As Risperdal and Zofran Lawsuits Continue, Industry Urges FDA to Loosen Off-Label Marketing Rules

Published on November 14, 2016 by Sandy Liebhard

The pharmaceutical industry has urged U.S. health regulators to loosen rules that govern the off-label promotion of prescription drugs. These types of marketing practices are among the major issues of contention central to thousands of Risperdal lawsuits and Zofran birth defects claims now pending in courts around the U.S.

Off-Label Drug Marketing

Off-label prescribing is a fairly common- and perfectly legal – practice. For example, doctors have long prescribed Zofran as a treatment for pregnancy-related nausea and vomiting, even though the drug has never been approved for this purpose. Likewise, thousands of children were treated with Risperdal prior to 2006, when it was first approved for pediatric use by the U.S. Food & Drug Administration (FDA). However, pharmaceutical companies are forbidden from promoting off-label indications in the marketing and advertising materials for their products.

Last week, the FDA convened a two-day hearing to debate the agency’s rules on off-label marketing. Not surprisingly, drug makers believe the agency’s current regulations are too strict, going so far as to characterize the rules as “stifling,” “a limit to innovation” and a “violation of the First Amendment.” The industry is urging the FDA to allow drug reps to discuss scientific evidence and data regarding unapproved indications with physicians, a practice that is currently forbidden.

Patient advocates, however, argue that an easing of off-label promotion rules would place the public at risk. Among other things, they point to a 2015 JAMA Internal Medicine study that tied off-label prescribing to a 44% increased risk of adverse drug events.

“The FDA would be reckless to weaken rules and allow the pharmaceutical and medical device industry to promote products for which they are not proven to be safe and effective,” Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, said in a press release. “Opening the door to the promotion of potentially dangerous products undermines the entire FDA approval process. The FDA needs to slam this door shut.”

Drug Companies Penalized for Off-Label Promotion

In November 2013, the U.S. Department of Justice (DOJ) announced that Johnson & Johnson and its Janssen Pharmaceuticals unit had agreed to pay $2.2 billion to settle charges that they improperly marketed Risperdal and other medications. Under the terms of the settlement, the companies pled guilty to illegally promoting Risperdal for off-label use in elderly dementia patients. However, they did not admit wrongdoing in resolving allegations pertaining to the off-label marketing of Risperdal for children.

A year earlier, the DOJ settled similar charges with GlaxoSmithKline for $3 billion. Among other things, the company was accused of improperly promoting Zofran as a morning sickness remedy, even though it has never been proven safe or effective in treating pregnancy-related nausea and vomiting.