House Panel Rips Plan to Alter Drug Approval System : Regulation: The Quayle council’s proposal may slow the process, endangering consumers, the report says.

WASHINGTON — The Bush Administration’s plan to change how the Food and Drug Administration approves new drugs would undermine the agency’s ability to make sure that medicines are safe, a House committee report says.

The House Government Operations Committee report is a 27-page attack on Vice President Dan Quayle’s Council on Competitiveness and its call for altering the FDA’s operations.

“The Quayle Council’s recommendations strongly resemble the ‘wish list’ it received at a secret meeting with the drug industry last year,” the report says. “The Quayle Council’s initiatives may well slow down drug approvals, while exposing consumers unnecessarily to dangerous drugs.”

A confidential copy of the report, approved 24-14 by the committee, was obtained by the Associated Press.

The committee recommends that the FDA junk the ideas of the Quayle council.

Quayle spokesman Jeff Nesbit rejected the committee’s criticism.

The committee’s complaints came from an investigation earlier this year by its human resources subcommittee, whose chairman, the late Rep. Ted Weiss (D-N.Y.), said Quayle and the White House had twisted arms at the FDA to get the changes adopted.

The complaints center on proposals to have the FDA have private contractors review new drug applications and have the companies submit applications for clinical trials to special boards, usually at universities or hospitals, instead of the FDA.

The report also criticizes plans for accelerated approval of new drugs, saying it should be limited to treatments for serious or life-threatening conditions.

The Quayle council would have allowed this for “any condition, regardless of its severity, when the condition lacks satisfactory alternative therapy.”