In last Wednesday’s issue of the New York Times, an article titled “Botox Maker’s Suit Cites Free Speech” reported about a controversy that has arisen regarding drug marketing regulations. According to current Food and Drug Administration (FDA) regulations, drugs may only be marketed for the specific uses that the FDA has approved them for. However, while they cannot be marketed for other uses, doctors are allowed to use their “medical judgment” to prescribe drugs for other uses that have not been officially approved.
Botox makers would like to be able to market their product for uses other than treatment of crosses eyes, eye spasms, severe neck contortions and wrinkles, the only FDA approved uses. Currently, Botox is often prescribed by doctors for use in treating facial spasms, vocal cord problems, and migraines, but these are not FDA approved and thus cannot be used in marketing. Allergan, the Botox company that is suing the FDA for infringement of its freedom of speech, would like to be able to market Botox for these as yet not approved uses as well.
Two pieces of information brought up in this article disturbed me. First, I was not aware that doctors were allowed to prescribe drugs for uses that are not FDA approved (or approved by any official body at all). Although doctors do usually act under the Hippocratic Oath, and thus are unlikely to prescribe a treatment that will undoubtedly do the patient harm, the fact that doctors have this much flexibility does seem to open the door wide for unregulated and potentially risky experimentation. In addition, because drug companies cannot market off-label uses of drugs that doctors may prescribe to patients, doctors may not always have all of the relevant information that the drug companies have regarding the risks of the use of drugs for different purposes. In short, drug companies are banned from providing information regarding techniques (including correct doses) and risks in the use of the drugs for off-label treatments leading to a system of guess-and-check by medical professionals.
There are two methods by which this second issue of lack of information to doctors could be solved. First, drug companies could be allowed to market their drugs for off-label, non-FDA approved uses. This does not seem to be the best option as it could potentially lead to hazardous experimentation in the medical field. The second option would be to only allow doctors to prescribe drugs for FDA approved uses. This seems ideal. However, the FDA would have to work overtime to research the risks and benefits of each drug for each type of treatment that is proposed so as to not inhibit medical advancement by being slow to improve beneficial treatments.
Related links:
http://www.nytimes.com/2009/10/03/business/media/03drug.html?scp=2&sq=botox&st=cse
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2 comments:
When I was reading your blog entry, a few things you said caught my attention. You were concerned that doctors could prescribe a drug for a condition that did not fall under its list of approved uses by the FDA (a.k.a off-label uses). You also mentioned your concern that these wide-open choices would lead to “potentially risky experimentation.” I do not agree with this opinion. Approved labeling is done to allow the consumer or physician to decide if what they are taking is safe and effective. If a drug had not been tested for the safety in a specific category Z, then the label would say that the safety of the drug has not yet been approved for “Z.” The labels are meant to be used as a “heads up” to guide doctors in their choices of prescription. The doctors then have the information to decide if it is the correct drug for the patient. The lack of approval by the FDA for a given use does not necessarily mean it has a high risk to benefit ratio, or that negative experimentation will occur. As long as the doctor is following the “do no harm” philosophy, there will not be a conflict.
Aside from your concern regarding off-label uses of drugs by doctors, you also had possible solutions for how to deal with the lack of information doctors are given. The first solution you posed for marketing drugs for off-label uses would not be a practical idea. It would be illegal to market a drug use that has not yet been tested for its safety, etc. It is one thing for a doctor to choose to use the drug, but another to market its use to the public. The second solution you posed was to only prescribe drugs for their given FDA uses. This would create problems with any type of relatively rare disease. A drug may need to be given, but one may not exist. Drug companies are not going to spend the time and money to test drugs for a disease that will be needed by only a small number of patients. The amount of money it costs to do the testing in order to meet Investigational New Drug regulations would be more than the company could recover from selling the actual drug. A doctor would most likely choose another drug used for a different disease if he could not find the correct drug with FDA approved usage. It is important to be able to use drugs off-label because this could lead to discovering new approved uses. As Robert J. Meyer, from the FDA Center for Drug Evaluation and Research, said: “it is important to note that FDA recognizes that some important approved uses of drugs have come about as a result of clinical use initially occurring off-label, with subsequent adequate and well-controlled trials documenting the safety and efficacy of these uses and thereby being placed into approved labeling.”
References:
http://www.thoracic.org/sections/chapters/thoracic-society-chapters/ca/current-news/resources/Off-label%20Rx.pdf
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