The Dangers of the FDA’s Regulatory Hegemony

In March, Arizona became the first state to pass a bill allowing the free flow of medical information between drug companies and physicians. The Free Speech in Medicine Act, which was passed unanimously in both state houses, may seem curiously innocuous: It simply permits pharmaceutical companies to share information with licensed health-care professionals, provided the information is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles.” So far, so good—one might rightly assume that relaying information would be permissible with or without legislation.

However, FDA regulations largely prohibit pharmaceutical companies from discussing safe and effective uses for FDA-approved drugs, unless those uses have been specifically sanctioned by the agency. For example, if the FDA approved a certain drug as a headache treatment, drug company representatives could not recommend that drug as a treatment for muscle pain, even if substantive data showed that it treats muscle pain effectively. Instead, the company would need to apply and pay for a separate FDA trial to approve that use. In practice, this means that information on effective treatments is often deliberately concealed from doctors, despite the fact that they are free to prescribe FDA-approved medicines for virtually any purpose they see fit.

The FDA has good reason for seeking to suppress information about off-label use. As long as companies must seek FDA approval for every narrow application of a “multi-purpose” drug, the agency will have access to an enormous source of revenue—the user fees companies pay to the FDA during drug trials. This policy also grants the agency enormous authority, as the FDA largely controls what medical information reaches the public. To maintain this arrangement, the FDA has led a number of disturbing prosecutions, not least of which began over a decade ago and ended in a court decision that may significantly affect the agency’s future.

On a March afternoon in 2006, Dr. Peter Gleason was standing on a train platform in Long Island, New York, when a group of men in suits surrounded and handcuffed him. According to a New York Times report, he initially thought it was all a “gag.”

Gleason was shocked when he was charged with doing something that the Times admitted is common among doctors: “promoting a drug for purposes other than those approved by the federal government.” He had been an early fan of the drug Xyrem—approved by the FDA in 2002 to treat narcolepsy—and had begun prescribing it for a variety of conditions, including depression and insomnia.

Noting Gleason’s high rate of Xyrem prescriptions, a representative from Xyrem’s manufacturer, Orphan Medical, asked him if he would speak to other doctors about the drug. Gleason agreed, and began giving paid talks at Orphan-sponsored events. Gleason thought—correctly, it turned out—that he was acting within his rights when he explained the multiple health issues he thought Xyrem could effectively treat.

Tragically, Gleason took his own life months before his actions were vindicated by a 2012 ruling from the U.S. Court of Appeals for the 2nd Circuit. Starting in 2005, the FDA had recruited Dr. Stephen Charno to attend Orphan conferences and tape conversations in which he asked Gleason about effective uses for Xyrem. These conversations were used as evidence against Gleason when he was arrested and charged with a misdemeanor for truthfully answering another doctor’s questions.

Based on this evidence, FBI Assistant Director Mark Mershon attacked Gleason’s character, comparing him to a “carnival snake-oil salesman” who was “[apparently] motivated solely by greed,” in a 2006 press release. Gleason was publicly disgraced, and his practice began to fall apart. While Orphan Medical agreed to pay a $20 million settlement, Gleason’s medical license was suspended in two states, his assets were frozen, and the fact that he pleaded guilty to a misdemeanor charge meant he could no longer receive payments from Medicare and Medicaid. In his own words, “I disseminated truthful peer-reviewed information about the off-label uses of FDA approved drugs to fellow physicians at CMEs and company-sponsored promotional when asked. I placed too much trust in the quality assurance and compliance program of Jazz/Orphan Medical. I should have assumed that role myself.” But, as Gleason repeatedly noted, he was “never accused of providing fraudulent information.”

While the 2nd Circuit ultimately ruled in his favor in U.S. v. Caronia, the FDA had already made an example out of Gleason by intimidating him and destroying his livelihood. Gleason had been unable to restore his suspended license in Pennsylvania, which significantly hindered his ability to practice medicine. Although the court determined that physicians who do not directly represent drug companies may say whatever they wish to about drugs, neither doctors nor pharmaceutical companies were likely to be encouraged by Gleason’s ordeal. The FDA’s power grab thus resulted in more than a few casualties: Gleason; his family, patients, and loved ones; and other physicians who seek to provide their patients with the best possible medicine without fear of government intrusion or prosecution. As Gleason’s sister Sally insisted, “The over-reaching powers of a federal prosecutor and the [Department of Justice] led to his suicide after five years of their torment.”

Sally Gleason Goodson also cited the Supreme Court case Sorrell vs. IMS Health—in which the majority ruled that a Vermont statute affecting pharmaceutical marketing violated the First Amendment—as proof that her brother “never should have been arrested for speaking truthfully to his fellow physicians about the off-label uses of an FDA approved drug—anywhere or any time.”

Despite the 2nd Circuit ruling, the FDA’s Office of Criminal Investigations continues to list “Off-Label promotion of FDA approved drugs and medical devices” as one of the legal “violations” they are charged with investigating. This is clearly at odds with the court’s decision, but not at all surprising. The First Amendment hasn’t stopped the FDA from interfering in the flow of information between drug companies and doctors, and many companies have agreed to settlements of hundreds of millions or even billions of dollars to the government rather than engage in protracted court battles to defend themselves.

In his psychiatric practice, Gleason assisted people who were desperate—individuals who were depressed, bipolar, or suicidal. It is tragic that he succumbed to the sort of suffering he helped alleviate for so many. Arizona’s bill, while modest, is an important first step in drawing attention to this issue and encouraging nationwide reform in protecting the rights of physicians to receive or disseminate truthful medical information.

Devorah Goldman is an assistant editor at National Affairs.

This post originally appeared on Weekly Standard


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