Off-Label suit by drug manufacturer

The FDA rules prohibit manufacturers from advertizing drugs for conditions and in dosages for which the drugs have not been tested. Those rules protect the public by requiring that pharmaceutical companies do the clinical studies necessary to support that drugs are safe and effective before marketing the drugs. Allergan Inc., the maker of Botox has sued the FDA in U.S. District Court for the District of Columbia claiming that the FDA’s off-label marketing restrictions violate Allegran’s constitutional right to free speech.

Health care in the US will suffer if manufacturers are allowed to market drugs for untested uses and in dosages that have not proven to be safe. If the suit is successful promotional materials will inevitably provide a strong sales pitch but contain disclaimers providing in essence that you prescribe or take the drug at your own risk.

If Alergan’s suit is successful the burden of protecting patients from unsafe drugs will shift to the physician. Busy physicians simply do not have the time to carefully parse advertisements to determine what conditions and in what dosages the drug has proven effective. The drug companies have the incentive, resources and moral obligation to get FDA approval before telling doctors and the public that a drug is save.

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