Resources for Food and Drug Administration (FDA)

FDA and Drug Marketing

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The Food and Drug Administration is developing a proposal for how drug companies can inform doctors about drug uses that aren't FDA approved, a contentious but important area of promotion for the industry.

While it is legal for physicians to prescribe drugs or use medical devices in ways not specifically approved by the FDA, companies that make the products aren't allowed to market such practices. A number of drug makers have been prosecuted for allegedly pushing to increase "off-label" use.

According to a draft of the proposal, the FDA is considering guidelines that would say manufacturers may give doctors articles from medical journals and materials drawn from scientific reference texts that discuss off-label uses of drugs and medical devices.

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