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Court: off-label marketing ok

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Last week, a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan ruled that off-label drug marketing by drug reps amounts to ‘free speech’.

Under federal laws, once the FDA approves a drug, physicians are free to prescribe that drug as they wish,  but the drug manufacturer can only market the drug for the FDA-approved marketing indication(s).

The ruling most likely opens the door for pharmaceutical companies to aggressively market their drugs for a wide variety of indications that are NOT approved by FDA.   If upheld by the Supreme court, the ruling will also likely lead to massive direct-to-consumer media campaigns by pharmaceutical companies.

The test applied by the Court of Appeals relies upon the truthfulness of off-label statements made by drug representatives.  It is considered free speech, the court’s decision implies, if an off-label claim is based on a belief that a given drug is effective.  But the Court of Appeals did not address the necessary means to establish effectiveness and the safety of such claims, which is usually accomplished through comprehensive clinical trials with FDA-approved study designs.  It is conceivable that under the new ruling, unfounded studies with substandard data similar to ones produced by Dr. Goldstein in support of Seroquel – an anti-psychotic drug, claiming its effectiveness in lowering blood glucose and leading to weight loss – could be the new standard of marketing drugs without fear of legal accountability.

Hopefully, the Supreme Court will exercise better judgment than the lower court, and consider the rights and well-being of patients vs. so-called ‘free speech’ in advertising, with its potential to injure millions of people.


by Matthews & Associates

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