April 8th, 2011
Drugmakers Hooked On Shady Promotion
One way a drug company can increase sales is by promoting medicines for purposes that haven’t been approved by the Food and Drug Administration. The practice, called off-label marketing, is illegal. But, as a slew of settlements with the government have shown, it’s been commonplace.
How common? Just ask Dr. Aaron Kesselheim, a doctor at Brigham and Women’s Hospital in Boston. He has pored over dozens of complaints from whistle-blowers and compiled a comprehensive picture of off-label marketing practices. And his findings appear in the latest PLoS Medicine.
We caught up with Kesselheim, who tells Shots that some of the most common problems, including companies ambitious sales quotas for reps, are also the hardest to regulate.
The details in his analysis won’t shock anyone familiar with the industry. Off-label marketing has become ubiquitous and persistent. Take a look at Pfizer, for instance. In 2004, Pfizer was taken to court over off-label promotion of an epilepsy drug called Neurontin, and promised to change its practices. Years later it was revealed that at the exact same time, it was pushing unapproved uses of the painkiller Bextra, since withdrawn from the market.
“In the Neurontin case, the ultimate settlement was 450 million dollars, whereas the sales of that drug were over a billion dollars in just one year,” Kesselheim says. “In general, these payments are a drop in the bucket — there is a concern that they are seen as the cost of doing business.”
So what will it take to curb off-label marketing? “It takes the industry’s willingness to change, and it also takes regulation and better attention by the FDA,” Kesselheim says.