Subject: (Editorial):  Opening Up the FDA
Date: Published: 11/15/91 (106 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    REVIEW & OUTLOOK (Editorial):
    Opening Up the FDA

    If we are living through a year that saw real freedom
 emerge for the people of the Soviet Union, it isn't
 surprising that the year might end with perestroika for the
 U. S. Food and Drug Administration.  And for America's sickest
 people -- those ridden with AIDS, cancer, Alzheimer's,
 arthritis, cystic fibrosis and myriad other ruinous diseases
 -- their Boris Yeltsin is Vice President Dan Quayle.
    On Wednesday Mr. Quayle announced a series of
 administrative reforms intended to reduce the approval time
 for important new drugs.  Though not perfect, the Quayle
 Reforms mark an intellectual sea change in the U. S. 
 government's public attitude toward drug development.  While
 comics still get paid to tell stale jokes about him, Mr. 
 Quayle and his staff spent the better part of a year holding
 meetings, touching base with key players in and out of the
 medical-research community, debating, splitting the
 difference on some issues and finally pushing the U. S. 
 drug-approval process toward the modern era.  It's a
 noteworthy achievement.
    Of course it's also true that America's patients might
 have sacked the FDA's headquarters in suburban Washington if
 the agency hadn't come around.  AIDS patients had already
 invaded the building once.  Alzheimer's patients, led by the
 tireless and resourceful George Rehnquist, recently filed a
 class-action suit against the agency for its unendingly
 bizarre handling of the drug THA. 
    Breast-cancer patients have also organized themselves into
 a pressure group.  National Cancer Institute officials,
 working across the street from the FDA, had complained for
 years about the agency's approval criteria, but to little
 avail.  An FDA advisory committee's vote yesterday to leave
 breast implants on the market most likely had little to do
 with what any scientist thought about the devices but quite a
 bit to do with the prospect of having to answer to women with
 breast cancer.
    More recently, underground chemists have been formulating
 not-yet-approved drugs for use by the terminally ill.  You
 could make a persuasive case that if Soviet perestroika was
 driven into place as a result of internal collapse and
 outside pressure, so were these reforms.  The status quo
 simply couldn't go on.
    Whether the reforms -- contracting routine approvals to
 outside reviewers, accepting foreign data, new efficacy
 criteria, one or two fewer approval hoops -- will be acted on
 in any consistent way by the agency's employees remains a
 question.  This is the same bureaucracy that when asked this
 year by Congressman Henry Waxman to suggest new FDA
 enforcement powers came up with a wish list that included the
 authority for FDA agents to carry guns.  Add to this an FDA
 commissioner who on some days plays Rudolph Giuliani (with
 orange-juice makers in the role of Ivan Boesky) and on other
 days claims to be Mother Theresa, and you have an uncertain
 atmosphere for serious change.
    The day before this announcement, another part of the FDA
 was telling the developers of AIDS vaccines that they would
 not be able to use the exact kind of measurement to show
 efficacy that Commissioner David Kessler said at Wednesday's
 press conference the agency would soon be adopting.
    The fact remains that the proposals still reserve the most
 important decisions on breakthrough drugs to this
 bureaucracy.
    One crucial factor the proposals couldn't cover is the
 matter of who will protect the agency's approvers from the
 reactionary assaults of Ted Weiss and Mr. Waxman.  Rep. Weiss
 is already throwing a tantrum and screaming about
 investigating Vice President Quayle's Competitiveness
 Council.  Dr. Kessler has shown great courage so far in
 beating up on the makers of spaghetti sauce but not much
 appetite for taking on the Beltway heavyweights in Congress,
 the public-interest lobby or his own bureaucracy.
    While sick people have reason to wonder whether the FDA
 staff will make a good-faith commitment to the spirit of
 these proposals, their existence alone testifies to a change
 in the philosophy of medical regulation that probably can't
 be stopped or reversed.  Here, it is important to properly
 understand the role AIDS patients played in this change.
    The key weapon that AIDS patients brought to this effort
 was not their rage, but their brains.  In the past, mainline
 patients' groups for diseases such as Alzheimer's or cancer
 simply went along, assuming that the system knew best.  AIDS
 patients mastered the arcane vocabulary of research and
 regulation and set about exposing the indefensible illogic of
 the federal bureaucracy's rationalizations for its own
 inaction.
    The Quayle Reforms and Dr. Kessler's remarks Wednesday
 about "hearing loud and clear" the public's message are
 essentially recognitions that the smothering paternalism
 toward patients that was born out of the 1963 efficacy
 amendments is simply outdated.  This is an age of information,
 with a highly educated population keenly interested in
 developments in medical science (much of it supported with
 their tax dollars).  Amid this vast information exchange, the
 FDA's closed, byzantine system is an anachronism.  It's taken
 the efforts of a lot of smart and very seriously ill men and
 women, but the doors are finally starting to come open.

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