The US Food and Drug Administration has announced that there will soon be a public meeting to explore providing drug companies with greater flexibility in promoting off-label indications to doctors. When it comes to prescribing medications to children, and particularly psychiatric medications, this is a bad idea.
I write both as a former consultant to the pharmaceutical industry, and as a father who lost a son to the toxic effects of antipsychotics prescribed off-label.
Prescribing off-label currently means that the doctors can prescribe drugs to patients for treatment even though there is no formal FDA approval based on efficacy and safety studies for the therapy areas involved. Rather, it is expected that the doctor closely monitor the patient to review safety and efficacy over time. To be clear, the FDA does not have the legal authority to regulate the practice of the medicine. However, they do have the right to regulate the marketing and promotion of a drug. It is now illegal for drug companies to promote off-label indications to doctors.
The are two drivers for this FDA initiative: the desires of the drug companies to be able to say more to the doctor—albeit based on softer data—in order to expand the use of the products; and two recent court decisions (US v Coronia, Amarin v. FDA) where the judges considered hampering the ability of the sales reps to speak freely to the doctors to be a violation of their first amendments rights to free speech.
This FDA meeting is a good idea. Off-label prescribing definitely needs to be better thought out.
One flaw in the current system needs to be addressed urgently: All therapeutic areas are not the same. Off-label may work well in cancer, but can do real harm to children, especially in the area of children’s mental health. As a nationally known healthcare consultant with over thirty years’ experience in this industry, I thought I knew and trusted our healthcare system; until my only son died from off-label prescribing of excessive amounts of the atypical antipsychotic drug Seroquel. My son was a bit lethargic on a Friday night, but was in an irreversible coma on Sunday morning, ultimately passing away from a side effect called neuroleptic malignant syndrome.
Children are already the least-protected citizens under the eyes of the FDA. Every adult has the benefit of FDA-approved labeling that has been created after rigorous clinical tests. Every doctor has “best practices” guidelines on how to prescribe to adults. Every pharmacist has software to guide prescribing and point out possible drug interactions in adults. None of these exist for children’s medications. This is all due to the lack of data on medication effects in children. Moreover, while insurance companies carefully monitor doctors’ prescribing to insure efficacy and cost-effectiveness in medications for adults, there is virtually no analysis of effective prescribing to children. Relaxing off-label prescribing in children’s medications will increase the risk to children dramatically.
I have just completed a book—actually a dramatic case study covering eight years of off-label prescribing in children’s mental health—based upon my role as a father, a healthcare consultant, and extensive reading and writing as well as a malpractice lawsuit following my son’s death. I am now an expert with a 360-degree understanding of the weaknesses of off-label prescribing to children for mental health reasons. I have serious criticisms and recommendations for the physicians, drug and insurance companies, schools and parents.
In the United States today over $20 billion of psychotropic drugs are prescribed to five- to eighteen-year-olds in the mental health category. It is estimated that more than 95% of these drugs are prescribed off-label. Currently, over 12 million children are taking psychotropic drugs in the US annually. One CDC study found that in a given month 6% of adolescents in the U.S. reported taking psychotropics.
The drug companies have been fined over $12 billion in the last nine years for the illegal promotion of these drugs to children. Just last month another case was filed involving the illegal promotion of Abilify for children. That means that the playing field is already—de facto—very extensive. Fines mean little and the FDA rules are clearly not an inhibition to the expansion of off- label business. We should all look at the children’s mental health area as a real-life example of what to avoid in off-label prescribing.
Rather than relax off-label prescribing, we should first tighten up the rules for medications prescribed to children. We need more data, guidelines and probably regulations. Our children need more protection, not less. Second, all indications are not the same. The children’s mental health sector has been turned into a vast medication minefield for the children and their parents. The typical medications for children diagnosed with ADHD, bipolar, depression and anxiety have been challenged on their scientific validity. Many are only too late, given the black-box warnings due to their risk to children. Atypical antipsychotics should be the next black-boxed drug.
Greater flexibility for drug companies’ promotional opportunities is the opposite of what we want and need for our children. Let’s use this FDA meeting to move regulation of off-label promotion into the 21st century, and thereby reduce the risk in children’s prescribed medications.
