Magazine article FDA Consumer

Progress Reports in the Battle against Acquired Immune Deficiency Syndrome

Magazine article FDA Consumer

Progress Reports in the Battle against Acquired Immune Deficiency Syndrome

Article excerpt

Progress Reports in the Battle Against Acquired Immune Deficiency Syndrome

Inspections Find 1 of 9 Blood Banks Deficient

A year-long inspection program by FDA of the nation's blood and plasma collection centers led to 39 recalls of blood and blood components last year and an agreement by the nation's largest blood distributor, the American Red Cross, to tighten its operations.

From October 1987 through September 1988, FDA reviewed the records of 2,424 blood banks and plasmapheresis centers and found that 278, or 11 percent, were delinquent to some degree in following the agency's regulations for handling blood components. Thirty-nine of the inspections led to voluntary recalls, but no confirmed AIDS-contaminated blood was transfused. Most of the recalls were for human and computer errors involving, for example, incomplete testing procedures, distribution of some units that initially tested positive for the hepatitis B virus, and collection from unsuitable donors. FDA notified the centers of needed corrections.

FDA's routine inspections of these facilities had been intensified following several recalls of blood and blood plasma in March 1988 because of possible AIDS and hepatitis contamination. In an April 7 letter sent to all blood bank directors, FDA Commissioner Frank E. Young asked blood banks to review their operating procedures and improve their standards for computerization.

On Sept. 14, FDA signed an agreement with the American Red Cross, which handles approximately half of the 18 million units of blood products distributed each year. The Red Cross agreed to modify its operations to tighten control between its regions and national headquarters, improve its training and auditing, and analyze and redesign computer systems to ensure that unsuitable products are not released or transfused. FDA is working with other centers to improve their procedures as well.

FDA,s inspection program will continue to focus on procedures for donor screening, testing for hepatitis and AIDS virus antibodies, and for quarantining and destroying unsuitable blood products.

New AIDS Programs Passed by Congress

Legislation passed at the end of the 100th Congress provides for several new federal AIDS programs. Part of the Health Omnibus Programs Extensions of 1988 signed by President Reagan Nov. 4, the law authorizes 780 new positions in the Public Health Service over the next two years for AIDS activities.

It also establishes the National Commission on AIDS to, among other things, evaluate clinical studies of AIDS therapies and recommend ways to streamline FDA procedures for approving new drugs and devices and for releasing experimental drugs. The legislation also authorizes the National Institutes of Health, after consulting with FDA, to provide grants and contracts to community groups to conduct clinical studies of AIDS treatments.

Among its other provisions, the law requires that the Department of Health and Human Services: . evaluate the effectiveness and risks of unapproved drugs being used by AIDS patients; . set up a data bank that would include a registry of clinical trials and other information on experimental AIDS drugs; . encourage manufacturers of drugs potentially effective against AIDS to apply for investigational exemptions from FDA (so the drugs could be more widely available to patients)--HHS could provide technical assistance through grants or contracts to manufacturers, researchers and doctors; and . conduct research and education regarding AIDS and blood donations and transfusions.

The law also requires that grant programs for treating AIDS provide patients with information and counseling about both FDA-approved and unapproved therapies. Further, the National Institute of Allergy and Infectious Diseases, after consulting with FDA, is directed to establish an AIDS clinical research review committee to advise on appropriate AIDS research, including drug development. …

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