Healthy Skepticism Library item: 12860
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Perrone M.
FDA to guide off-label drug marketing
BusinessWeek 2008 Feb 15
http://www.businessweek.com/ap/financialnews/D8UR0T880.htm
Full text:
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.
Since the expiration, companies have continued the practice, but questioned its legality.
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.
But companies that directly encourage such use can end up in legal hot water. Over the last decade, federal prosecutors have targeted companies including Pfizer Inc., AstraZeneca Pharmaceuticals, and Eli Lilly & Co. for off-label marketing.
Under FDA’s proposal, posted online Friday, the agency says it will not punish companies for distributing literature on off-label uses if they adhere to certain practices.
Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating FDA has not reviewed them.
Drug industry advocates said the proposal firmly establishes FDA’s role as a regulator of medicine — not information.
“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.
Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the article’s accuracy could be reviewed. Under the new proposal, drug companies don’t have to submit articles to the FDA.
Lawmakers worry companies will over promote potentially dangerous uses.
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.
FDA still has time to revise the rules. According to its Web site, the agency will accept comments on the proposal for two months before writing final guidelines.
