The story of the late Dr. Peter Gleason, a Maryland psychiatrist who devoted much of his practice to serving the poor and underserved populations, is a tragic reminder of the real-life impact that overcriminalization can have on individuals.
Before a drug can be sold in the United States, it must first be evaluated by the Food and Drug Administration (FDA). A pharmaceutical company submits a drug to the FDA along with a claim of the drug’s benefits. In a long and expensive process, the FDA then tests the drug for its effectiveness and safety.
Oftentimes, a drug will have benefits beyond its original purpose; this is commonly referred to as the drug’s “off-label” use. Under FDA regulations, a pharmaceutical company is prohibited from promoting a drug for a use that the FDA has not approved. Doctors, on the other hand, are not prohibited from touting a drug’s “off-label” use.
Because of this distinction, Dr. Gleason believed that it was perfectly appropriate and legal for him to discuss the “off-label” benefits of a drug he was promoting. The government did not agree. Federal agents arrested Dr. Gleason in March 2006 and subsequently charged him with violating the FDA regulation against promoting a drug’s “off-label” use.
The government’s theory was that, because a pharmaceutical company paid Dr. Gleason to promote the drug, he was no longer exempt from the “off-label” rule. Mind you, the FDA never argued that Dr. Gleason’s statements about the drug harmed anyone or that his statements were untrue, but that didn’t stop an assistant FBI director from publicly comparing Dr. Gleason to a “carnival snake-oil salesman.”
Dr. Gleason’s assets were frozen and his practice was ruined. In order to avoid the uncertainty of a criminal trial, Dr. Gleason pleaded guilty to a misdemeanor and, as a result, was no longer eligible to receive payments from the Medicare and Medicaid programs. Effectively deprived of his ability to help people while earning a living at his chosen profession, Dr. Gleason spiraled into depression and took his own life.
Dr. Gleason’s co-defendant, a pharmaceutical representative, appealed, and the U.S. Second Circuit Court of Appeals reversed his conviction, holding that the government violated the defendant’s constitutional right to free speech under the First Amendment and had overreached by prosecuting him (and, by extension, Dr. Gleason) for truthful, non-misleading speech.
While Dr. Gleason’s co-defendant—after much time, effort, and anxiety—was able to clear his name, the story obviously did not end well for Dr. Gleason. What many fail to realize is that investigations, prosecutions, and appeals can take years to resolve. In the meantime, when the government overreaches, as it did in this case, real people can be hurt financially, mentally, and spiritually—sometimes, as in the case of Dr. Gleason, with devastating and irreparable results. This is the danger of overcriminalization: It ruins lives.