Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the risk of serious health problems arising from off-label uses of the drug.  Douglas S. Ingram, the executive vice president of Allergan, asserts that by allowing off-label drug use but by “prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risks, benefits, and techniques for off-label uses, does not serve the public health or patient care.”   Jeffrey N. Gibbs, a Washington lawyer specializing in food and drug law, asserts this case to be “the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company.  It’s a precedent-setting case.”   Although other pharmaceutical companies have not joined the lawsuit, the outcome will be closely monitored.  An article in the HealthLawProf blog attempts to place this issue into historical context.    It is speculated that Allergan may be utilizing the case to gain leverage with the Agency in negotiating the legal distribution of information on the prevalent off-label uses of drugs, like Botox.  New York Times, 2 October 2009.

What are your thoughts on how best can the pharmaceutical industry distribute safety information on the off-label use of its drugs?

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