Nearly one-third of the new drugs approved by the Food and Drug Administration hit the market without any information comparing the medications to existing alternatives, information that might help doctors make better prescription decisions, a study says.
The authors of the study, published in the Journal of the American Medical Association, point out that drug makers are required to show only that their products are more effective than a placebo. The result, the researchers say, is that information on relative effectiveness is unlikely to emerge until years after new medicines are approved.
“There is a gap between the time the drug hits the market and the time this information is generated,” co-author Joshua Gagne, a pharmacist at Harvard Medical School, told Reuters.
Gagne and his colleagues analyzed public FDA data for 197 drugs approved between 2000 and 2010. Among the medications that compete against alternative treatments, 70 percent of the FDA approval packages contained some comparative data.
An official at the FDA’s Center for Drug Evaluation and Research, Dr. Robert Temple, took an upbeat view of the findings. He said “it is pretty impressive” that so many drug companies supplied comparative data given the lack of a requirement to do so.
But another expert not involved in the study, Dr. Alec B. O’Connor of the University of Rochester School of Medicine and Dentistry in New York, was critical. “When a new drug becomes available, if it’s not compared with a drug we already use, we don’t know if it is better or worse — we’re just guessing. If you’re a patient, I don’t think you would want your doctor to be guessing,” he said.
Gagne and his team recommend that comparative FDA information, when it exists, should be made more accessible. But Temple said that is not a clear-cut solution because such information is “often too limited to allow a firm conclusion about comparative effectiveness.”
