Endo Health Solutions and its subsidiary Endo Pharmaceuticals, based in Malvern, Pennsylvania, have agreed to pay $192.7 million to resolve criminal and civil allegations that it misbranded and promoted the use of an adhesive pain patch, Lidoderm, in ways that the Food and Drug Administration had not approved.
“The big takeaway is be careful how you market your drugs. Endo got slapped pretty hard,” said Andrew Peterson, a professor clinical pharmacy and health policy at the University of the Sciences.
Companies can provide off-label information to doctors, but only if they ask for it, Peterson said
The settlement covers actions taken from the late ’90s to the late 2000s. The FDA had approved Endo’s Lidoderm patch for alleviating pain from shingles complications. Federal agencies including the U.S. Department of Justice charged that Endo had promoted the drug for conditions such as carpel tunnel, diabetes and lower back pain, through misbranding and direct sales pitches to doctors. The case involved whistle-blowers.
“Our concern in off-label marketing cases is that it undermines the doctor-patient relationship, and it adversely influences the medical judgment that doctors exercise in treating their patients,” said Mary Catherine Frye, a lawyer with the U.S. Attorney’s office in Philadelphia who was involved in the case.
Frye alleged federal health programs including Medicare were in turn wrongly billed to cover Lidoderm for off-label uses. The settlement money, she said, will reimburse the federal and state programs and, in turn, taxpayers.
In a statement, Endo’s president Rajiv De Silva said the company “takes its responsibility to patients, health care providers and our shareholders very seriously,” adding it’s confident it has “the robust programs in place to assist us in satisfying our legal and regulatory agreements. We are committed to a company culture that supports the conduct of our business in a compliant and ethical manner.”
As part of the civil settlement and deferred prosecution agreement, Endo has agreed to additional compliance measures.
Off-label marketing has increasingly caught the attention of the U.S. Attorney’s Eastern District of Pennsylvania’s office. Lawyers there have handled several other cases in recent years; in November, Johnson & Johnson agreed to pay more than $2 billion to settle charges of improperly marketing an antipsychotic drug.
‘Fuzzy legal area’
But rules around off-label promotion aren’t so clear cut and may fall in a “fuzzy legal area,” according to Robert Field, professor of law and public health at Drexel University.
FDA has guidelines on what companies can and can’t let doctors know about drug uses not yet vetted by the FDA, said Field. But some rules are being challenged in court.
“On the one hand, you don’t want companies promoting a drug for uses that the FDA has not had a chance to evaluate. It may turn out the drug doesn’t work for those uses, or is dangerous for those uses,” he said. “On the other hand, we know that drugs are more valuable than just what the FDA has reviewed. So you want doctors to know something about that full range of uses.”
Most civil and criminal cases to date have involved direct examples of when a drug became potentially harmful to a patient or when there was “out-and-out fraud for a use [of a drug] that clearly doesn’t work,” Field said.
Endo’s case, he said, doesn’t appear to go that far.
This disclosure, Endo supports WHYY.