WASHINGTON _ FDA Commissioner David Kessler Wednesdaycriticized Sen. Nancy Kassebaum's (R-Kan.) FDA reform bill forinadvertently contributing to drug review delays and warned that thebill encompassed some regulatory risks.
But he promised to work with the committee to negotiate acompromise on critical issues.
Kassebaum gaveled her hearing to order facing stacks of a 50,000-page product licensing application filed in 1988. Kassebaum used thepiles of documents to illustrate the burden of the FDA regulatoryprocess. She is searching for legislative approaches to reduce thetime from discovery to marketplace and called for new expectationsfrom the FDA including imposition of strict statutory deadlines fordrug reviews.
Kessler labeled as "unrealistic" the mandatory requirement inKassebaum's bill that all drugs be reviewed within 180 days.
He warned that the safety and efficacy standard could be threatenedby the legislation. "While it is unlikely, an absolute time frame couldlower the standard of safety and efficacy and put companies in adangerous situation." In addition, a tight time frame could result in"applications being turned down, adding cycles to the approvalprocess," Kessler said.
"If the drug is an important drug we can make a concerted crasheffort because lives are at stake," Kessler added. But he resistedattempts by Kassebaum and others to expedite approval of all drugs,saying the requirement would "would not permit us to set prioritiesand would take away from what we are trying to do."
Several members including Kassebaum used the example of FDA fastaction on AIDS drugs to prod Kessler into agreeing to work moreclosely with manufacturers to sort out unresolved issues before thedrug application reached FDA's threshold.
Kessler pledged his commitment to improving communicationsbetween the agency and drug companies "early on in the process. Justas user fees enabled the agency to get down the review times, we nowmust deal with the time before an application gets to the agency," hesaid.
Speedy approval of AIDS drugs appeared to be the benchmarkagainst which several committee members graded the FDA'sperformance. But Kessler reminded the members that severaltherapeutics, including those for diseases such as breast and ovariancancer, multiple sclerosis, cystic fibrosis and Lou Gehrig's disease,all had been placed on the fast track at the FDA.
He cautioned that such fast approval times require "an excellentapplication, the agency literally waiting at the door, an intenseamount of discussion, and a dialog with the manufacturer."
How many review activities the FDA should contract out to privatecontractors occupied a considerable amount of the give and takebetween Kessler and committee members.
Sen. Dan Coats (R-Ind.) called the agency's attitude that dismissedthe ability of third-party reviewers to impart important scientificknowledge to the review process "arrogant." He warned Kessler that"you can't get support of Congress on this issue because it is toodisgruntled with your delays."
Kessler maintained that "our experience with the contracting processis that it may lengthen the process."
Kessler told BioWorld Today that he refuses to contract out reviewfunctions just for the sake of delegating them outside the agency. Hesaid he wants a coherent plan that "builds on our strengths inimproving the drug approval process."
Sen. Barbara Mikulski (D-Md.) said that while contracting FDAfunctions to outside reviews involved issues of conflict of interest,data confidentiality and propriety information, these are "yellowlights" to consider, not obstacles that should stop debate.
However, after being pressed by several members of the committeewho made it clear that privatization of some FDA review functions isa foregone political reality, Kessler conceded that "we can do more"and told the committee that he was "willing to take risks especiallywhen patients benefit."
But he added that "one day we are going to make a mistake" andpredicted he would be back before Congress facing questions such as"where was the FDA?"
Sen. Bill Frist (R-Tenn.) predicted that Kessler would have to acceptprivatization and that it was simply a matter of "defining how far wecan go."
International Harmonization Sparked More Debate
Kessler also pledged "to do more" to facilitate internationalharmonization of drug review requirements. "We already acceptforeign data but we need to standardize our requirements." But heasked the committee to "name an important drug that is available inEurope but not available here."
Kessler had to withstand several questions from the committee aboutwhy the FDA holds itself as the only authority on drug approvals,spurning review decisions made in Europe and Japan.
Mikulski asked why the U.S. military accepts European armamentstechnology but the FDA won't accept their drug approvals.
Sen. Edward Kennedy (D-Mass.) who holds the key to working out abipartisan compromise with Kassebaum, was staunchly defensive ofthe FDA's record. "It's important to recognize today the good workat the FDA. It has taken the brunt of criticism."
Wednesday's hearings represent the beginning of committee debateon FDA reform. Even though FDA reform bills have been pending inthe House for nearly a year, today's action is just about on schedulecompared to other Congressional debates on changing FDA'sauthorizing statute. Both the 1992 drug user fee bills and the 1986safe medical device amendments consumed at least three years forCongress to shape the debate and find a suitable compromise. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.