Drug and Device Companies Can Speak Up About Off-Label Uses —Within Limits, Hurd Says
Washington, D.C. (PRWEB) July 29, 2013 -- The First Amendment protects some forms of commercial speech. But to what extent does it give pharmaceutical and medical-device companies the right to promote unapproved, “off-label” uses of their products? In an hour-long webinar recorded July 18, LeClairRyan attorney Patrick J. Hurd explored the relevant case law—and looming regulatory uncertainties—associated with this important question.
“Doctors aren’t prohibited from prescribing drugs and devices for off-label uses,” noted the veteran healthcare attorney, senior counsel in the national law firm’s Norfolk, Va., and Washington, D.C. offices. “But if they are to provide such prescriptions to their patients, doctors need a thorough understanding of, and solid scientific evidence about, the safety and efficacy of those off-label uses.” And herein lies the problem, Hurd explained. “Because drug companies are prohibited from ‘promoting’ off-label uses, they often fear that any information they give to doctors along these lines will be deemed promotional by regulators and therefore out of bounds,” he said. “This has created tremendous uncertainty, and the industry is clamoring for clearer guidance.”
In the absence of clear FDA rules on these issues, the webinar—“Can FDA Handle the Truth? Free Speech and Off-Label Marketing of Drugs and Devices”—outlined a prudent course for drug and device companies to take in light of key federal court decisions. The hour-long recording is available as a free download at LeClairRyan.com. It begins with a discussion of the origins of FDA’s tough stance on off-label promotions, which Hurd argues is understandable given the events of the 1960s and ’70s. “Today’s regulators well remember the harm caused by the likes of thalidomide and the Dalkon Shield, and they live in fear of another off-label debacle occurring on their watch,” Hurd noted. “Their institutional memory includes an era when drug manufacturers were seen as frequently making unsupported, if not untruthful, claims about new uses.”
This helps explain the stiff criminal and civil enforcement that continues to characterize FDA’s expansive definition of “labeling,” Hurd said. “Indeed, as many First Amendment scholars have observed, drug and device promotional materials continue to be among the most heavily regulated communications in the United States,” he noted.
In the webinar, Hurd catalogued a host of cases in which FDA aggressively targeted drug and device companies that it said flouted the law and misled the public. In the 7th Circuit case United States v. Caputo, for example, executives at Abtox, Inc., were convicted of multiple counts of fraud, sentenced to prison terms and ordered to pay restitution of $17.2 million to 144 hospitals. The case hinged on off-label claims about Plazlyte, a device formerly used to sterilize medical instruments. “These executives were accused of ignoring studies showing product failures and aggressively marketing Plazlyte for unsafe uses even in the face of FDA warning letters,” Hurd said. “The court described these corporate crimes as egregious.”
But the attorney also covered federal cases, including U.S. v. Harkonen and U.S. v. Caronia in which courts have upheld companies’ right to provide truthful information about off-label uses of their products. “In Harkonen, for example, the court ruled that communications about off-label uses of drugs and devices constitutes commercial speech as protected by the First Amendment,” Hurd said. “False, fraudulent statements are another matter. But the court felt that the statements the drug company was making were truthful and that it was not a crime to make truthful statements in the marketplace,” Hurd said.
FDA has promised to provide further guidance. Until this happens, however, such cases suggest that drug and device companies should stick to the scientifically proven facts supported by published studies when communicating information about off-label uses, Hurd said. “The average citizen enjoys freedom of speech under the First Amendment, but people can’t yell ‘Fire!’ in a crowded theater,” Hurd noted. “Likewise, drug and device makers cannot mislead the public in ways that could cause harm. But this does not mean they must keep their lips sealed. When doctors want the facts, companies have every right to speak up—so long as they speak the truth.”
About LeClairRyan
As a trusted advisor, LeClairRyan provides business counsel and client representation in corporate law and litigation. In this role, the firm applies its knowledge, insight and skill to help clients achieve their business objectives while managing and minimizing their legal risks, difficulties and expenses. With offices in California, Connecticut, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Virginia and Washington, D.C., the firm has approximately 350 attorneys representing a wide variety of clients throughout the nation. For more information about LeClairRyan, visit http://www.leclairryan.com.
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Press Contacts: At Parness & Associates Public Relations, Marty Gitlin (631) 765-8519, or Bill Parness, (732) 290-0121, parnespr(at)optonline(at)net
Bill Parness, Parness & Associates, 732-290-0121, [email protected]
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