Clarification

18 August 1996

Concerning the Pharmaceutical Research and Manufacturers of America's view of the Food and Drug Administration's environmental assessment proposals (Marketletter August 5), Thomas White, PhRMA associate vice president, manufacturing and quality control, points out that the revised EA rule would still require an assessment if a new drug in practice "endangered species/habitat" (see Section 25.21(b) p19,492 of the proposed rule).

He also says the Oregon Natural Resources Council has not opposed Bristol-Myers Squibb's Taxol (paclitaxel), which completed an EA and utilized an Environmental Impact Statement of the US Forest Service. The ONRC's issue relates to generic paclitaxel(s), which purportedly are relying on Canadian Pacific yew.

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