Ladies and gentlemen and interested parties; my name is Dr. John G. Bartlett, M.D., and I serve as a professor of medicine and chief of the Division of Infectious Diseases at Johns Hopkins University School of Medicine. The purpose of this statement is to urge BPAC and FDA support for the availability of an FDA-approved, rapid, oral fluid HIV test for over-the-counter use.
There is ample data available today to support the broader availability of the new rapid HIV testing technology. This technology has been FDA approved since late 2002 and since then more people than ever are learning their HIV status and receiving treatment and prevention counseling as a result of this simple, highly accurate, rapid HIV test. Many feel that providing access to this technology over-the-counter would remove some of the barriers to HIV testing that currently exist, and therefore result in more people getting tested to learn their HIV status. The reason is obvious: this knowledge facilitates prevention and access to life-saving care.
For the estimated 25 percent of those living with HIV in the United States who do not know their HIV status, access to an over-the-counter oral fluid testing option that is simple, safe, and effective will promote HIV detection.
I welcome the opportunity to assist you in this dialogue going forward and ask that a copy of my remarks be entered into the record.