April 22, 2008
Off-label promotion equals 19th Century medicine
Drs. Adriane Fugh-Berman and Douglas Melnick have written to the FDA:
"Loosening restrictions on the distribution of materials on off-label uses is an abdication of the FDA’s responsibility to protect the public. Off-label uses of pharmaceuticals have not been subject to the testing and review required for marketing approval. The scientific review of evidence of effectiveness and safety that drugs undergo prior to an approved, labeled indication for a drug protects patients. With off-label use, this protection does not exist.
While off-label use is sometimes necessary, it should be undertaken with the care and caution due the uncontrolled experiment to which a patient is being subjected. While some off-label uses are supported by randomized controlled trials, 73% of 150 million off-label prescriptions written in 2001 were for conditions that had little to no scientific support for efficacy.
Belief is an unreliable gauge of efficacy. In the 19th century, physicians believed that mercury, arsenic, and bloodletting were effective for common ailments. More recently, physicians believed that oxygen therapy benefited premature babies when instead it caused blindness , and that menopausal hormone therapy benefited women’s health when the opposite was true . In these and many other cases, randomized controlled trials trumped prevailing medical opinion with truth. While “medically-recognized standards of care” may exist outside of a product’s approved product labeling, it is inappropriate for the manufacturers to create or promote these off-label uses without conducting the studies and applying for the new indication with the agency.
Previously, although it was technically possible for pharmaceutical companies to distribute reprints regarding off-label uses, the FDA’s requirements were sufficiently stringent that companies generally avoided such distribution. FDA required an advance copy of any publications on off-label uses to be distributed, any information that the manufacturer had regarding effectiveness and safety of the new use, and a certification that the manufacturer was submitting a supplemental application for a new indication or reasons why a supplemental application was not being filed.
These safeguards have been jettisoned in the proposed guidance, part of which reads as if it were ghostwritten by industry. …
The 1962 Kefauver Amendment to the Food, Drug, and Cosmetic Act required efficacy of a drug before marketing. Allowing promotion for untested uses after marketing makes no sense. Let’s not turn back the clock to the 19th century, when physicians prescribed drugs with no evidence of efficacy.
Industry has much to gain, and the public health much to lose, by the implementation of this guidance. Restrictions on off-label promotion of drugs should be strengthened, not gutted. The FDA should not jettison its responsibilities to protect consumers."
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