PhRMA Views Env Assessment Plans

The Pharmaceutical Research and Manufacturers of America has estimated that the Food and Drug Administration's proposal to require environmental assessments only for products with an environmental concentration of one part per billion or more will reduce by 90% or more the amount of environmental information that will need to be submitted as part of marketing applications.

The proposed new rule is opposed by the Oregon Natural Resources Council, which says that if applied it would not require an EA for applications relating to paclitaxel (Bristol-Myers Squibb's Taxol), which is derived from the Pacific yew tree.