WASHINGTON _ True to their revolutionary aims, HouseRepublicans have introduced FDA reform legislation that goessignificantly further than the Senate package in revamping theagency's duties and powers. The House's more aggressive planbrought a proportionately feistier response from FDA CommissionerDavid Kessler, who testified for three and a half hours here onWednesday before the House Commerce Committee's subcommitteeon Health and Environment.
Kessler's remarks kicked off two days of hearings that focused onthree pieces of legislation designed to overhaul regulation of drugsand biologics, medical devices and food and animal health products.The Drugs and Biologics Reform Act of 1996 (H.R. 3199) seeks tostreamline FDA regulation of new medicines by instituting a systemof third-party review of marketing applications, imposing strictdeadlines on FDA actions, allowing companies to submit summariesof their clinical data rather than vast compilations of raw data andaltering the efficacy standards required for drug approval, amongother things.
Kessler came out swinging against H.R. 3199 in its current form,suggesting that it could undermine the FDA's ability "to protectAmerican citizens from unsafe and ineffective products." WhileKessler's spirited defense of his agency's performance is nothing newon Capitol Hill, his attack on the system of third-party review wasparticularly pointed.
Unlike the bill which was voted out of the Senate Labor and HumanResources Committee in March and which proposed a pilot programof third party review, H.R. 3199 seeks to establish a system of third-party review immediately, without extensive testing. Kessler said theprospect of privatizing the FDA's review functions, as proposed in allthree House bills, was "extremely troublesome."
"[These bills] would allow the review of these products and claims byreviewers who are paid by the industry to perform the review,"Kessler told House lawmakers. "In some instances, FDA would havea short, not very meaningful, opportunity to review the decision ofthe third party before that decision becomes final."
H.R. 3199 states that the recommendation of an accredited third partyto approve or deny an application will be deemed to be approved byFDA unless FDA finds that there is a reasonable probability that thedrug is not safe or effective. The FDA must make that decision andpresent its case within 60 days, a provision that effectively shifts theburden of proof from drug application sponsors to the FDA.
Industry proponents of third-party review argue that the Europeanmodel of drug and device regulation, which is based upon third-partyreview of applications by so-called "notified bodies" (NB) thatpossess full regulatory authority, is superior to the U.S. system. Butthe issue has become one of dueling studies and claims _ and theHouse hearing was no exception.
For example, Kessler cited a Government Accounting Office (GAO)study published in March to support his claim that third-party reviewraises some thorny conflict-of-interest issues. The GAO concludedthat the NB system could present some ethical dilemmas since itplaces NBs in the "complicated position of both performing a publichealth function" and "having a client relationship with themanufacturer." In addition to review work, the GAO noted that someNBs provide consulting services to companies, potentiallycompromising their independence. Also, NBs are in constantcompetition with each other to secure the business of manufacturers.
Kessler emphasized his concerns about third-party review in alengthy written statement delivered to legislators on Wednesday."Because there is a risk that only third parties that err on the side ofapproving applications and petitions will succeed in this market,there is a risk that the incentive will be for third parties to approveapplications and petitions _ not to critically review them," wroteKessler. "If what this bill is trying to accomplish is getting safe andeffective products on to the market, broad privatization will notaccomplish that end."
According to Biotechnology Industry Organization (BIO) presidentCarl Feldbaum, neither third-party review nor any other singleprovision of H.R. 3199 should be regarded as a "bill-wrecker.""Those who would politicize this process will single out one item oranother and BIO has never done that," Feldbaum told BioWorldToday. "It's not the individual provisions but rather the wholepackage, the whole range of options to streamline and shorten drugreview and development time that will achieve meaningful FDAreform."
Feldbaum said that introduction and consideration of the House FDAreform bills builds on the momentum established with the Senate bill.Although he conceded that it would be an "up-hill battle" to get anFDA reform bill passed and signed into law this year, he said thatboth Democrats and Republicans are considering what politicalbenefits might be gained from moving on the issue.
House Republicans, once shrill critics of the FDA bent onoverhauling the agency, did sound a more conciliatory note in the twodays of hearings that ended Thursday. They refrained from openlylambasting Kessler during his testimony, instead offering assurancesthat the House bills are not "set in stone."
The shift in tone could signal that Republicans are serious aboutachieving bipartisan legislative reform of the agency in the 40legislative days left in 1996. It could also reflect a mellowing dictatedby the changing landscape of American politics _ an attempt toradically restructure the FDA could leave Republicans vulnerable toattacks during the fall campaign.
The fate of FDA reform this year is likely inextricably linked tocampaign politics. "There is a great deal of political eyeballing goingon right now," explained Feldbaum. "People are asking who will thislegislation benefit more _ Republicans or Democrats? How muchcontroversy can a campaign year handle?" Feldbaum saidbiotechnology industry executives met with Senate majority leaderand presidential contender Bob Dole (R-Kan.) during the NewHampshire primaries and urged him to schedule floor time for a voteon the Senate bill called the FDA Performance and AccountabilityAct (S. 1477), before election politics make legislative actionunrealistic.
The House is scheduled to mark up H.R. 3199 and the companionbills covering devices and foods sometime in June, setting the stagefor a vote on a composite bill in mid-summer. n
-- Lisa Piercey Special To BioWorld Today
(c) 1997 American Health Consultants. All rights reserved.