FDAnews Drug Daily Bulletin

FDA OFFICIAL: AGENCY NOT INTERESTED IN COMPARATIVE TRIALS

July 5, 2006
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The FDA is rejecting the efforts of some healthcare groups to use head-to-head trials between different drug products as part of new drug applications, arguing that these tests are less efficient or effective than placebo-controlled tests, a high-ranking agency official says.

The FDA does not want comparative data from drug sponsors, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said at a recent conference. This pronouncement comes as the agency has seen an upswing in the number of drug sponsors that have submitted this type of data as part of their new drug applications.

While comparative studies are useful in some situations, such as cancer treatments, where using a placebo would be unethical because not treating the disease can lead to death, in most cases placebos are much more effective in demonstrating a product's effectiveness, Gottlieb said. It simply is too difficult, the agency believes, to discern benefits of a drug when it's compared with another similar treatment, as opposed to a placebo.

"We don't think [comparative] trials are very valuable," he said.

However, some healthcare and activist groups, including Consumers Union, the Pharmaceutical Care Management Association and the Alliance for Better Healthcare, a healthcare benefits group, argue that further use of comparative studies provides patients with additional information necessary to make the best treatment decisions.

Other government offices have weighed in on the practice. Earlier this year the Agency for Healthcare Research and Quality began an initiative to determine the best treatments for a variety of health threats using comparative studies. (http://www.fdanews.com/did/5_129/)