WASHINGTON _ Sen. Edward Kennedy (D-Mass.), who for morethan 30 years has spoken out on behalf of a strong FDA and criticizedthose who have sought to dismember the agency, is emerging as thedeal maker in negotiations over pending FDA reform legislation inthe Senate.
Several drug company lobbyists told BioWorld Today thatKennedy's willingness to accept or reject certain provisions in theFDA reform bill (S. 1477) proposed by Senate Labor and HumanResources Committee Chairman Nancy Kassebaum (R-Kan.) willdetermine if the legislation advances or dies in committee. (SeeBioWorld Today, Dec. 15, 1995, p. 1.)
South San Francisco-based Genentech vice president for governmentaffairs David Beier said it is too early to predict if Kennedy andKassebaum would be able to reach a compromise.
Kennedy has not yet announced whether he can support Kassebaum'sproposal. Kennedy press secretary Jim Langley said the senator'sstaff is negotiating with Kassebaum's aides but declined to discussany specifics noting that "we don't like to negotiate in public." Headded, however, that if the negotiations bore no fruit, Kennedy woulddraft his own FDA reform plans.
"Kennedy is a key figure," said Lisa Raines, Cambridge, Mass.-basedGenzyme vice president of government relations. "It's very difficultto get any bill through the Senate that does not have bi-partisansupport. If Kennedy throws his weight behind Kassebaum's bill, thatwill indicate the Democrats in the Senate can support it," said Raines.
"Even more importantly, Kennedy's support is also an indicator ifPresident Clinton will sign the bill," she added.
Kennedy, who over the years has been a stalwart supporter of FDACommissioner David Kessler, also has strongly backed the biotechindustry in his state, said Raines. The unfolding debate may raise thepossibility that Kennedy may have to choose between the provincialinterests of the Massachusetts biotech industry and his ideologicalcommitments to Kessler. If the Biotechnology Industry Organization(BIO) continues to press for an absolute ban on FDA control ofpromotional materials it could force Kennedy to choose, said Raines.
BIO president Carl Feldbaum played down Raines' assessment ofKennedy's pivotal role on the committee, saying each member waskey to enactment of FDA reforms.
He also deflected suggestions that FDA reform would not advance tothe Senate floor because the industry won't compromise on keyissues. "We want BIO's proposal to get a full airing at the upcominghearings before we talk compromise," Feldbaum told BioWorldToday. "However, we are mindful that Congress is equipped only toenact incremental reforms."
Imminent legislative activity was signaled by a spate of rushedmeetings among drug company lobbyists and negotiations among thestaff members of the Senate Labor and Human Resources Committee.
After several weeks of inactivity as the nation's capitol was firstparalyzed by the now suspended budget negotiations and then winterstorms, drug interests are hopeful a reform plan can be coaxed out ofKassebaum's committee.
Lobbyists for drug and medical device trade associations said theyare hoping the Senate Labor and Human Resources Committeeadvances a bill before presidential politics can introduce any morepartisanship into the legislative process. "We all feel a sense ofurgency," said Raines. "The bill must pass both houses before thissummer or it won't have a chance in the 1996 presidential electionpolitics."
Lobbyists expect Kassebaum to hold hearings within the next fewweeks on her bill and a proposal jointly authored by BIO and thePharmaceutical Research and Manufacturers of America (PhRMA).A third industry proposal is supported by the Health IndustryManufacturing Association, representing medical devicemanufacturers.
Rep. Thomas Bliley (R-Va.) who chairs the House CommerceCommittee has promised hearings on FDA reform before the end ofthis month. His staff has prepared three draft FDA reform bills, oneaddressing the concerns of synthetic and biotech drug manufacturers,another for improved regulation of medical devices, and a thirdinvolving foods. Bliley still has not announced if Rep. MichaelBilirakis (R-Fla.) whose health subcommittee has jurisdiction overauthorizing legislation, will hold hearings. Commerce Oversight andInvestigations Subcommittee Chairman Joe Barton (R-Texas) hasheld a series of hearings on FDA but his subcommittee cannot writelegislation. (See BioWorld Today, Nov. 16, 1995, p. 1.) n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.