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Donohue: Testimony Before the FDA’s Blood Products Advisory Committee (Over-The-Counter HIV Test)

Posted Nov 17 2009 9:25pm
Testimony Before the FDA’s Blood Products Advisory Committee

Good Afternoon.

My name is Tom Donohue, I am the founding director for Who’s Positive, a national HIV/AIDS awareness organization which for years has advocated and provided opportunity for young adults to be tested for HIV across the country.

It’s hard to believe that four years ago I spoke before this panel imploring you folks for swift action in approving a rapid over the counter HIV test. Since those four years hundreds of thousands have become infected right here in the United States. According to the Kaiser Family Foundation, 21% of those infected with HIV don’t know it. 53,300 people were infected in 2006. 21% of them – a very alarming 11,823 people don’t know. 34% of those 53,300 people were between the ages of 13 and 29. That was my group – 6 years ago when I became a statistic – when I found out I was HIV positive. I was just a young thriving student whose life was about to implode, simply due to one moment – a moment of passion of intimacy of irresponsibility. As a whole I blend in with everyone, as an individual I have a face, a story, family and friends whose life have been and will be affected for the rest of their lives.

Today, Who’s Positive is releasing the results of a survey, which shows, overwhelming support of an FDA approved, rapid, over the counter, mouth swab HIV test which could be purchased at a retail store. This survey shows 78% of over 700 surveyed would support this type of test. These results further prove the need and importance of such a test. Not only do I believe this type of availability of HIV testing will test many more people, I also believe this test will break down stereotypes and barriers to testing but it will also open much needed conversation about HIV and HIV testing. It’s hoped that you’ll be able to walk into a store walk to a shelf and purchase a test, which will give someone wanting to know their status the power to know. It’s important to note – that this is not replacing testing in clinical settings or at an ASO, it’s simply an additional tool – an additional option that consumers have to choose the best method for them to know their status.

As the final steps are being taken to move this type of test forward, I travel to you today to once again tell you the importance of moving this forward, but not in another four years – we can’t wait four more years. Today society worries about the amount of people infected and dying from H1N1 virus – but we already have a virus that is killing so many more a day, and infecting way too many in the United States – let me introduce you to it, its three characters instead of four, it’s been around a lot longer and it too doesn’t discriminate against anyone – it’s called HIV – and this committee has seen and heard evidence about a new tool in this fight against it. This tool will help reduce infections, empower people to know they’ve been infected and its time – its time to bring this tool to the shelves of our local retail store so that this tool can be used in the fight myself and many more are fighting. I fight it for people I know and don’t know, I fight it for the people who will become infected – for people who are infected and I fight it for my family. You… you all need to fight for it – fight for this tool and bring it to reality – Yesterday was too late and tomorrow is not soon enough to bring this tool to reality.

I thank you for your time and I ask you to continue support this tool and for swift action in making it a reality.

Tom Donohue

Founding Director, Who’s Positive

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