RX\Good Rx ... or bitter pill?

Byline: Fran Kritz Medical Tribune News Service

Many prescription drugs approved by the U.S. Food and Drug Administration for one illness also are useful against other diseases. But FDA rules prohibit drug companies from widespread promotion of these so-called "off-label" uses, which critics say prevents vital treatment information from reaching doctors and their patients.

In response, two U.S. senators have introduced a bill that would allow companies to promote off-label uses of their products by providing doctors with journal articles that recommend such uses.

"This legislation will greatly increase one's odds of getting state-of-the-art treatment that could cure a disease, slow the progression of a disease or at a minimum, improve one's quality of life," said Sen. Connie Mack, R-Fla., who co-sponsored the bill with Sen. Bill Frist, R-Tenn., who is a doctor.

Under current regulations, the FDA approves a drug or device for specific conditions or diseases. Once a single approval has been granted, doctors may prescribe the product for other, unapproved uses.

An estimated 40 percent of all drugs are used for off-label indications, and 70 percent of cancer drugs are used that way, according to Mack.

Currently, companies can respond to doctors' queries about off-label uses, but cannot send out information unless a request is made.

"It is true that ... information could be provided in response to a specific physician's inquiry, but it is impractical to imagine that every doctor would make such a request," said Dr. Bruce Chabner, clinical director of the cancer center at Massachusetts General Hospital in Boston.

The proposed legislation would allow drug companies to send out unabridged articles from major medical publications, such as the New England Journal of Medicine and the Journal of the American Medical Association, that report on unapproved uses of a drug or device. Companies also could send out textbooks and conference summaries on unapproved uses of a product.

The legislation has the support of medical groups such as the American Heart Association and the American Medical Association. But some witnesses told the Senate's Labor and Human Resources Committee on Thursday that the bill could allow the dissemination of information that eventually proves incorrect.

William B. Schultz, deputy FDA commissioner for policy, told the Senate committee that two drugs approved to correct abnormal heart rhythms, encainide and flecainide, subsequently were used off-label for irregular heart rhythms during a heart attack - a use that was supported by several journal articles.

But when the National Institutes of Health studied this off-label use, it found that the death rate among heart-attack patients given the drugs was twice that of those given a placebo.

"If this unapproved use had been heavily promoted by drug companies, it is estimated that thousands more unnecessary deaths would have occurred," Schultz said.

Acknowledging that drug companies are reluctant to spend the time and money necessary to get off-label uses of their products approved by the FDA, Schultz said his agency will try to move applications for these types of approvals through the system more quickly.