Monday, November 13, 1995
Last week's pow wow in the Indian Treaty Room of the Old Executive Office Building, during which Vice President Al Gore and FDA Commissioner David Kessler released a package of FDA reforms, provides some reminders on the virtues of political activism in general and of the biotechnology industry's non-partisan position in the Washington maelstrom in particular.
The ceremony represented more than an important set of reforms (see BioCentury Extra Nov. 10), because the concerns the agency addressed are not new. Regulations mandating lot-by-lot certification of products, stringent establishment licensing for biologics and other regulatory approaches that draw sharp distinctions between biological and chemical therapies are artifacts of an earlier age when "biologics" meant live vaccines and unrefined blood products. The industry has pointed out these and other regulatory anachronisms in the past. To paraphrase Marx, the problems have been