Peter Gleason was a psychiatrist who devoted much of his professional life to caring for what government officials call "underserved populations." He would have been thrilled to learn that on Dec. 3 in New York, a three-judge panel of the U.S. Court of Appeals for the Second Circuit issued a ringing opinion that vindicated the conduct for which he was indicted and arrested in 2006.
Unfortunately, Gleason did not live to see this welcome reversal of the federal government's crusade against him and the promotion of Xyrem--a drug widely used by physicians, including Gleason, to treat a number of medical conditions beyond what the federal Food and Drug Administration approved it for. Hounded for years, he saw his career and finances ruined by the relentless war waged against him by FDA bureaucrats and Justice Department prosecutors. Gleason committed suicide on Feb. 7, 2011.
Silverglate neglects to mention that the panel was actually divided 2-1. The opinion is here. The majority's concluding paragraph reads:
Accordingly, even if speech can be used as evidence of a drug's intended use, we decline to adopt the government's construction of the FDCA's misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech. We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs. Our conclusion is limited to FDA-approved drugs for which off-label use is not prohibited, and we do not hold, of course, that the FDA cannot regulate the marketing of prescription drugs. We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.The opinion strikes me as narrower and less "ringing" than one would gather from Silverglate's description. Nonetheless, it does move the ball in the direction of less regulation, and less criminalization, of commercial speech. Given the importance of the subject and the fact that the panel was divided, further review en banc or in the Supreme Court is a substantial possibility.