Product News and Recalls

Bristol-Myers Squibb Settles Off-Label Marketing Suit

abilify maker settles off-label marketing lawsuitOne of the least-known facts in medicine is the amount of leeway a doctor has when it comes to prescribing medicine. They are essentially on their own; the final authority in determining the drugs their patients will take while under their care. So, while the FDA may have approved a drug to treat X condition, biology dictates that it might also have a positive effect on Y condition, and your doctor is well within his or her rights to prescribe for X or Y.

It is this leeway that has led to a boom in what is known as off-label marketing or off-label promotion. While a doctor has the final say in what drugs he or she will prescribe, the drug companies themselves are limited by the federal government in how they can market those drugs. Under normal circumstances, a drug can only be marketed as a solution to those things that the FDA has approved its use in treating. No information about tangential uses can be given to try to increase sales.

As one would expect, this is a huge point of contention, with vocal proponents and opponents on both sides. And, in some cases, drug companies are fighting these rules and winning. A prime example comes from a 2015 case in which Amarin Pharmaceuticals successfully used the First Amendment to argue that off-label marketing regulations curtailed the corporation’s right to free speech. Just over one year prior, Endo Health Solutions was ordered to pay $193 million for its off-label promotion of Lidoderm.

Present day, however, the battle over off-label drug promotion rages on as Bristol-Myers Squibb agreed to pay $19.5 million to settle claims that it was marketing Abilify, an anti-psychotic, for use in children and the elderly. These uses were not approved by the FDA when the marketing took place and, in fact, Abilify was given a black box warning in 2006 indicating an enhanced risk of death in elderly dementia patients.

As new drugs continue to be developed, they will undoubtedly affect us in ways that fall outside of the margins of why they were created. Biology is complicated, and affecting one system will almost inevitably influence another system. As such, the legal system, legislation, and politics will continue to steer what can and can’t be said in the closed-door meetings that likely determine what drugs you ultimately bring home from the pharmacy.