The Food and Drug Administration (FDA) has some pretty clear rules, especially when it comes to when a pharmaceutical company can start marketing a drug. The rule is: You can’t market a drug until it has been approved by the FDA. Sounds pretty simple — and obvious, right?
Unfortunately, some pharmaceutical companies have a bad track record of not playing by the rules. The latest example of this is Janssen Pharmaceuticals, Inc. (JPI), a division of Johnson & Johnson that manufacturers and markets the drug Risperdal. Risperdal is used to treat adult schizophrenia, adult bipolar disorder and irritability in children five to 16 years old with autistic disorder.
Issue is, Janssen started marketing Risperdal to healthcare providers for use with children before the drug was approved to treat children or young adults, in any manner. Way before they were permitted to by the FDA, Janssen started to target doctors treating children, the implication being “this drug is safe and effective for the treatment of children and young adults.” Only it wasn’t.
Instead, boys taking Risperdal may find that they develop breast tissue, an unfortunate side effect of taking Risperdal. What’s more, this breast tissue may only be removed via surgery — it will not go away even when the patient stops taking Risperdal.
When Janssen started targeting doctors treating children, they took advantage of the system of trust established by the FDA.
Here’s why: Because of the FDA’s rules, doctors and patients alike trust that a drug is marketed because it is considered safe and effective for the group for which it is being marketed.
And yet, Risperdal was not safe for the young boys and men who were being targeted by Janssen Pharmaceuticals’ marketing and drug reps. Instead, Janssen took advantage of our faith in the system, and in turn hurt many boys and young men around the country because of its actions.
This is not the first time Janssen Pharmaceuticals broke our trust. In fact, Janssen has already been criminally fined $400 million for misbranding Risperdal, marketing the drug for use in the elderly when it was not approved for such purposes. This was something the U.S. Department of Justice took very seriously. At the time, Janssen made a guilty plea agreement. But, for whatever reason, it doesn’t seem as if they’ve learned their lesson.
Instead, history is repeating itself. But this time it’s not just the elderly who have been hurt, it’s also the next generation of men.
Janssen may think they can get away with it, but we think differently.