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FOR IMMEDIATE RELEASE: October 27, 2008


CONTACT:

Karen Mallet
414-312-7085
km463@georgetown.edu


Restrictions on Off-Label Marketing and Promotion of Drugs by Pharmaceutical Companies Should be Strengthened, Researchers Say


Washington, D.C. – Researchers are asking for tougher penalties and fines for pharmaceutical companies that market drugs for “off label” promotion, according to a study published in the October 28 issue of the open access journal PLoS Medicine.

New regulations are needed to address this practice, say 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. In the article, Fugh-Berman and Melnick address public health issues associated with off-label promotion and marketing.

Both authors have extensive experience with the pharmaceutical industry. Melnick once worked in as a physician in industry medical affairs, which supported pharmaceutical marketing efforts. Fugh-Berman is the principal investigator of PharmedOut, a publicly-funded project to educate physicians about the influence that pharmaceutical companies have on drug prescribing.

They 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.”

In their study, they detail the ways that the pharmaceutical industry uses marketing to encourage “the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown.”

The researchers are careful to point out that off-label use is sometimes necessary and is subject to a physicians’ best judgment.

“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.”

Marketing of off-label use of drugs is widespread
Once a drug is approved for at least one indication, it may legally be prescribed off-label for a different condition, a different population, or in a different dose than what the drug is approved for. However, off-label uses have not been subject to the testing and review that is a precondition for marketing approval, the authors say.

Off-label prescription of a drug is generally legal, and is sometimes unavoidable, especially because drugs are often not tested in children or in pregnant women. And while some off-label use is very beneficial, the authors say, benefit is unknown for most off-label uses because the drugs have not been studied for those conditions.
What is usually illegal, and what the authors highlight in their paper, is promotion of off-label uses by a drug manufacturer. But there are ways the industry encourages these uses anyway, the authors say. Among the strategies are:

Seeking federal approval for a narrow use of a new drug in order to speed a drug to market because a company anticipates 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 a drug is approved for a decoy indication, labeled and off-label promotion may occur concurrently through journal advertising, direct mail, publication of “case studies”, presentation of posters and abstracts at scientific meetings, and through “word-of-mouth” or “buzz” marketing by nationally known, influential academic physicians.
Pharmaceutical marketing has distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown, the researchers say.

They suggest that 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.”

PharmedOut is funded through the Attorney General Consumer and Prescriber Education grant program, created as part of a 2004 settlement between Warner-Lambert, a division of Pfizer, Inc., and the Attorneys General of 50 States and the District of Columbia, to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® (gabapentin) that violated state consumer protection laws. Fugh-Berman has been a paid expert witness on the plaintiff’s side in litigation regarding pharmaceutical marketing practices. Melnick reports no disclosures.
This study received no specific funding.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO), home to 60 percent of the university’s sponsored research funding.
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