WASHINGTON _ Senate Labor and Human Resources CommitteeChairwoman Nancy Kassebaum (R-Kan.) was forced to cancel hermark-up of FDA reform legislation scheduled for today after aconsensus failed to develop in support of the bill. The mark-up hasbeen rescheduled for next week.
The crush of legislation now pending in the Senate committee alsodelayed drafting of Kassebaum's version that would go to mark-up,until Monday night, an administration source told BioWorld Today.
Kassebaum and Sen. Edward Kennedy (D-Mass.) have beennegotiating over several basic concepts in the her bill (S. 1477). Thenegotiations resulted in Kassebaum abandoning what had beenreferred to as "hammers," penalties that would have been imposed onthe FDA if drug approvals did not meet statutory deadlines. ButKassebaum and Kennedy were unable to draft mutually acceptablelanguage that would permit drug companies to distribute promotionalmaterials on off-label uses of drugs and devices, Kennedy's presssecretary said.
The stalemate in the Senate Labor and Human Resources Committeebore out predictions made more than a year ago by industry lobbyistswho said FDA controls on promotional materials would be the makeor break issue on FDA reform.
The House Commerce Committee sprang into action on FDA reformjust as the Senate appeared to falter. After months of promising thatFDA reform legislation would be soon introduced, committeechairman Thomas Bliley (R-Va.) announced a task force ofRepublicans who would introduce several bills to revamp variousaspects of the FDA, ranging from drug and biologics reviews to foodsafety. Rep. Richard Burr (R-N.C.) a freshman Republican who lastsummer grilled FDA Commissioner David Kessler during anoversight hearing on FDA, has been anointed by Bliley to introducelegislation to reform all drug reviews, including biotech therapies.
The use of a task force of committee members rather than asubcommittee chairman to push the bill through the committeelegislative process, is a departure from usual Congressionalprocedure. But one Congressional aide said the creation of a taskforce is not as important as the fact that Bliley has finally signaled hisinterest to move FDA reform legislation. A hearing on the yet-to-be-introduced FDA reform bills has been scheduled for March 20, 1996,when members of Congress will testify about the various reformplans. Kessler also is scheduled to testify.
While bipartisanship has been the hallmark of negotiations in theSenate Labor and Human Resources Committee, it is not the case inthe House. Reps. John Dingell (D-Mich.) and Henry Waxman (D-Calif.) have not been involved in any of the discussions withcommittee Republicans, according to a Congressional aide.
Washington insiders afforded a number of predictions about whetherthe chances for FDA have been enhanced or diminished by theweek's events. Even Biotechnology Industry Organization PresidentCarl Feldbaum hedged his bets about whether a bill would pass thisyear.
Feldbaum said that is possible the "bill will slip until next year,although we have made good progress this year." n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.