Working off-label marketing cases opened my eyes to some really disgusting and frightening prescription writing practices. Off-label marketing is the practice of selling a drug for purposes for which it is not approved by the FDA. While off-label marketing of medication is often compared to the old time practice of selling “snake oil,” today’s version is far more dangerous. And no one is immune.
Off-Label Marketing is Dangerous
In my life before law, I did a lot of systems advocacy for people with cognitive disabilities. I noted odd things, like the “Diagnosis of the Month” and sudden whole program shifts to some new medication. Because I worked with people who were sometimes violent, I dreaded changes in medications because they impacted my clients negatively. People became more dangerous, or they wanted to sleep all day. At the time, I assumed the medication change was necessary. Now, I know those changes were likely the result of an off-label marketing campaign by a pharmaceutical company.
Civil Remedies Sometimes Don’t Work
In my previous law firm, I had the task of handling phone calls from the press that came after it was announced that the firm was involved in the $2.3 billion False Claims Act settlement against Pfizer. A major part of the case involved off-label marketing of prescription medication. The first few hours after the announcement were filled with calls and congratulations; by midafternoon, pundits were saying the settlement was too small because they predicted Pfizer’s conduct would not change. The settlement was viewed as a mere “cost of doing business.”
In the world of False Claims actions and the fight against government fraud, waste, and abuse, there’s been a push to criminally prosecute pharmaceutical company executives. False Claims acts can recapture millions, even billions, of misspent government dollars, but some larger pharmaceutical companies consider those huge payments to be merely a cost of doing business. I thought that Pfizer’s stock would take a serious fall when the settlement was announced, but no. The next day, Pfizer announced it acquired Wyeth, and stock prices increased.
Second Circuit – What Are You Doing!?!
On December 4, 2012, the Second Circuit dealt a serious blow to folks working to remedy off-label marketing when it ruled such conduct was protected commercial free speech. Commercial speech is limited by all sorts of considerations, not the least of which are health and safety. The Second Circuit is not the last word on the subject of course; the ruling could be appealed, and as long as it is not endorsed by the US Supreme Court, other Circuits could rule differently.
Rules on what people are allowed to do and not allowed to do change all the time. Don’t assume you can properly assess a False Claims act without the assistance of a properly qualified attorney.