Physicians Don't Wait for the FDA to Act: Aspirin Makers Hail New Decision
Goldreich, Samuel, The Washington Times (Washington, DC)
Washington obstetrician Dr. Bruce Bonn makes a regular habit of ignoring the Food and Drug Administration in prescribing drugs for his patients.
While the federal agency fields an army of bureaucrats and professional advisory panels to approve new drugs and new uses for existing pharmaceuticals, Dr. Bonn regularly recommends birth control pills for purposes that have not been approved.
Like doctors across the nation, Dr. Bonn routinely practices medicine without waiting for the FDA to catch up with the latest scientific developments. And it's perfectly legal.
That paradox was underscored yesterday when an FDA advisory panel recommended allowing aspirin makers to label their product for use in the prevention of heart attack and stroke. Although aspirin makers have been allowed to market the drug as a treatment for patients in risk of a second stroke as long ago as 1980, they could not tout many of the other benefits of the drug's blood-thinning properties.
Likewise, while Dr. Bonn is free to tell his patients about all the benefits of the birth control pill, its manufacturers are allowed only to market it according to the limitations cited in FDA-approved labels. In fact, FDA regulations prohibit drug companies from touting their products' unapproved uses to doctors unless they receive a specific request for information.
"The use of oral contraceptives for their non-contraceptive benefits - what is considered off-label uses - is very common," he says. "With the spread of AIDS and other [sexually transmitted diseases], people should be using condoms for the most part. Now, we are actually using birth control pills for their non-contraceptive benefits."
Among the diseases and problems that numerous studies report the pill is useful in treating are uterine and ovarian cancer, pelvic inflammation, excessive menstrual bleeding, and cramps. But any drug firm that circulates such studies would be breaking the law.
Off-label usage is so widespread that the General Accounting Office has reported that doctors prescribe more than 50 percent of cancer drugs for treatment in cases that have not been approved by the FDA.
All that would change under a general FDA reform bill drafted by the Pharmaceutical Research and Manufacturers Association, which wants to allow manufacturers to circulate peer-reviewed medical literature that reports new drug uses.
"We should be able to disseminate such information as soon as it's available rather than wait until it is approved by the FDA," said Mark Grayson, a spokesman for drug trade group.
A similar off-label reform bill failed last year, but Republicans have vowed to make it a priority as part of FDA reform this year. …