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FDA/VA INTERAGENCY AGREEMENT

The Food and Drug Administration (FDA) and Veterans' Administration (VA) have agreed to work together to improve clinical knowledge of adverse effects of drugs used to treat HIV infection. Under an interagency agreement signed today, FDA and VA will jointly conduct an epidemiological study to determine whether avascular necrosis (AVN) -- the destruction of bone cells due to deficient blood supply -- that affects people with AIDS is linked to the use of certain drugs to treat HIV, or is a natural consequence of the viral infection.

The study will focus on cases of suspected AVN that are registered with the world's largest clinical database on HIV/AIDS, the Veterans Health Administration's centralized HIV Registry in Palo Alto, Calif., which contains data on approximately 50,000 patients, including 18,000 who are currently in VA's treatment.

The FDA will develop web-based software that will enable VA's clinicians to efficiently and confidentially augment the available information on these suspect cases with radiological data and other clinical detail necessary to confirm the diagnosis for AVN.

The resulting dataset, stripped of any information that could identify the patients, will be used by FDA to conduct the epidemiologic study. Depending on its outcome, FDA could take steps to change the labeling of certain antiviral drugs and inform prescribers.

FDA and VA believe that this initial project, which could be followed by similar studies focused on other AIDS-associated diseases, is an issue of mutual interest that can importantly benefit patient safety.

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