FDA task force
Jan. 04, 2005

by Julius A. Karash

The Manhattan Institute, a nonprofit New York-based think tank, has established a “21st Century FDA Task Force” to devise and promote better science-based regulations at the Food and Drug Administration.

The goal is to cut the time and cost required for new drug development, while increasing the safety and efficacy of the nation's drug supply, the institute said in a news release.

The institute said it now takes up to a decade, and can cost more than $800 million, to develop a new medicine for FDA approval.

“At the same time, recent safety concerns over pediatric antidepressants and widely used painkillers like Vioxx have riveted the public's attention on the FDA's inability to identify serious side effects until years after a drug is released on the market,” the institute said.

Merck & Co. in late September announced that it was voluntarily withdrawing its blockbuster arthritis drug Vioxx from the market because new data showed that it caused an increased risk of heart attacks and strokes. The action gave new urgency to a congressional investigation into how effectively the FDA handles drug-safety concerns.

The Manhattan Institute task force, which includes experts from academia, industry and the policy community, is expected to publish recommendation in the spring.

©2005 The Kansas City Star