Subject: FDA's Probe Prompts Red Cross to Agree To Tighten Its Blood-Safety Procedures 
Date: Published: 5/10/93 (69 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    FDA's Probe Prompts Red Cross to Agree
    To Tighten Its Blood-Safety Procedures
    ----
    By Rose Gutfeld
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- The American Red Cross, responding to government
 findings that it has violated blood-safety laws, agreed to tighten
 its procedures to ensure the safety of its blood supply.
    The Food and Drug Administration, announcing the consent decree,
 said that the blood supply is safe and that the Red Cross has
 already made a substantial commitment to accomplishing many of the
 goals in the agreement.  The FDA's concerns involved lack of
 safeguards and inadequate record-keeping, not an increase in the
 amount of tainted blood.
    "For any patient requiring a blood transfusion, the risk of not
 receiving that transfusion outweighs the risk of receiving blood,"
 said FDA Commissioner David Kessler.
    Still, the agency said that its investigators found violations of
 laws and regulations at various Red Cross facilities -- despite a
 voluntary 1988 agreement in which the Red Cross agreed to correct
 problems brought to light at that time.
    In the new consent decree, the Red Cross agreed to establish a
 comprehensive quality-assurance program and to improve its
 management and employee training.  It also will work on its computer
 systems and its policies for investigating and reporting errors,
 accidents and adverse reactions.  The decree, which includes
 timetables for making the changes, will be enforceable by court
 order.
    Fred Kyle, the Red Cross's senior vice president of biomedical
 services, said the agreement establishes priorities consistent with
 a $140 million "transformation program" launched by the organization
 two years ago.  "In the age of AIDS, nothing about blood can be
 business-as-usual, either in blood banking or in our government," he
 said.  "We will leave no stone unturned in our effort to meet the
 goals set out by the FDA.  "
    Separately, members of a joint FDA advisory committee were split
 on whether to recommend that the agency require labeling of milk
 from cows that have been injected with genetically altered hormones.
 The agency hasn't yet decided whether to allow the use of such
 hormones, which increase milk production.  The hormones are produced
 by Monsanto Co., American Cyanamid Co., Upjohn Co. and Eli Lilly &
 Co. 
    The panel, which consisted of the FDA's Food Advisory Committee
 and Veterinary Medicine Advisory Committee, didn't try to reach a
 consensus on what to recommend.  Many members essentially said that
 use of the bovine growth hormone doesn't alter milk and doesn't
 result in any health consequences for consumers.  They also said that
 labeling wouldn't provide useful information.  These panelists voiced
 worries that labeling would be difficult to enforce and could have
 significant, unwanted implications for other products, especially
 bioengineered ones.
    Others, however, argued that consumers have a right to know
 whether their milk has been produced with the hormones.  This group
 generally contended that use of the hormones does alter milk and
 that labeling could be accomplished and enforced practically.
    The question of whether to allow the use of the hormone has been
 hotly debated by both consumer groups and dairy producers as well as
 within the FDA for some time.  It isn't clear when the FDA will
 decide the issue.

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