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  U.S. Department of Health and Human Services | National Institutes of Health

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In 1978, and following efforts over several years, FDA finalized regulations to help lessen the likelihood of hepatitis contamination of blood through labeling. Research suggested a significant difference in likelihood of such contamination from paid blood donors rather than volunteers. Henceforth, blood intended for transfusion had to be labeled as either paid or volunteer sourced.

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Hepatitis was a major focus of the Bureau of Biologics’ blood regulatory program early on, from checking the proficiency of blood banks to conduct hepatitis tests, to collaborative research on the virus using animal models with National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC), to further study of donor selection criteria.

Following two meetings of its external advisory Panel on Safety and Effectiveness, which considered published and unpublished data on coordinated clinical trials conducted across the nation, the advisors broadly concurred with the Bureau that Hepatitis B immune globulin was safe and effective for Hepatitis B prophylaxis. Thus, in 1977 the Bureau issued the first license for this product in post-exposure prophylaxis in the event of accidental encounters such as needle sticks, laboratory accidents, and similar situations.  

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A woman in a white lab coat wearing gloves checks a kit used by blood banks and other facilities to test blood for hepatitisImage Removed

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Linda Smallwood of the FDA Bureau of Biologics checks a kit used by blood banks and other facilities to test blood for hepatitis (from FDA Consumer November 1977). 

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FDA History Office

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A woman in a white lab coat wearing gloves checks a kit used by blood banks and other facilities to test blood for hepatitisImage Added

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Linda Smallwood of the FDA Bureau of Biologics checks a kit used by blood banks and other facilities to test blood for hepatitis (from FDA Consumer November 1977). 

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FDA History Office

Non-A, non-B Hepatitis Antigen attracted more research attention of Bureau scientists in 1978. This antibody system was detected using the older counter-electrophoresis test. It was found in s of 7 experimental animals infected by another animal infected with the same antibody system. Also, the same antigen was collected over 5-6 years from a patient suffering chronic hepatitis. That patient transmitted the same antigen to a nurse who experienced an accidental needle stick, and the patient’s antigen also was transmitted to an animal model. By mid-1984 90 percent of post-transfusion cases of hepatitis and up to 40 percent of community acquired cases in the U. S. were non-A, non-B. Though the agent had not yet been identified, research shed more light on its characteristics. It appeared to be a retrovirus or retrovirus-like entity, and additional observations of the agent in a half-dozen samples of serum- or plasma-based products brought the Office of Biologics Research and Review (OBRR), what biologics regulation at FDA was called in the early 1980s, closer to develop screening tests for non-A, non-B.

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