NAPWA salutes FDA Advisory Committee for recommending approval of OTC home HIV test
NAPWA salutes FDA Advisory Committee for recommending approval of OTC home HIV test, urges public education about implications of both positive and negative test results
(Washington, D.C., May 16, 2012) - The National Association of
People With AIDS (NAPWA) Drugs Advisory Committee for recommending approval of OraSure's OraQuick In-home HIV Test kit. We
urge the FDA to follow the Advisory Committee's recommendation and approve the kit for over-the-counter sale.
With an estimated one-fifth of Americans who live with HIV unaware they are infected, there is an obvious need for
more testing and more ways to get tested. There are people who need to get tested who will not do so in a traditional medical
setting. We hope many of them take advantage of a home test kit to learn their status, so they can seek treatment for their
infections, stay healthy, and take steps not to infect their partners.
We recognize that some who receive a positive result from the home test kit will be traumatized and need
immediate emotional support and suicide prevention assistance. Others will need help understanding the HIV health care
system and the care options they have. We urge OraSure and the FDA to provide 24-hour toll-free hotlines for people
who need help coping with their test results or finding treatment and support resources.
We also call for a major public information campaign when in-home test kits become available in pharmacies
without prescription, emphasizing that HIV is treatable but left untreated can kill, that people receiving effective
treatment are less likely to transmit HIV to others, and that they may be eligible for ADAP and other Ryan White
programs if they do not have meaningful private health insurance. The campaign should also explain that there
is a small risk of false positive and false negative results, that it may take three to six months for a new
infection to be detectable, and testing negative does not mean one can stop practicing safe sex.
"We welcome in-home testing," said Stephen Bailous, Executive vice President of NAPWA and Chairman of the Washington, D.C.
EMA Ryan White Planning Council. "We know there are risks in allowing people to test themselves for HIV without counseling, but we also
know we are still seeing more than 50,000 new HIV infections every year, and a large majority of them come from sexual contact with
people who do not know they have the virus. Reducing the number of undetected, untreated HIV infections will bring the number of
new infections down. In-home testing is one of many new testing and treatment options that promise to bring the end of AIDS in America."
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The National Association of People with HIV/AIDS (NAPWA)Founded in 1983,
NAPWA is the largest and oldest advocacy organization for PLWHA, and the most trusted voice in the HIV/AIDS community advocating for the
lives and dignity of all people living with and affected by HIV/AIDS, especially the more than 1.2 million Americans living with it
today. To learn more, visit www.napwa.org.
Source: http://www.napwa.org/content/napwa-salutes-fda-advisory-committee-recommending-approval-otc-home-hiv-test
CONTACT:Paul DeMiglio
(240) 247-1018
pdemiglio@napwa.org
"Reproduced with permission - "National Association of People with HIV/AIDS (NAPWA) "
National Association of People with HIV/AIDS (NAPWA)
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