FDA Stringency "delaying New Drugs"

4 June 1995

The overall time taken for therapeutically-important new drugs to reach the US marketplace is longer than for standard New Drug Applications, a hearing of the House Commerce oversight subcommittee has been told.

The hearing, held to discuss reform of the Food and Drug Administration, heard written testimony indicating that during 1990-94 the time taken for priority new drug therapies, from Investigational New Drug filing to NDA approval, was 8.8 years compared with 8.2 years for standard products. The review phase during the period was faster for priority drugs, at a mean average of 1.6 years compared to 3.2 years for standard drugs, but the average clinical trial phase for the breakthrough products was 7.1 years against 5.2, according to the study, which was produced by Ken Kaitin, associate director at the Tufts Center for the Study of Drug Development.

In theory, the length of the clinical trial phase is determined solely by the product's sponsor, but the study believes that the increase in the number, size and complexity of such trials is due in part to the FDA's increasing regulatory stringency. "While stringent regulatory policies that demand extensive safety and efficacy data may reduce the likelihood of approving a drug that, with wider patient use, displays unacceptable toxicity, these policies may also delay the approval of valuable new medicines," it says. "Moreover, lengthy clinical development and regulatory review times serve as disincentives to pharmaceutical firms in their efforts to discover and develop new drugs."

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