A new court ruling focusing on the off-label promotion of prescription drugs may change the future of the pharmaceutical industry.
In the case, members of a three-judge panel at the Court of Appeals for the Second Circuit in Manhattan wrote that the defendant, drug salesman Alfred Caronia, "promoted the drug Xyrem for 'off-label use', that is, for a purpose not approved by the U.S. Food and Drug Administration."
Caronia was convicted, but upon appeal, argued that "he was convicted for his speech – for promoting an FDA-approved drug for off-label use – in violation of his right of free speech under the First Amendment." That defense worked – the appeals court agreed with him on Tuesday, and in doing so, perhaps set the stage for a radical shift in how the pharmaceutical industry markets its products:
What if it no longer had to fear retribution for advertising drugs for purposes beyond what the FDA has approved?
To be clear, doctors can prescribe off-label, because the FDA doesn't have the legal authority to regulate the practice of medicine. But marketers cannot currently promote a drug for anything other than what the FDA has approved.
How far-reaching the effects of this ruling are will depend on whether it reaches the Supreme Court; if it does, though, and if it's upheld, the implications would be major – not just for the pharmaceutical and health care industry, but perhaps also for trends in prescription drug misuse. Lt. John King with the LAPD's Gang and Narcotics Division doesn't like the idea of drug companies being able to promote off-label uses of their products.
"Anytime you deviate from what the FDA indicates is safe and proper use of a pharmaceutical drug, you run the risk of problems," he said. "And we already have enough of a prescription drug problem in America as it is. We don't need to add to that."
King isn't the only one worried. While the Pharmaceutical and Researcher Manufacturers of America said in a statement that it "believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients," at least one other doctor said it's bad for public health.
"This is going to get much worse," New York psychiatrist Dr. Andrew Kolodny told ABCNews.com. "It's a safe bet that health outcomes will decline from medication side effects, while spending on prescription drugs will continue to rise."
Area police have noted that prescription drug abuse is becoming more prevalent in South Los Angeles.
Photo by Eric P via Flickr Creative Commons.