FDA plans to ease rules for reprinting off-label use info
■ The proposal would allow greater use of journal articles about off-label use of drugs and devices.
By Susan J. Landers — Posted March 17, 2008
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Washington -- Drug firms would have a more direct route to physicians when it comes to spreading the word about new research findings for off-label uses of drugs and devices, if a new Food and Drug Administration proposal is finalized.
The proposal, which was published in the Feb. 20 Federal Register, would allow pharmaceutical manufacturers to distribute reprints of journal articles that support a particular use of a drug or device that does not appear on its label.
The FDA's action would reinstate an earlier policy allowing the distribution of such information. But this time around, less agency oversight would be required in the process, and that change has sparked concern. Specifically, it would not require the agency to preview the material that is to be sent to physicians, nor does it require pharmaceutical companies to submit applications to gain approval for the new indication.
Meanwhile, the FDA also published a lengthy draft guidance for the pharmaceutical industry explaining "Good Reprint Practices." Among the requirements: Only reprints from peer-reviewed journals that have editorial boards staffed by experts would be allowed, and false or misleading information would not be allowed.
Off-label use of drugs and devices is a common practice in physicians' offices. A 2006 study in the Archives of Internal Medicine found that unapproved uses accounted for 21% of an estimated 725 million scripts written in 2001 for 160 frequently prescribed drugs. Given the continued growth of prescription medicines, those numbers likely have increased.
The researchers also found that many off-label uses lacked scientific evidence for the indication they were being used to treat.
But the FDA saw potential value in disseminating published articles promoting such uses. "Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, PhD, FDA deputy commissioner for policy, in a statement announcing the proposal.
Industry representatives echoed that position.
"The information contained in peer-reviewed medical journal articles can offer physicians valuable insight that helps them make informed decisions regarding appropriate medical treatments for their patients," said a statement from Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America.
"For a wide range of patients, pharmaceuticals that their physicians prescribe off-label constitute the medically recognized standard of care, such as for patients who suffer from serious conditions like cancer."
The FDA is accepting written comments on the proposal until April 21.
The American Medical Association is reviewing the proposal and may comment. AMA policy strongly supports physicians' autonomous decision-making, including their use of an FDA-approved drug or medical device for an unlabeled indication when sound scientific evidence and medical opinion supports such use.
The Association also has policy stating that physicians need access to accurate and unbiased information about off-label drug uses.
Where's the evidence?
But several early readers of the proposal have raised concerns.
"In a way, [the proposal] opens a can of worms," said David Radley, MPH, lead author of the Archives study on off-label drug use and a PhD candidate at Dartmouth Medical School in Hanover, N.H.
"Without being able to monitor the information being given to prescribers, you are essentially endorsing the promotion of drugs for uses that are still not that well understood," he said.
"In the paper, we found there was not a lot of evidence for some of the common off-label uses. That probably hasn't changed very much," Radley added.
On the other hand, while drug companies have an incentive to sell their products, they don't have an incentive to promote uses that are going to make patients sick, Radley said. "So they have a pretty good sense of what they think they can safely promote as an off-label use."
Others viewed the plan as a step back from a 1997 law, which expired in 2006, requiring companies to submit medical journal articles in advance to the FDA and agree to file within certain time frames for approval of the new uses.
"If [the drug or device] doesn't meet that standard, then they should not be out there sharing information with physicians," said Susan Wood, PhD, research professor at George Washington University's School of Public Health and Health Services in Washington, D.C.
Dr. Wood was director of the FDA's Office on Women's Health until she resigned in 2005 over what she saw as unnecessary agency delays in approving over-the-counter sales of the contraceptive known as Plan B.
Similarly, the proposal prompted Rep. Henry Waxman (D, Calif.) to charge in a letter to FDA Commissioner Andrew von Eschenbach, MD, that the document would shield drug companies from any responsibility. It also would "undermine the law requiring the companies to seek approval [of the reprint] before marketing a drug or device," Waxman wrote.