Sunday, December 30, 2012

Did off-label promotion just become legal?

To read a blog on this issue, click here


Kenneth Woliner MD said...

If one looks at the history of drug regulation in the United States, from even before the Pure Food And Drug Act of 1906, you would see how scary it is without active regulation of this industry. Patent remedies often had opium and other addictive narcotics in them, but were not labeled as such.

Moving forward, each amendment to this law (which is now called the Federal Food, Drug, and Cosmetic Act) had a purpose, that is to protect consumers by allowing medicines to be sold only if they were proved SAFE AND EFFECTIVE FOR THE PURPOSE ADVERTISED. Being "safe" enough to be sold is not enough, a drug also has to be "effective", otherwise potent marketing could convince doctors and patients to use an ineffective drug (when an effective therapy already exists), thereby hurting the patient by delaying/denying medical care that has been proven effective.

This decision regarding the off-label promotion of Xyrem (which contains the same active ingredient as GHB, a date-rape drug) is troubling to me. Ironically, I do prescribe Xyrem for both FDA-approved uses (narcolepsy), but have also prescribed it for unapproved uses such as "alpha-wave intrusion", a sleep disorder seen in Fibromyalgia and Chronic Fatigue Syndrome. Although I believe a physician should be able to prescribe "off-label", I have deep reservations about how off-label promotion to physicians (who are not as savvy as we may think), would cause them to prescribe inappropriately. If you recall, it was the shady marketing of OxyContin as "not addictive, not likely to be abused" that led to ten years of "Pain Clinic Pill Mills" here in South Florida.

Free speech is important, but "misleading commercial speech is entitled to no first amendment protection." (quote is attributed to Victor Herbert, MD, JD and his article "Legal aspects of specious dietary claims."). The com ined effect of this court case, as well as "Thompson vs Western States" (that struck the entire section on Compounding Pharmacies out of the FFDCA due to free speech reasons) has made consumers less safe. I only hope that the Supreme Court will clarify, or Congress will re-write laws, to ensure patients are protected against "misleading speech", I.e. Off-label promotion of drugs that haven't been proved safe and effective for the purpose they are being advertised.

Doletta Sue Tuck said...

Thank you Dr. Woliner for your informative comments. Very helpful to the readers.

Kenneth Woliner, MD said...

You are very welcome. And thank you for keeping up with this blog. I find it all so fascinating.

Here is that reference from Dr Victor Herbert, M.D., J.D. (full text is available to read free):

Bull N Y Acad Med. 1982 Apr;58(3):242-53.
Legal aspects of specious dietary claims.
Herbert V.
PMID: 6956409 [PubMed - indexed for MEDLINE] PMCID: PMC1805329 Free PMC Article

Ken Woliner, MD said...


A better reference for my argument about misleading commercial speech can be found here:

Commercial speech has been defined by the Supreme Court as speech where the speaker is more likely to be engaged in commerce, where the intended audience is commercial or actual or potential consumers, and where the content of the message is commercial in character.

Commercial speech, such as advertisments, has been ruled by the Supreme Court to be entitled to less protection under the First Amendment than noncommerical speech. Under the First Amendment, noncommercial speech is entitled to full protection, and any sort of content-based regulation is only valid if it can withstand strict scrutiny. However, noncommerical speech is not given such deference. For a content-based regulation of commercial speech to be valid, it only must withstand intermediate scrutiny.

Additionally, commercial speech that is false or misleading is not entitled to any protection under the First Amendment, and therefore can be prohibited entirely.