WASHINGTON _ Calling the Republican legislation to revamp theFDA a "threat to the health of every American family that fills aprescription, relies on a medical device or eats a product containing afood additive," Sen. Edward Kennedy (D-Mass.) on Wednesdaywithheld his support from Sen. Nancy Kassebaum's (R-Kan.) FDAreform bill (S. 1477).

Kennedy made the announcement at a Senate Labor and HumanResources Committee markup of Kassebaum's bill.

By withholding his support from FDA legislation that in the past hastraditionally been approved by bipartisan and often unanimous votesby the committee, Kennedy effectively has reduced the chances thatthe bill will clear the Senate.

Despite last-minute negotiations between staff members of theDemocratic and Republican members of the committee, Kennedy andKassebaum ultimately were unable to agree on how much to privatizeFDA reviews and mandate tougher product review timetables.

Kennedy and Kassebaum consistently have worked together as abipartisan team, making Kennedy's defection all the more striking.During markup Kennedy repeatedly reminded his colleagues that in1976 and 1990 important FDA legislation was reported out of thecommittee unanimously.

But several Democrats broke rank with Kennedy on important issues,indicating that many arguments for FDA reform, especially thosevoiced by the medical device industry, had supporters on both sidesof the aisle. Several Democrats, including Sens. Barbara Mikulski(D-Md.) and Chris Dodd (D-Conn.), voted with the Republicans tocreate a three-year demonstration project to test the concept ofcontracting out the review of medical devices, including Class IIIcritical devices requiring premarket approval.

The committee approved by a vote of 11-4 an amendment offered bySen. Dan Coats (R-Ind.) that would require the FDA to accredit theprivate review agencies and approve financial arrangements betweenthe reviewer and manufacturer, a potential conflict of interest thatproduced serious misgivings among Democrats. FDA would retainfinal approval of the private review determination. Kennedy stronglyopposed the amendment charging, "While it makes sense to initiate apilot program to third-party reviews it is unfair to start this programwith the most critical Class III devices."

The committee rejected language sought by Kennedy that would havesoftened the powerful effect of the "hammers," those provisions inthe Republican bill that would have forced the FDA to contract outreviews if it did not approve new medical products within themandated six-month time frames. Instead, an escape clause wasoffered to the agency so it could report to Congress when itanticipated it would not meet the review deadlines and additionalappropriations could be provided to the agency.

An amendment offered later by Sen. Tom Harkin (D-Iowa) to limitthe pilot projects involving private reviewers to just Class I and IImedical devices was rejected. However, the split among thecommittee members indicates that the language may be revisedbefore the bill goes to the Senate floor for a vote.

Kennedy did prevail on persuading Kassebaum to strike from the billprovisions sponsored by Sens. Connie Mack (R-Fla.) and Bill Frist(R-Tenn.) that would have permitted drug and device manufacturersto disseminate information about off-label uses of their products.Dissemination of off-label uses was the most contentious issue in theFDA reform bill. "We tried to address these issues but a consensushas eluded us," Kassebaum said. "We hope to reach a compromisebefore the bill comes up for a Senate floor vote."

Also approved was a Coats amendment to limit the FDAcommissioner to one five-year term not to coincide with thepresidential term. Current FDA Commissioner David Kessler wouldbe grandfathered under the provision.

The committee approved by unanimous consent an amendmentsponsored by Sen. Paul Wellstone (D-Mass.) striking language fromthe Republican bill that would have denied consumer representativeson FDA advisory committees the right to vote on product approvals.

The committee is expected to resume deliberations today when it willconsider several more Kennedy amendments including language thatwould permit the FDA to focus its resources on reviewingbreakthrough drugs. Kennedy is concerned the shortened reviewtimes in the Republican bill "would force the FDA to review productstoo quickly and would deny the agency the resources it needs foradequate reviews under accelerated time schedules." n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.