Subject: FDA Plan Set to Reform Drug Approvals; 3 Democrats Resist 
Date: Published: 11/14/91 (72 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology & Health:
    Plan Set to Reform
    Drug Approvals;
    3 Democrats Resist
    ----
    By Bruce Ingersoll and Hilary Stout
    Staff Reporters of The Wall Street Journal

    WASHINGTON -- The Bush administration issued a
 comprehensive proposal for overhauling the drug approval
 process, only to run into fierce opposition from three
 powerful Democratic lawmakers.
    The proposal, developed jointly by the Food and Drug
 Administration and the President's Council on
 Competitiveness, is intended to "knock years off" the time it
 takes to test and approve new drugs, said FDA Commissioner
 David Kessler at a news conference yesterday.
    The administration envisions creating a fast track for
 approving drugs to treat life-threatening diseases, such as
 AIDS and cancer, and hiring private research laboratories and
 other outside contractors to screen new drug applications.
 The avowed goals are to shave the average time for testing
 and approving drugs to seven years from the current 10, and
 to 5 1/2 years for drugs that treat life-threatening or
 incurable diseases.
    But congressional Democrats challenged the drug overhaul
 plan, charging that the FDA "appears to be abdicating its
 statutory responsibility" to rule on the safety and
 effectiveness of new drugs.
    In a letter to Dr. Kessler, Reps.  John Dingell of Michigan
 and Henry Waxman of California and Sen. Edward Kennedy of
 Massachusetts assailed the plan to allow private contractors
 to review certain drug applications, to have private review
 boards evaluate animal-test results, and to move toward
 accepting drug approvals by foreign governments.
    "We are concerned, at a minimum, that the proposals will
 lead to inconsistent and uncertain standards for review and
 could permit commercial interests to override the objectivity
 that is essential in evaluating drugs," the lawmakers wrote.
    The White House appeared unswayed by the letter of
 protest.  "We don't need Congress's permission to put these
 reforms into place," said David Beckwith, spokesman for Vice
 President Dan Quayle, who heads the competitiveness council.
    Speaking at a news conference, Vice President Quayle
 insisted, "I want to emphasize that these improvements will
 not -- and I underscore will not -- compromise safety in any
 way."
    The FDA would hire outside labs or medical centers only to
 review antibiotics, allergy medicines, anti-inflammatory
 drugs and analgesics.  The agency would continue to analyze
 applications for treatments of cancer, AIDS and other
 life-threatening diseases.
    The agency has long been under pressure from various
 groups to speed up the marketing of new drugs.
    Meanwhile, Rep. Ted Weiss, chairman of the House
 Government Operations subcommittee on human resources and
 intergovernmental relations, attacked the competitiveness
 council's growing role in FDA activities.  The subcommittee
 has been tracking what the New York Democrat called "wrongful
 interference" by both the competitiveness council and the
 White House Office of Management and Budget over the past
 four years.
    The panel voted unanimously yesterday to subpoena 153 FDA
 documents related to the administration's drug approval plan.

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