In January of this year, the pre-Obama Food and Drug Administration approved a guidance giving drug industry representatives the right to distribute journal articles to physicians as long as they came from peer-reviewed journals and reflected well-controlled science. When this policy was first proposed in February 2008, this blog referred to the proposal as a "lack of evidence-based medicine" policy.

I was glad to see earlier this week that the new team at FDA ignored that policy by sending a warning letter to Sanofi-Aventis for distributing a journal article at last year's American Society of Clinical Oncology meeting that suggested its chemotherapy drug Taxotere was superior to the generic paclitaxel. The study, which appeared in the prestigious Journal of Clinical Oncology, did not have statistical significance in its primary endpoint -- time to progression of cancer -- but did show statistical significance in some of its secondary endpoints, which included survival.

In the letter, the FDA said:

In the absence of a finding of statistical significance for the primary endpoint, any further analysis conducted on this study, including secondary endpoints and subpopulations, are all considered exploratory and do not generally constitute substantial evidence.

Sanofi-Aventis told Reuters it will defend its reprint distribution practices since it was "based on current FDA promotion and advertising regulations," even though, according to the FiercePharma blog, the company has stopped distributing that particular study.

Memo to FDA: The agency should officially withdraw the "good reprint practices" guidance and rewrite it to reflect the rigorous scientific standard used by the Division of Drug Marketing, Advertising and Communication in its letter to Sanofi-Aventis.