Subject: Drug Firms Hope FDA To Speed Approval of Some Medicines
Date: Published: 10/21/88 82 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology:  
    Drug Firms Hope FDA Broadens Plan
    To Speed Approval of Some Medicines
    ----  
    By Michael Waldholz
    Staff Reporter of The Wall Street Journal

    Pharmaceutical companies hope the U. S. Food and Drug
 Administration's program to quicken approvals for drugs
 against AIDS or cancer will serve as a model for faster
 release of all experimental medicines.
    Drug industry officials generally applauded the FDA's
 announcement on Wednesday of the policy change, which had
 been in the works for much of the year and widely anticipated
 by drug companies.  But some company executives and FDA
 watchers viewed the new policy with caution and skepticism,
 saying that previous streamlining efforts by the agency had
 failed to meet expectations.
    Under the plan, the FDA said it will implement a program
 in which drugs for life-threatening illnesses and
 irreversible health problems can be evaluated for safety and
 effectiveness based on smaller and shorter human studies than
 presently required.  Drug companies and the FDA must design
 studies aimed at producing these earlier results.  Drugs
 approved this way would then be more closely monitored for
 potential problems once in use by doctors.
    Kenneth Berkowitz, a vice president at Hoffmann-La Roche
 Inc., the U. S. unit of the Swiss drug and chemical giant, F. 
 Hoffmann-La Roche & Co., said the drug industry sees the
 proposal to quicken the approval as part of the agency's
 recent efforts under Commissioner Frank Young to "expedite"
 the flow of new drugs.  Mr. Berkowitz and others said they
 hoped that if the faster release policy worked it could be
 extended to the approval of drugs for treating arthritis and
 heart disease, a process that currently can take years.
    Several drug company executives expressed concern,
 however, that if a new commissioner were to be named by the
 next president, streamlining efforts might stall.  "The
 bureaucracy at the agency needs Young's strong hand to keep
 them convinced that some drugs can get out fast," said one
 drug company official.
    Several industry analysts were dubious about how often the
 FDA and the drug companies would use the new rules.  Sarah
 Gordon, an analyst at Hambrecht & Quist, said, "Previous
 proposals have been more talk than action."  She noted that a
 program highly touted last year by the FDA to release some
 drugs before studies were completed had caused the early
 release of only one drug, a treatment for a type of pneumonia
 caused by the acquired immune deficiency syndrome virus.
    Also, Ms. Gordon said, some companies might not want to
 participate in the new program.  They have told her that the
 monitoring requirements under the new plan might actually be
 more difficult and expensive than doing lengthier studies
 prior to approval.
    Nancy Buc, a drug industry lawyer in Washington, D. C.,
 said many drugs for such diseases as cancer often have
 "subtle effects that only show up after very large trials."
 Ms. Buc, a partner at Weil Gotschal & Manges, said the FDA
 already can approve drugs based on early results, but that
 "few early tests ever show approvable results."  Her clients,
 she said, may be disappointed.
    But FDA staffers said several drugs still under study
 could have benefited from the new approach.  Ganciclovir, a
 drug for treating an AIDS-related infection, "could be widely
 available if the first tests done on it were better
 designed," said an FDA official.  Syntex Corp. of Palo Alto,
 Calif.  is testing the drug; officials there couldn't be
 reached for comment.
    Some activists who have pushed for FDA reform said the new
 rules don't go far enough.  "I think its crazy this program is
 voluntary," said Barry Gingell of the Gay Men's Health
 Crisis.  "Companies should be required by law to design
 streamlined studies."

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