From
The Wall Street Journal:
U.S. government fines have made big drug makers "more sensitive than we've ever been" about preventing illegal promotion of their drugs, the chief executive of AstraZeneca PLC said in an interview.
AstraZeneca in September reached a preliminary agreement to pay $520 million to settle a U.S. investigation into its marketing of the schizophrenia drug
Seroquel, including allegations that the company promoted the drug for uses for which it isn't approved by the Food and Drug Administration. This practice, called "off-label marketing," is illegal.
AstraZeneca officials have declined to say whether the company will admit wrongdoing as part of the settlement, the terms of which are still under discussion. In an interview in London, chief executive David Brennan said: "We don't promote products off-label."
But he said off-label marketing has become "a much bigger issue in the last few years as a result of the government's position on this."
A number of drug companies, including Pfizer Inc. and Eli Lilly & Co., have reached large settlements in recent months with U.S. investigators probing marketing practices.
Doctors are free to prescribe drugs any way they see fit, but drug makers aren't allowed to promote them for unapproved uses.
Controversy has long dogged Seroquel. AstraZeneca is facing thousands of lawsuits filed by patients who allege that Seroquel caused them to develop health problems including diabetes.
Earlier this year, lawyers representing those plaintiffs released documents that they said showed that AstraZeneca executives discussed promoting the drug for unapproved uses. The documents cited plans to "broaden Seroquel use on and off-label," including among adolescents and patients with Parkinson's and Alzheimer's disease, at medical meetings, in sales calls and with patient-advocacy groups.