Subject: FDA Locks Horns With Lilly Over Drug Testing
Date: Published: 12/12/91 (74 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology & Medicine:
    FDA Locks Horns
    With Eli Lilly & Co. 
    Over Drug Testing
    ---
    Company Runs Into Trouble
    When It Tries to Follow
    Streamlined New Policy
    ----
    By Bruce Ingersoll
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- Was Eli Lilly & Co. pulling the Food and
 Drug Administration's chain, or was the huge drug maker
 really testing the Bush administration's commitment to
 speeding up the marketing of new drugs?  
    It depends on whom you talk to.
    On Nov. 13, the President's Council on Competitiveness and
 the FDA announced a sweeping plan to streamline the
 drug-approval process.  The avowed goals are to cut the
 average time for testing and approving drugs to seven years
 from the current 10 years, and to 5 1/2 years for drugs
 desperately needed to treat AIDS and other deadly diseases.
    A fact sheet released by the competitiveness council said,
 among other things, that the FDA "will immediately permit"
 drug companies to bypass the agency altogether when it comes
 to initial testing of new drugs on humans.  Instead, they need
 only obtain the approval of an "institutional review board"
 at a hospital or medical school.
    Indianapolis-based Lilly, it appears, took the council,
 chaired by a Hoosier, Vice President Dan Quayle, at its word.
 But it also appears that the FDA regards the use of the word
 "immediately" as a slipup.
    On Nov. 14 or Nov. 15, a company lobbyist telephoned the
 FDA to see if the fact sheet was indeed correct, according to
 an FDA memo obtained by Rep. Ted Weiss.  She was told that
 Lilly couldn't begin testing any drug on a review board's
 say-so.  What's more, according to the memo, she was told that
 such boards say "they don't have the capability to adequately
 review investigational new drugs for safety and don't want
 responsibility for approving such testing."
    This didn't deter Lilly.  In a Nov. 21 letter, the company
 notified the FDA that it has asked an Indiana University
 review board for clearance to begin testing a new drug for
 Alzheimer's disease.
    The FDA, facing a bold challenge to its authority, went
 ballistic.  Paul Leber, a senior drug-review official, took
 Lilly's letter as apparently "a notice of an intent to
 violate existing law," according to another FDA memo.  Dr. 
 Leber telephoned a Lilly executive on Dec. 3 and laid down
 the law:  There won't be any drug-testing changes until the
 FDA changes the drug-testing regulations.
    This didn't satisfy Rep. Weiss, who had gotten wind of
 Lilly's testing plan.  In a letter yesterday to the FDA, the
 New York Democrat demanded an even tougher response, warning
 that Lilly's "actions may ultimately jeopardize the health of
 unwitting volunteers in clinical trials."
    Yesterday, the company said it has called off its
 Alzheimer's drug-testing plan.  Which brings us back to the
 original question about Lilly's intentions.  On the one hand,
 the FDA's Dr. Leber says he has the impression that the
 company was "merely tweaking the system."  On the other hand,
 when asked if Lilly was seriously testing the
 administration's resolve to speed up drug approvals, Lilly
 spokesman Edward West replied:  "That's a fair
 characterization."

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