Subject: FDA Plans to Expedite Approval of AIDS Drugs
Date: Published: 9/6/88 34 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    FDA Plans to Expedite
    Approval of AIDS Drugs

    WASHINGTON -- The Food and Drug Administration plans to
 shorten the process of getting AIDS-related and certain other
 drugs to patients by compressing two parts of the current
 three-phase approval process for new drugs.
    Currently, in phase one a new drug is given to 20 to 50
 healthy volunteers over several months to determine the
 appropriate dosage and the drug's safety.  In phase two,
 several hundred ill patients are given the drug over a period
 that may last several years, to determine how effective the
 drug is and to discover any side effects.  Several thousand
 patients are given the drug in the third phase, during which
 safety, effectiveness and dosage levels are studied.
    FDA officials are awaiting approval from the Department of
 Health and Human Services to combine the second and third
 phases.  A drug manufacturer would be invited at the end of
 phase one to discuss ways the second and third phases could
 be combined.
    Previously, the approval process had been shortened for
 AZT, a drug that prolongs the life of some patients suffering
 from acquired immune deficiency syndrome, by giving the drug
 a special, high-priority category.  Since then, certain other
 drugs have been accorded similar treatment.

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