Off-label Drug Use Can Heal, But It Can Also Inflict Harm
by Cynthia Richardson was prescribed an asthma medication to stop premature labor, even though the drug’s label warned doctors that could be dangerous. She suffered a massive heart attack soon afterward.
Dr. Albert B. Einstein Jr. learned the breast cancer drug taxol might help his bladder cancer patients who were out of other options – even though taxol is not government-approved for them. Millions of Americans take medicines for reasons never approved by the Food and Drug Administration. This so-called off-label drug use can save lives but it also can kill – and Congress is struggling to find a balance as it debates legislation that could unleash a flood of new off-label prescriptions.
A drug goes on sale only after the FDA determines it is safe and effective against a particular disease. But once on the market, doctors can prescribe that drug for any disease. About 40 percent to 60 percent of all prescriptions are for uses the FDA has not approved.
Doctors learn about new uses for old drugs from medical meetings or scientific journals. Under federal law, drug makers cannot tell doctors about new findings, or even hand out copies of studies. The idea is that doctors are supposed to keep up with the latest science, not be swayed by a salesperson.
Now Sen. Connie Mack, R-Fla., has written legislation to let drug companies push unapproved uses of their products. Companies could give doctors certain research data, such as studies published in medical journals or presented at accredited education programs, as long as they reveal it is not FDA approved.
Mack, whose brother Michael died of cancer, wanted to ensure that patients got every shot at the latest medical findings.
But critics say patients could be hurt, because drug makers would reveal only the promising research and withhold the negative.
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