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You can say what you want to say about the FDA and how effective it is in protecting Americans from dangerous foods and drugs. But the simple fact is: the FDA requires a certain level of responsibility and accountability on the part of the food and drug manufacturers and distributors themselves. When a food or drug manufacturer or distributor complies with the FDA’s rules, such as by submitting to the FDA all studies and safety tests it has conducted or gathered, not just the ones that make its products look good, then Americans are better protected from dangerous foods and drugs. But when a food or drug manufacturer does not comply, or, even worse, when it breaks the rules… well, our safety becomes seriously jeopardized.
Here is a rule, called an implementation regulation, that the FDA has regarding pharmaceutical drugs:
This FDA implementation regulation is also backed up by the Federal Food, Drug and Cosmetic Act (the FD&C).
It’s an important rule, one that can help ensure our safety when it is heeded. But when the rule is broken? Let’s look at the case of the antipsychotic drug Risperdal to find out.
Risperdal is an atypical antipsychotic drug mainly used to treat schizophrenia, schizoaffective disorder, the manic states of bipolar disorder and irritability in people with autism. However, and this is very common, Risperdal was never approved by the FDA in a “final sweep,” so to speak. Instead — and our safety from dangerous drugs depends on this step-by-step measure — Risperdal was approved on a treatment-by-treatment basis.
So while Risperdal received FDA approval for treatment of adult schizophrenia in 1993, it was only approved for the treatment of adolescents with schizophrenia in 2007. Likewise, while Risperdal was approved for the treatment of adult bipolar disorder in 2003, it was only approved for the treatment of children with bipolar I disorder in 2007, while, in 2006, Risperdal was approved for the treatment of irritability in children ages five to 16 with autistic disorder.
That may be a lot of information to absorb, but a simple take-away for a patient and his or her family is this: Risperdal was not approved for use in children at all — for any purpose — until the end of 2006. And, even as of today, Risperdal is only approved for specific, limited uses in children and adolescents.
Unfortunately, Johnson & Johnson did not play by the rules, instead choosing to target doctors treating children and adolescents before the FDA had approved Risperdal for treatments within those age groups. To make matters worse, there is evidence that the FDA had repeatedly told Johnson & Johnson that its promotion of Risperdal for children was inappropriate and could be a violation of the law.
Let’s look back at that FDA implementation regulation again. Now, under the regulation, the FDA says that doctors may use a drug to treat patients for diseases or symptoms even when the drug is not approved by the FDA for such uses. This is called an “off-label” use, and it is okay for doctors to do — but it is not okay, on the other hand, for drug manufacturers and distributors to promote or target their drugs to doctors for off-label uses.
In fact, if a pharmaceutical manufacturer intends for its drugs to be used for a new use unapproved by the FDA, and introduces the drug onto the market to be sold for that use, then the FDA considers this misbranding and a violation of the law.
See where we’re heading with this as far as Risperdal is concerned?
FDA Commissioner Margaret A. Hamburg, M.D., was quoted saying that, “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications… The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective… pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”
So we’d say rules do matter. Wouldn’t you?
And for the record: “Peril” means lawsuits, ones that occur once patients learn that they have been harmed because the drug manufacturer they trusted did not play by the rules.