April 14, 2008
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket Number FDA-2008-D-0053
Comments submitted by Breast Cancer Action on FDA Guidance for Industry on Reprint Distribution Practices
Women receiving treatment for advanced breast cancer are frequently given drugs that are not approved for use for their specific condition. Above all else, Breast Cancer Action (BCA) considers accurate informed consent to be the bottom line for people in treatment. FDA’s proposed Guidance for Industrydoes not promote increased accuracy or availability of information that would allow those with breast cancer to make better treatment decisions. What it does allow is broader marketing of products of dubious value or safety by lessening regulatory controls.
Many of the drug safety concerns of the past decade have been related to deceitful practices on the part of pharmaceutical companies, including withholding significant safety information from FDA and from medical journals, distorting direct-to-consumer ads to inflate perceived benefit or minimize perceived risk, interfering with company sponsored studies carried out by presumed independent researchers, and even ghost writing articles for willing academic physicians to promote their products.
There is ample research that shows that drug company-sponsored research rarely shows results that would question use of their products. This kind of research often does get published in peer-reviewed journals. The strictures set out in the proposed Guidance, by no longer requiring FDA review of articles to be distributed, will certainly result in dissemination of studies that are not well-controlled and that will report outcomes of dubious reliability. Likewise, the proviso that companies include an article representing contrary findings can and will be read and followed selectively by the companies.
Further, eliminating the stipulation that companies that wish to distribute literature showing benefits of off-label uses of their products must submit a timely New Drug Application for those uses will remove any incentive for the companies to carry out carefully controlled research to show safety and effectiveness.
BCA is very pleased that FDA has recently shown an increased commitment to post-market surveillance. The proposed Guidance would undermine this commitment and diminish FDA’s role in assuring the safe and effective use of products after they have been approved.
We strongly recommend that FDA not alter the original Guidance that was issued in 1997, and increase enforcement of its provisions.
Respectfully submitted,
Barbara A. Brenner
Executive Director
Breast Cancer Action
Jane Zones
Board Member
Breast Cancer Action
As a matter of policy, in order to avoid the fact or appearance of a conflict of interest, Breast Cancer Action does not accept funding from any pharmaceutical companies.
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