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When true enough is not good enough A recent court ruling that favored freedom of speech over the authority of the US Food and Drug Administration (FDA) to regulate off-label drug promotion may have profound implications for the way drugs are marketed and, ultimately, for patients’ interests. the off-label use of medications is exceedingly widespread The court found that, as long as the information that pharma
and accepted by the medical community. Physicians sales representatives give to doctors is true, the FDCA cannot can prescribe any approved drug for any condition they curtail their freedom of speech. The decision therefore changes
choose and discuss off-label use with their colleagues, and the burden of proof for prosecution of companies for misbrand-patients are certainly free to take drugs off label.
ing a drug in accordance with the FDCA. It will no longer be
In fact, virtually anyone who doesn’t work for the pharma- enough to spot off-label marketing to cry foul; instead, it will be
ceutical industry can advocate for the off-label use of a medi- necessary to show that the information presented is false. But, cine. Under the Food, Drug and Cosmetic Act (FDCA), which considering that there are essential y no clinical efficacy data for gives the FDA its regulatory authority, it is a crime to promote using Xyrem to treat Caronia’s broad list of diseases, the ruling
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a drug for purposes not listed in its label. In FDCA language, did not seem to take into account whether his statements were “introducing a misbranded drug into interstate commerce” is true or not. For the purpose of the decision, they seem to have illegal. GlaxoSmithKline’s $3 billion settlement last summer for been considered as true enough. promoting Avandia and other drugs for unapproved uses is a
The FDA is likely to appeal the decision, which may find
stern reminder that the FDCA means business.
its way to the US Supreme Court, where it will hopefully be
But on 3 December, a federal appeals court changed the reversed. But if it isn’t, and off-label promotion prevails, how
status quo by overturning the conviction of Alfred Caronia, a wil the validity of claims of drug efficacy by evaluated? To regu-sales representative for Orphan Medical, who promoted a drug late the promotion of over-the-counter products, the US gov-
for uses not approved by the FDA. The case involved the drug ernment uses the Federal Trade Commission (FTC) Act, which Xyrem, the active ingredient of which is g-hydroxybutryate, a also requires experimental evidence of efficacy before any claim compound federally classified as the ‘date rape drug’. Xyrem about the properties of a product can be stated to consumers.
is prescribed for certain types of narcolepsy, but Caronia was But it is easy to see from the countless ‘dietary supplements’ in caught promoting the drug for patients with conditions as the market that the burden of proof for the FTC is very different diverse as fibromyalgia, restless legs syndrome, chronic pain from the current drug-approval system enforced by the FDA. and Parkinson’s disease.
All parties—government, companies, physicians and
In a 2-to-1 decision, the judges stated that banning off-label patients—agree that off-label use of a drug has a legitimate
marketing violated the representative’s freedom of speech. place in the practice of medicine, provided it rests on truthful, This ruling is a mistake, as it upholds the freedom of speech of scientifically accurate information. The current system aims people with a vested interest in promoting a product without to balance between giving doctors the authority to prescribe considering the risk this represents for patients. By opening the drugs as they see fit and giving the FDA a clear-cut standard by door to off-label drug promotion by people with commercial which to keep the marketing departments of drug companies motivations, the court decision undermines the authority of the from running amok. Allowing companies to market drugs for FDA and the process whereby new drugs are approved. Indeed, unapproved uses will compromise the principle that drug effi-the dissenting judge, Judge Debra Ann Livingston, argued that cacy should be determined by rigorous clinical trial data and if pharma companies can promote FDA-approved drugs for will result in drugs being used inappropriately, which can harm nonapproved uses, “they would have little incentive to seek FDA patients. When it comes to patients’ interests, the government approval for those uses.” In other words, why bother with a and the pharma industry should not start playing games try-long and expensive clinical trial if one can just market a drug ing to agree on what reliable scientific data are, because ‘true without it?
enough’ is simply not good enough. nature medicine volume 19 | number 1 | january 2013
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