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Patients Often Kept in Dark About 'Off-Label' Drug Use: Study
Date:8/8/2012

re not allowed to promote off-label uses of their drugs. Doing so can result in hefty fines, the study authors explained. For example, GlaxoSmithKline recently agreed to pay a record $3 billion to settle a case involving alleged off-label drug-use marketing, and Merck Sharp & Dohme was fined $322 million for allegedly promoting the painkiller Vioxx for an off-label use.

But, Wittich and colleagues noted, drug companies are allowed to respond to questions from health care providers and distribute peer-reviewed publications about off-label drug use.

The high costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication, the researchers suggested.

More information

The American Cancer Society has more about off-label drug use.

-- Mary Elizabeth Dallas

SOURCE: Mayo Clinic, news release, Aug. 6, 2012


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