FDA Reform Fails

THE DAILY FED

FDA Reform Fails

A House Republican source close to negotiations with the Clinton administration over legislation to reform the FDA drug approval process last week attributed the failure of talks to a growing reluctance by the administration and House Democrats to reach agreement. The source noted "a chill in the air" in the period heading up to the Democratic National Convention in August. House Commerce Committee aides had been in negotiation with HHS staff since July. The measure, which the Commerce panel has not yet marked up, would partially privatize the approval process for drugs and medical devices. Rep. James Greenwood, R- Pa., leader of the House Commerce FDA reform task force, last week said the issue is dead this year.

But other sources disputed the assertion that the administration and Democrats were reluctant to reach agreement. One source said the Democrats are willing to talk, but have had no contact from Republicans. Another source said the administration has no control over whether the two sides will meet and that Republicans have declined to call any new meetings since Congress returned from its August recess. The source said the talks had been making progress, but Commerce Committee GOP staff refused to sign off on issues that had been resolved until negotiators worked out a final agreement, adding negotiators remained far apart on "big-ticket" items. One House source said a bill still is possible, but it would have to come from the Senate.

A spokesman for Senate Labor and Human Resources Chairwoman Kassebaum said Kassebaum is still working to get a time agreement for floor consideration of FDA reform legislation approved by her committee. However, Labor and Human Resources ranking member Edward Kennedy, D-Mass., has spoken out strongly against the measure, and a Kennedy spokesman said the tight FY97 appropriations schedule may rule out floor consideration of FDA legislation. The House GOP source argued that even without a bill, the FDA reform effort has been a partial success because the political attention forced the agency to make internal reforms and speed up the approval process. The source added that with so much progress, House Republicans may be able to pass a stripped-down version of the bill.