WASHINGTON _ The next two weeks promise to be critical forFDA reform legislation. Hearings scheduled for Wednesday andThursday this week in the Senate Labor and Human ResourcesCommittee and next week in the House Commerce HealthSubcommittee will reveal if a consensus exists in Congress to enactFDA reforms this year.
Last year FDA reform legislation never advanced because of aprotracted stalemate between President Clinton and CongressionalRepublicans over a seven-year deficit reduction package. (SeeBioWorld Today, Sept. 14, 1995, p. 1.) This year the threat may bePresidential politics which tends to derail some proposals whilebringing others to center stage depending on the political advantageeach conveys.
In the two previous major reforms of the FDA undertaken byCongress in 1986 and 1992, partisan politics were not a factor. ButWashington has changed in the past two years. House Speaker NewtGingrich (R-Ga.) set the tenor for FDA reform early last year whenhe injected conservative, antigovernment considerations into thedebate. (See BioWorld Today, Jan. 11, 1995, p. 1.)
FDA Commissioner David Kessler has not been unaffected by theconservative tide that swept Washington. He has worked hard in thelast year to mitigate support for an FDA overhaul. After a combativeappearance before the Senate Labor panel last April (see BioWorldToday, April 7, 1995, p. 1), Kessler has met his critics half way inrationalizing the FDA review process. Time and again Kessler hasresponded to criticism that FDA drug and device approval processescan be expedited. In a high profile announcement at the White Houselast November Kessler, and top Administration officials announcedseveral regulatory initiatives to consolidate regulation of biotechdrugs and make regulatory standards comparable to those used toclear synthetic drugs for marketing. (See BioWorld Today, Nov. 10,1995, p. 1.)
Kessler closed out 1995 with a major speech before the Food andDrug law Institute that denied the existence of any drug lag with othernations and detailed how much drug review times have been reducedin the last three years. (See BioWorld Today, Dec. 14, 1995, p. 1.)
Whether Kessler's accommodations will go far enough to amelioratethe determination of Republican conservatives to ease the regulatoryburden on manufacturers may be seen in the next two weeks.Congressional action on FDA reform thus far has been dominated byconservatives who appeared to be driven by an ideological mission toeliminate the FDA as a market barrier.
Ideology dominated the debate in oversight hearings held by Rep. JoeBarton (R-Tex.). Barton's hearings focused on the FDA's refusal toapprove a handful of products _ most of them medical devices _and did not explore a new paradigm for regulatory review.
However, proponents of FDA reform in the next two weeks will haveto move past partisanship and focus on forging a consensus behindFDA reform legislation. The handful of conservative Republicanswho were so vocal at Barton's hearings need a majority of the 46members of the House Commerce Committee to get the bill to theHouse floor for a vote.
In addition to finding common ground on FDA reform, next week'sCommerce hearings will provide some insight into whether healthsubcommittee chairman Michael Bilirakis (R-Fla.) is committed tomoving FDA reform legislation. All hearings to date have been heldby Barton's oversight and investigations panel, not the authorizingsubcommittee which Bilirakis heads. While his panel alone controlsFDA legislation, Bilirakis did not appear at any of Barton's hearingsand has made no statement on the record about his views on FDAreform.
House Commerce Committee Chairman Tom Bliley (R-Va.),however, did attend two of Barton's hearings and in recent weeks hasgiven his views on the principle of FDA reform. He told a recentconference sponsored by the Progress and Freedom Foundation thathe backs legislation to permit private contractors to review drug anddevice applications using FDA criteria for safety and efficacy. (SeeBioWorld Today, Feb. 8, 1996, p. 1.)
How much House Speaker Newt Gingrich (R-Ga.) will be able toclear a path for FDA reform bills through the House is also anunknown. While Gingrich has told representatives of biotechcompanies in private meetings that he wants a bill to clear the Housethis year, said industry insiders, Bliley has already noted that 1996Presidential politics may derail any proposal.
Committee Consensus Is Critical
Consensus among committee members also will be a critical issue forSen. Nancy Kassebaum (R-Kan.) when she gavels open this week'shearing. Kassebaum has traditionally moved health legislationthrough her committee with the bipartisan support of Sen. EdwardKennedy (D-Mass.). But Kennedy has thus far been reluctant to takea position on Kassebaum's bill. Kennedy is expected to back her billbut may extract significant concessions in order to do so, say industryobservers. While she has sought them out, Kassebaum has not beenable to attract any co-sponsors to her proposal.
In addition to Kennedy's support, Kassebaum needs to secure thesupport of key conservatives on her panel including Sen. Bill Frist(R-Tenn.) who authored several provisions in her bill that roll backthe FDA's authority over promotional literature.
The issue of whether the FDA should have the authority to denyphysicians access through drug companies to journal articles thatdetail off-label use of a drug may be the defining issue in this year'sdebate. How effective Kessler has been in convincing members ofSenate and House authorizing committees not to tamper with FDA'sauthority in this area may also be seen at the hearing. According toseveral industry sources, Kessler has lobbied members of thecommittee hard not to weaken the FDA's power over promotionalmaterials. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.