Off-label prescribing might get boost from FDA

April 1, 2008

Using drugs for conditions other than what's on the label is not new, but it may receive more encouragement if draft guidance from the Food & Drug Administration (FDA) is approved. Allowing more off-label use might also increase payers' pharmacy costs.

USING DRUGS FOR CONDITIONS other than what's on the label is not new, but it may receive more encouragement if draft guidance from the Food & Drug Administration (FDA) is approved. Allowing more off-label use might also increase payers' pharmacy costs.

The FDA is leaning toward allowing drug companies to give physicians journal articles that discuss product uses not yet approved by the FDA. The rules also state that drug companies do not need to promise to adequately test the unapproved use of the particular drug. The draft guidance would replace the FDA Modernization Act (FDAMA) of 1997, which expired in 2006. It included a provision allowing dissemination of information if the drug company met certain criteria.

While the decision is due this month, opponents and proponents have taken their stand, drudging up safety issues on one side and applauding the flow of information to doctors on the other.

"The draft guidance makes it easier for pharmaceutical companies to disseminate truthful, non-misleading information than it was in the past, which will ultimately benefit patients," says Daniel Margolis, litigation partner with Pillsbury Winthrop Shaw Pittman LLP, and a former federal healthcare prosecutor. "The draft guidance is a recognition that doctors prescribe drugs for off-label use all the time, and it makes sense from a public policy perspective to get that information into their hands."

Margolis does not believe that drug companies will be given carte blanche to use journal reprints as part of an off-label promotional campaign. Instead, he points out, the draft guidance imposes restrictions to ensure that the information is truthful and not misleading.

Margolis says the new guidelines state that information cannot include letters to the editor, abstracts or study reports, and must be accompanied by an article reaching contrary conclusions if available. All FDAMA required was a bibliography of other articles from scientific reference publications or scientific or medical journals that had been published about the use of the drug in question.

Also, a drug company need not seek FDA registration for the stated off-label use nor submit the article to the FDA 60 days prior to dissemination.

The Academy of Managed Care Pharmacy (AMCP), has not yet developed a formal response related to the draft guidance, but Marissa Schlaifer, RPh, MS, pharmacy affairs director for AMCP, says that the academy's concerns outweigh the potential benefits of the draft guidance. "On the plus side, since physicians, especially pediatricians, often prescribe drugs for off-label use, the availability of some medical information is better than prescribing without any information," she says.

Although manufacturer's sales representatives cannot directly provide physicians and plans with information about an unapproved use of a drug, they can assist physicians who wish to make unsolicited requests to that pharmaceutical company's medical information department.

"On the other hand, we're uncomfortable because there may be some manufacturers who use debatable methods to get their information published in peer-reviewed publications. Our concern is that there may not be enough safeguards to ensure the source of the information, which should only come from a peer-reviewed journal with an editorial advisory board," Schlaifer says.

The AMCP supports off-label use of drugs and coverage of such use, when it is shown to be medically appropriate by at least two peer-reviewed studies. "The use of drugs for off-label use is a reality," Schlaifer notes.

Mari Edlin is a frequent contributor to MANAGED HEALTHCARE EXECUTIVE. She is based in Sonoma, Calif.