Food and Drug Administration - December 1, 2005
Richard Klein

December 1 is World AIDS Day.

From the first, isolated reports in 1981, AIDS has grown into a global pandemic. Despite efforts in every nation, the epidemic continues to grow. While HIV/AIDS seems to have faded somewhat into the background in the United States, rarely making front page headlines as it has in years past, the epidemic is still present in this country. There are more than a million people living with HIV and AIDS in the United States today, and an estimated 38 million worldwide.

AIDS and HIV infection have become part of the American narrative over the past twenty four years. It is a now part of the fabric of our nation, and that of nations around the world.

FDA has played a strong role in addressing treatment and prevention from the beginning of the epidemic. FDA has made significant contributions to the development and availability of potent antiviral drugs that have dramatically helped people with HIV and AIDS live longer, healthier lives.

The agency has played an important role in improving medical treatments, providing access to promising investigational products, helping to prevent the transmission of HIV through regulation of barrier products, protection of the blood supply, and oversight of the development of vaccines (both preventive and therapeutic) and microbicides.

World AIDS Day commemorates those that have died from AIDS. It also serves as an opportunity to think about how we can help support the individuals, families, and communities affected by HIV and AIDS, and renew our commitment to preventing the spread of the disease, developing and delivering more effective treatments, and finding a cure.

You can find a comprehensive chronology of significant events in FDA's involvement in the fight against HIV on the FDA website at

http://www.fda.gov/oashi/aids/miles.html

1981-1990: This decade saw the first report of AIDS and its identification as a retrovirus, approval of the first immunoassay test, approval of the first drug to treat AIDS (AZT), the first drugs for treatment and prevention of certain opportunistic infections, and a mechanism for expanded access to promising therapies prior to approval.

1991-1994: These years saw the creation of the National Task Force on AIDS Drug Development, large-scale expanded access to pre-approved HIV therapies, and approval of a number of new drugs. Accelerated approval permitted earlier approval of therapies based on surrogate marker activity. The first non blood-based collection system was approved to test for HIV, and a female condom was approved, providing women with a barrier product that didn't rely on a woman's partner to use.

1995-1999: The final years of the century saw approval of the first protease inhibitor, a new class of drugs for treating HIV, the first home-use AIDS test kit, the first antigen test kit to screen blood donors for HIV-1, and the first viral load test.

2000-present: In the first years of the 21st century, new formulations and combinations of medications were approved to reduce pill burden. Other approvals: HIV genotyping to help improve treatment outcome, the first nucleic acid test for plasma screening, the first rapid HIV test for use in outreach settings, the first fusion inhibitor for treating HIV/AIDS, and the first generic formulations of drugs to treat HIV/AIDS.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

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SOURCE: Food and Drug Administration (FDA).

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