The final action on a recommendation by an FDA advisorycommittee that the agency approve Bristol-Myers Squibb Co.'staxol for marketing must await completion of an environmentalimpact statement (EIS) on the effects of harvesting the rarePacific yew tree.
According to Bruce Manheim, a senior attorney with theEnvironmental Defense Fund in Washington, D.C., the U.S. ForestService, the lead agency responsible for preparing the EIS, hadscheduled a draft document to be completed by October, withthe final version to be issued by spring 1993. But the draft hasbeen delayed until mid-December, pushing the final version tosummer 1993.
"Unfortunately, the Forest Service has been a little slow,"Manheim said, "which may in turn affect the rate at which theFDA may be able to reach a final decision on the use of taxol inthe clinic."
Manheim told BioWorld that usually only one federal agency isresponsible for preparing an EIS in a given situation, but thisEIS has been complicated due to the involvement of threeagencies: the U.S. Forest Service, FDA and the Bureau of LandManagement.
The EIS will evaluate the various harvest regimes for thePacific yew tree, from which taxol is derived, in a five-yearprogram. Manheim said he doesn't see any opposition byenvironmental groups to the EIS and harvest of taxol, butanticipates a possible requirement to chart an approach tomeet taxol demands while harvesting the yew tree in asustainable way.
Taxol is also being studied as a treatment for lung and breastcancers. Approximately 60 pounds of bark from the rare Pacificyew tree is necessary to produce enough taxol to treat onepatient.
On Monday an FDA advisory committee recommended thatBristol-Myers Squibb of New York be given approval to markettaxol for ovarian cancer.
-- Michelle Slade Associate Editor
(c) 1997 American Health Consultants. All rights reserved.