New ruling on providing “off-label” use drug information

Reports say the U.S. District Court in Washington, DC, has handed down a ruling overturning the U.S. Food and Drug Administration’s policy prohibiting companies from distributing information to physicians on “off-label” use of drugs or devices. Off-label use is use of a drug or device for purposes other than those for which it has been approved by the FDA.

The ruling is the result of a 1994 lawsuit filed by the the Washington Legal Foundation, which claimed that the FDA policy violated the First Amendment rights of companies. Note: physicians have always been able to obtain information on off-label use by request, but companies have been prohibited from providing such information unsolicited. The FDA has reportedly not decided whether or not it will appeal the decision. Data taken from a Reuters news report.

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