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"
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