FDA to Guide Off-Label Drug Marketing
By MATTHEW PERRONE AP Business Writer
Â© 2008 The Associated Press
WASHINGTON â€” The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.
The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.
Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.
Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.
Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.
"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.
But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.
Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.
Hereâ€™s a link to the FDA statement:
And hereâ€™s a link to the complete AP story:
Knowledge is power. And information saves lives.