Subject: FDA to Shorten Testing Stage For Some Drugs
Date: Published: 10/20/88 66 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology:  
    FDA to Shorten
    Testing Stage
    For Some Drugs
    ---
    Plan May Speed Treatment
    For AIDS and Other Ills
    Seen as Life Threatening
    ----  
    A Wall Street Journal News Roundup

    The Food and Drug Administration said it adopted a policy
 aimed at speeding drug treatments to patients with acquired
 immune deficiency syndrome and other life-threatening or
 debilitating diseases.
    Under the policy, the agency will attempt to shorten
 significantly the human-testing stage for such drugs, which
 are normally tested in a three-stage process.
    The agency said it will work with drug researchers to
 design experiments that lead to more complete results during
 the first two stages of the human-testing process, thereby
 eliminating the final phase.  Under current procedures,
 scientists test for toxicity of a new drug in the first human
 trials.  In the second phase, usually on a small group of
 subjects, they test a drug for effectiveness before a much
 broader final phase conducted at several testing centers
 during a longer period of time.
    Human trials for many new drugs last three to seven years,
 after months of laboratory and animal testing.  The FDA then
 can take from three months to three years to approve a drug
 for general marketing, depending on the quality of the
 research data.
    Human testing on zidovudine, or AZT, the only FDA-approved
 drug for treating AIDS, was completed in a
 shorter-than-normal 14 months because the agency worked with
 researchers on the project.  The drug was then released for
 use by thousands of patients before it was officially
 approved for marketing.  This approach, the early release of
 still experimental drugs to patients in life-threatening
 situations, also will be speeded by the policy announced
 yesterday.
    Scientists and the FDA have been working to shorten the
 testing process on other new drugs.  For instance, in
 reporting results of toxicity tests, researchers often look
 for and disclose indications of how well a drug works against
 a particular disease, even though the trial usually involves
 only a small number of patients.
    The FDA said in a news release that the plan was developed
 at the request of Vice President George Bush, who served as
 chairman of the administration's Task Force on Regulatory
 Relief.  But an agency spokesman acknowledged that Mr. Bush,
 the Republican presidential candidate, wasn't mentioned in
 previous news releases on the subject.
    The vice president met with FDA Commissioner Frank Young
 last year about treating some patients with experimental
 drugs and again last August about the new policy, the
 spokesman said.

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