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Study Says Off-Label Use Should Be Restricted

Oct 30, 2008 | Parker Waichman LLP Researchers are asking for stricter penalties and fines for those pharmaceutical companies that market drugs for "off label" promotion.  According to both Adriane Fugh-Berman, M.D., an associate professor in the GUMC Department of Physiology and Biophysics, and Douglas Melnick, M.D., a preventive medicine physician in the Los Angeles County Department of Public Health, new regulations are needed to address this practice.

Both researchers have extensive experience in the pharmaceutical industry, with Melnick having worked as a physician in industry medical affairs, which supported pharmaceutical marketing efforts and Fugh-Berman as the principal investigator of PharmedOut, a project to educate physicians about the influence that pharmaceutical companies have on drug prescribing.  The two argue that, "states and other jurisdictions have a duty to protect the health of the public.  Allowing off-label promotion of drugs for untested, unproven benefits maximizes industry profits at the expense of public health."  While physicians can prescribe medications off-label—or for purposes other than those approved by the Food and Drug Administration (FDA)—pharmaceutical companies are legally restricted from marketing drugs for nonFDA-approved uses.  Despite this, off-label marketing is quite extensive.

The study details the ways in which the pharmaceutical industry uses marketing to encourage "the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown."  The study also points out that, "While off-label use is sometimes necessary… valuable off-label uses should be discussed by unbiased researchers in bona fide medical journals.  Promising therapies should be tested in clinical trials.  Truly useful off-label benefits of drugs will not remain a secret."

When a drug is approved for at least one indication, it may legally be prescribed off-label for a different condition, population, or dose than for what it was approved.  The study points out that such uses have not been tested and reviewed as required as a precondition for marketing approval.  The benefit is unknown for most off-label uses because the drugs have not been studied for those conditions, the authors state.

Although off-label marketing is illegal, the authors not that industry encourages these uses.  For instance, manufacturers seek federal approval for a narrow use of a new drug so that drug can be rushed to market in anticipation of its extensive off-label use. "In other words, a drug may be approved for a decoy indication while an extensive off-label campaign is not disclosed to regulators," the authors say.  Once approved in this way, labeled and off-label promotion may occur concurrently through journal advertising, direct mail, publication of "case studies," presentation of posters, abstracts at scientific meetings, and through "word-of-mouth" or "buzz" marketing by nationally known, influential academic physicians.  The researchers note that such marketing has made the distinction of off-label uses hazy while encouraging the unmonitored and often dangerous use of drugs by patients for whom risks and benefits are unknown.  The authors suggest restrictions to off-label promotion of drugs should be strengthened and that "companies that engage in off-label promotion should be heavily fined, and their future marketing practices subject to increased scrutiny by regulatory agencies."

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