HIV/AIDS Update - Statement from FDA Commissioner Margaret Hamburg, M.D. on World AIDS Day 2011

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Title: HIV/AIDS Update - Statement from FDA Commissioner Margaret Hamburg, M.D. on World AIDS Day 2011

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You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

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For more than two decades, World AIDS Day has allowed us to remember those who have died from AIDS and to acknowledge those living with or caring for people with HIV/AIDS. While the disease is a reality for more than 34 million people around the world every day, for one day each year we have an opportunity to focus attention on the progress made during the past year to prevent and treat HIV and AIDS-related conditions.

This year’s theme – “Getting to Zero” – is particularly relevant for FDA as we play a vital role in the fight against HIV/AIDS. The agency reviews and oversees all drugs, biologics and medical devices intended to prevent, diagnose and treat people living with HIV/AIDS and AIDS-related conditions. FDA also helps to ensure the safety of the blood supply, monitors and assures the quality of barrier products such as condoms and surgical gloves that can help prevent the transmission of HIV, and plays an important role in the development of preventive and therapeutic vaccines.

Since 2004, FDA has approved more than 137 generic formulations of drugs and new fixed-dose combination products to treat HIV in support of the President’s Emergency Plan for AIDS Relief (PEPFAR). In 2011, FDA approved a new test to help detect the HIV infection earlier, approved three new HIV drugs that provide patients with additional treatment options, and expanded the indication of an existing therapy for use in children.

The work of people within FDA has resulted in truly meaningful changes in prevention and treatment for people living with HIV/AIDS, not just here in the United States but around the world, particularly in supporting access to drugs through the PEPFAR program. On this day, we remember those who have lost their battle against AIDS and reaffirm our commitment to approving new and effective therapies that will encourage greater drug adherence and move us closer to our goal of preventing the spread of the disease – and, ultimately, to getting to zero.

 

 


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