Fortuity and the First Amendment - Pharmaceutical Executive


Fortuity and the First Amendment

Pharmaceutical Executive

Under Justice Breyer's view, the FDA can "control in detail just what a pharmaceutical firm can, and cannot, tell potential purchasers about its products." He added that "[i]f the court means to create constitutional barriers to regulatory rules that might affect the content of a commercial message, it has embarked upon an unprecedented task—a task that threatens significant judicial interference with widely accepted regulatory activity." The cited regulations were the FDA rules on off-label marketing.

Because Caronia challenged his conviction soon after Sorrell was decided, his lawyers had little work to do. They simply pointed to Justice Breyer's remarks forecasting invalidation of the FDA off-label rules.

But dissenting opinions are sometimes unreliable predictors of how the majority will rule in a different case. Dissenters often take the logic of the majority a step or two beyond where the majority would go. That might be the case here, because Caronia presents bad facts for defending the speech at issue. Indeed, the case might be regarded as presenting the worst facts imaginable for those hoping to dismantle the FDA's approach.

Caronia was marketing Xyrem, a powerful and fast-acting central nervous system depressant. It was approved by FDA to treat narcolepsy patients, but required a black box warning, the agency's most stern form of safety notification. Xyrem's active ingredient, gamma-hydroxybutryate (GHB), had acquired the infamous street names Grievous Bodily Harm, Liquid Ecstasy, and Georgia Home Boy due to its frequent use in rapes, and it had been federally classified as the "date rape" drug. Caronia's employer, Orphan Medical, Inc., had been acquired by Jazz Pharmaceuticals, a name suggesting that its products might have greater recreational than medicinal value.

To promote Xyrem, Caronia teamed with Peter C. Gleason, MD, a psychiatrist paid by Orphan to appear at its events for doctors. After the government secretly recorded Caronia and Gleason pitching Xyrem for off-label uses, a grand jury indicted Caronia, Gleason, and Orphan. Gleason and Orphan both pled guilty. Jazz agreed to settle, for $20 million, civil claims against it and criminal fines against Orphan. Gleason then committed suicide.

One of the few "good" facts in the case was that the government did not claim Caronia was trying to persuade doctors that Xyrem is a great icebreaker at frat parties. He asked them to consider it for insomnia, fibromyalgia, restless leg syndrome, and Parkinson's. The government argued Caronia was guilty only because the FDA had not approved those uses, not because the drug would be unsafe or ineffective for those uses or that this marketing was a subterfuge for the promotion of unsafe uses.

Neither the bad nor the good facts played much of a role in how the Second Circuit viewed the case. Judge Denny Chin, for the Caronia majority, ruled the conviction could not stand because the government had not shown how prohibiting manufacturers from promoting off-label uses would directly advance public safety or health given that physicians and academics lawfully can advocate those same uses. He also noted that the FDA could combat perceived ill effects of the promotion through its own warnings or requiring disclosures without restricting manufacturer speech.


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