WASHINGTON - FDA Commissioner David Kessler continued to erect the agency's bulwarks against FDA reform, releasing a "White Paper" that seeks to discredit the Drug and Biologic Products Reform Act of 1996 (H.R. 3199) and the three other reform bills developed by the House GOP.

Testifying last week to the Commerce Committee's subcommittee on health and environment, Kessler asserted that H.R. 3199 "eliminates much of our ability to protect human subjects." He also charged that privatization of product reviews, which Republicans have made a cornerstone of all three FDA reform bills, amounts to allowing manufacturers to "buy" their reviews.

The strength of his opposition was not matched by Republicans in their defense and appeared to surprise them. Rep. James Greenwood (R-Penn.), who has been assigned by Commerce Committee Chairman Thomas Bliley (R-Va.) to shepherd H.R. 3199, expressed disappointment at the vehemence of FDA's opposition. Greenwood said he hoped the testimony marked the maximum of the distance between the committee's Republicans and FDA, and said the bill is a "work in progress."

Talk of compromise

Greenwood suggested a compromise on third-party review, by allowing FDA, not sponsors, to select the private review entity. The proposal would address the conflict-of-interest arguments raised by Kessler and the commissioner's congressional supporters.