Distribution of Off-Label Drug Information by Pharmaceutical Companies Survey
Survey began 18 February 2008
Survey ended 14 March 2008
The new rules FDA proposes would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.
Under the proposed rule, the agency would let drug and device companies pass out articles to doctors if the articles were peer-reviewed and came from a journal with an expert editorial board. The article must be accompanied by a prominent warning that the use described is not approved or cleared by the F.D.A.
FDA abandoned the requirement that drug and device makers must provide the studies to the agency beforehand or promise to seek approval of the discussed use.
For more background, read the FDA Press Release: “FDA Proposes Guidance for Dissemination of Off-Label Information”
Please take 2 minutes to answer this survey, which asks your opinion specifically of the FDA’s proposed rule and of off-label drug promotion in general.
Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.
More Related Information:
- Guidelines for Off-label Communications Off-label information distribution by pharmaceutical companies to physicians is legal and in common practice, though ‘off-label confusion’ might be the better term. This article reviews several court cases relating to false claims associated with off-label communications and suggests seven steps to safely for marketing a pharmaceutical product for an unapproved indication.