distribution of journal articles promoting off-label uses
The US Food and Drug Administration has failed to co-operate with a congressional investigation into its policy on the distribution of journal articles promoting off-label uses, according to Representative Henry Waxman (Democrat - California)1. The chairman of the Committee on Oversight and Government Reform made the allegations in a letter to FDA commissioner Andrew von Eschenbach after the agency refused to provide certain information relating to draft guidance on the issue.
The guidance, which has not been officially released, proposes to allow pharmaceutical and medical device companies to send doctors reprints of articles to inform them about unapproved uses of their products. The committee is investigating the draft because of concerns that it is being prepared to protect industry from prosecution for illegally promoting unapproved uses, and not to advance public health.
In the letter, Representative Waxman asked the agency to provide his office with all documents and communications between 26 January 2001 and 13 April 2007 relating to the dissemination of reprints and textbooks, as well as all communications with persons outside the executive branch dating back to 26 January 2001 relating to the draft guidance or the issue in general. He requested that the information be furnished by 5 February.
Representative Waxman had written to Dr von Eschenbach in November 2007 requesting a copy of all internal written and electronic documents relating to the guidance and information on how the guidance addresses policy concerns relating to illegal promotion of off-label uses2. The letter also asked that the agency refrain from publishing what he called the “ill-advised“ guidance.
The FDA responded in December by giving the committee the minutes to a 13 April 2007 meeting between agency officials and industry representatives that briefly mentioned the issue. However, the agency refused to provide any of the other information, arguing that the “the document in question is a draft of a draft guidance”, which, assuming it completes internal review, would be issued for public comment, not for implementation. The agency added that it could not disclose what it considered to be “deliberative pre-decisional information” because of the detrimental effects it could have on the vetting process for guidance documents.
Representative Waxman said in his letter that this was no basis for withholding the materials from the committee, particularly where there is evidence that the agency's actions may be unduly influenced by regulated companies.
References
1. Representative Waxman letter to FDA commissioner, 22 January 2008, http://oversight.house.gov/documents/20080122141935.pdf
2. The Regulatory Affairs Journal - Devices, 2008, 16(1), 57-59
3. FDA response to 30 November request for documents, 21 December 2007, http://oversight.house.gov/documents/20080122142141.pdf