WASHINGTON _ Senate Labor and Human Resources CommitteeChairwoman Nancy Kassebaum (R-Kans.) has set Feb. 21-22, 1996,as the dates to hear testimony on her FDA reform bill. But it still isunclear if she will gavel open those hearings with requisite supportfrom ranking Democrat Edward Kennedy (D-Mass.). (See BioWorldToday, Dec. 15, 1995, p. 1).
The conventional wisdom on Capitol Hill is that Kassebaum needsKennedy to move her bill through the Senate and obtain the supportof the Clinton Administration, according to several industry sources.But spokesmen for both Kassebaum and Kennedy remain cageyabout whether the two will be able to reach a compromise that willbear both names.
Kennedy's staff continues to negotiate with Kassebaum, according toKennedy press secretary Jim Manley. But Kassebaum health aideJane Williams denies there are any negotiations, saying she has onlybriefed the staff on the specifics of the legislation in an ongoing effort"to find a consensus."
Williams said she would "be delighted" if Kennedy co-sponsored thelegislation but admitted that "I don't know if we can accommodate allof his concerns." When Kassebaum's bill was introduced inDecember, it was notable for its lack of co-sponsors althoughconsiderable efforts were expanded to strike a compromise, saidseveral Washington sources.
Meanwhile, Kennedy's staff continues to hold out the possibility thatKennedy, who has been responsive to the concerns of biotechnologyin his state, may draft his own bill.
Another reminder that FDA control of promotion material remains adivisive issue on the committee appeared in the form of an op-edpiece that appeared in the Feb. 1, 1996, Washington Post, written bycommittee member Sen. Bill Frist (R-Tenn.). Frist made a pitch forhis bill, which is included in the Kassebaum FDA reform package,which allows distribution of information about the off-label use ofdrugs. Referring to a Jan. 19, 1996, Post editorial that urged cautionabout FDA reform, Frist wrote that "the FDA has a responsibility, asrightly pointed out in the editorial, to attend `to the safeguards thatpublic health demands.' At the same time, it must remember that itsmission is also to advance the public health. Finding the right balancebetween these two is the goal of the bill before the Senate."
Kennedy and Kassebaum's inability to reach consensus is only goodnews for FDA officials who continue to advise members of theSenate committee to proceed cautiously before amending the nation'sdrug laws, according to an agency spokesman. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.