Clash Over Regulation of “Off-Label” Promotion of Drugs and Devices

A 2012 decision from the U.S. Court of Appeals for the Second Circuit that reversed the conviction of Alfred Caronia, a drug representative accused of conspiring to promote the drug Xyrem for unapproved uses set up a clash between the industry and federal regulators.

This week, in the New England Journal of Medicine, two researchers have called on the U.S. Food and Drug Administration (FDA) to stand firm against so-called off-label promotion of drugs and reject the legal precedent set in the Caronia case, the Regulatory Affairs Professionals Society (RAPS) reports.

Researchers Call for FDA to Retain Industry Oversight

University of Arizona law professor, Christopher Robertson, and Harvard University professor of medicine, Aaron Kesselheim, argue that the court’s decision in Caronia “subverted decades of presumptions about how the government could oversee the behavior of the pharmaceutical and medical device industries.” The attorneys at Parker Waichman LLP have assisted many people who allege they suffered injuries and side effects due to off-label use of a drug or medical device.

Xyrem (sodium oxybate), the drug in the Caronia case, received Food and Drug Administration (FDA) approval for treating narcolepsy, but Caronia promoted it for a range of other—unapproved—uses including insomnia, Parkinson’s disease, and fibromyalgia, Robertson and Kesselheim write. They explain that off-label use is common, especially in specialties such as oncology. But the authors say the off-label uses Caronia proposed were not based on high-quality data and were likely to cause patients substantial harm (sodium oxybate is also known as the “date-rape drug”).

At trial, prosecutors used Caronia’s own words to show that in speaking with doctors, he intended the drug to be used for nonapproved purposes, in violation of the Food, Drug, and Cosmetic Act (FDCA). The appeals court reversed the conviction, holding that Caronia’s sales pitches were protected commercial speech under the First Amendment.

Drug Companies Seek Wider Latitude in Promotion

Under current restrictions, drug companies may not advertise or promote off-label uses for drugs, but doctors are free to prescribe a drug for any use the doctor thinks is beneficial for the patient. The Caronia case raises the issue of whether drug companies can communicate with health care providers about uses that have not been given FDA approval. The industry argues that the First Amendment gives them the right to share information about drugs with doctors as long as the information is “truthful and non-misleading.”

Those in favor of retaining off-label restrictions say restrictions are necessary to protect the public from medications or devices that have not been shown to be safe and effective.  But the drug industry argues that First Amendment protections should allow the company to share “truthful” information.

Industry observers worry that if other federal courts, or even the Supreme Court, adopt the holdings in Caronia, this could adversely affect the health care system. A manufacturer could obtain narrow FDA approval of a drug or device and then promote the product for additional uses based on inadequately controlled observational “real-world” evidence, according to Robertson and Kesselheim. In recent years, the U.S. Supreme Court has expanded the conception of what counts as “speech” and has generally increased legal protections for speech. In a 2011 case, for example, the court held that protected speech included sales data used by pharmaceutical manufacturers.

Robertson and Kesselheim argue that the Caronia decision undermined decades of presumptions about how the government could oversee the behavior of the pharmaceutical and medical device industries. For more than 50 years, the FDCA has required that drugs and high-risk devices be labeled for intended uses that have been demonstrated in clinical trials. The FDA created a provision to allow companies to distribute peer-reviewed literature or answer physician questions. But until the Caronia decision, if a company promoted uses that had not received FDA approval, such promotion would be clear evidence that the product was misbranded and sale for those uses was illegal.

Clash Over “Off-Label” Promotion of Drugs and Devices

Clash Over “Off-Label” Promotion of Drugs and Devices

Congress established the FDA’s premarketing approval process “to channel claims about safety and efficacy into an expert agency, where the claims can be evaluated rigorously and independently on the basis of submitted evidence,” according to the New England Journal of Medicine.

But the drug industry seeks to roll back FDA regulations.  In recently proposed guidelines for off-label promotion, industry members say they should be allowed to “responsibly” promote new uses to physicians. The FDA is undertaking a comprehensive review of its rules about off-label promotion and next week will hold a two-day public hearing on off-label communications.

Kesselheim and Robertson say Constitutional rights should not be used “to undermine the primary functions of federal regulation . . . to protect patients and to create a high-quality market for drugs and devices” based on science rather than hype.

Help for Victims of Off-Label Side Effects

If you or someone you know has suffered an injury or side effect that may be linked to off-label drug or device use, contact the experience attorneys at Parker Waichman LLP. The firm offers free, no-obligation case evaluations. Contact Parker Waichman by filling out the online form or calling 1-800-YOURLAWYER (1-800-968-7529).

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