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June 5, 2011 marks the thirtieth anniversary of the initial report in the Center for Disease Control and Prevention's (CDC) MMWR of what would later become known as HIV/AIDS. Though mysterious in the early days, HIV/AIDS has not only had a profound effect on the planet in social and economic terms, but has led to new frontiers in science and technology as science grappled to discover and then probe the workings of the virus.
The Food and Drug Administration (FDA) has been involved since the start of the epidemic, and has been profoundly changed by it.
Once it became clear that HIV is a blood borne disease, FDA's Center for Biologics took action to change the way that human blood was collected, handled and blood products were treated. And because of the proliferation of unproven and bogus treatments, FDA established and supported a national network called the AIDS Health Fraud Task Force to help educate patients about treatment options.
Addressing the acute need to review a new realm of drugs to treat the Human Immunodeficiency Virus, FDA created a new review division, the Division of Antiviral Drug Products. This new division focused on bringing new treatments for HIV, as well as for associated opportunistic infections, to market. Since approval of the first Nucleoside Reverse Transcriptase Inhibitor, AZT (zidovudine) in 1987, more than thirty effective antiretroviral drugs and fixed-dose combinations to treat HIV have come to market, transforming HIV/AIDS into a manageable disease.
To interface directly with AIDS activists, and coordinate HIV/AIDS-related activities within the agency, FDA created another new office, the Office of AIDS and Special Health Issues in 1988. Today, the Office of Special Health Issues is the agency's primary liaison with a broad spectrum of patients and patient advocates - a constituency mostly unheard of before the AIDS epidemic.
FDA changed the way it approved drugs for serious and life-threatening illnesses in part due to the needs and demands of AIDS patients and advocates, which contributed to development of mechanisms such as accelerated approval, basing marketing approval on surrogate markers, which in turn, led to more innovative clinical trial designs.
AIDS activists ushered in a new era of patient action, impact and involvement. Those advocates, fighting for their lives, were able to challenge researchers and regulators in science and drug development to think in new ways.
AIDS advocates were the first patients to sit at the table at FDA advisory committee meetings. They not only brought the unique perspective of the patient to the discussions, but possessed scientific knowledge to meaningfully engage in the conversation.
Today, patient involvement is routine, and FDA incorporates patients on advisory committees to represent nearly all serious and life-threatening diseases.
FDA plays important roles in many areas of HIV prevention, diagnosis, and treatment. FDA's various HIV and AIDS activities are summarized on our web site.
FDA is also engaged in the global fight against HIV/AIDS, with special expedited review procedures to make "tentatively approved" generic and fixed-dose combination products available for the President's Emergency Plan for AIDS relief (PEPFAR). A complete list of approved and tentatively approved antiretrovirals in association with the President's Emergency Plan is available on the FDA web site.
You will find a comprehensive summary of FDA's response to the epidemic on the web site under the HIV/AIDS Historical Time Line.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
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