AIDS/HIV Research, Testing, Therapeutics, Policy at FDA
In the early years of the AIDS epidemic, when the pathological signs were understood and the sudden growth of cases were documented while the etiology remained unclear, the Office of Biologics Research and Review (as the principal functions of the FDA Bureau of Biologics were renamed when the drugs and biologics functions were combined under the Center for Drug and Biologics from 1982 to 1987) and other components of the Public Health Service were gathered to understand and combat this outbreak. The Office of Biologics Research and Review (OBRR) investigated the virology and immunology of the syndrome, how it affected various biological products, and staff screened new biologics that might be brought to bear against AIDS. For example, the observation that AIDS patients could not manufacture the necessary T-cell response to address one common opportunistic infection—from cytomegalovirus, suggested (based in part on in vitro tests) that interleukin-2 deficiency could be behind the syndrome. FDA and NIH collaborated on a phase 1 study in this regard.
Dive
class
grid-col-4
Image Modified
Span
class
caption
Drs. Thomas Folks and Guide Poli in their laboratory for AIDS research at the National Institute of Allergy and Infectious Diseases (NIAID).
