Tuesday, November 4, 2008

Calling for Off-Label Promotion Restrictions

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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, are two researchers asking for tougher more stringent regulation on off-label promotion of drugs. As it stands, once a drug has been approved for one condition, it can in some cases be legally prescribed for another condition or with different dosing. The two researchs, as mentioned here, believe 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." They further go on to say "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."

What is your viewpoint on this issue? Do you think there is a need for more stringent regulation with more penalties?
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