Conversations on with Richard Klein, FDA


March 31, 2008

Q: Welcome to conversations on, I’m Ira Dreyfuss. Each month on we have conversations with government officials about HIV/AIDS issues. Today we’ll be speaking with Mr. Richard Klein from the Food and Drug Administration. Mr. Klein, welcome, and thank you for joining us today.

Richard Klein: Thanks so much for inviting me, Ira.

Q: What is the FDA?

Richard Klein: The Food and Drug Administration, unlike sister agencies in the Department of Health and Human Services, is a regulatory agency. FDA enforces the Food and Drug and Cosmetic Act and the Public Health Service Act assuring that drugs, biologics, and medical products are safe and effective for their intended uses and properly labeled. FDA’s activities help protect all consumers in the United States, regulating some trillion dollars worth of products each year. FDA sets standards for and monitors prescription and non-prescription drugs, blood products, vaccines, and tissues for transplantation, medical devices and equipment, radiation emitting devices, animal drugs and feed, cosmetics, and nearly all domestic and imported foods except meat and poultry.

Q: What is your role at the FDA?

Richard Klein: In October 1988, AIDS activists demonstrated at FDA headquarters effectively closing down the agency for a day. They wanted, among other things, a route of communication with FDA, a central point with which to interact. FDA responded by creating what was then called the Office of AIDS and Special Health Issues. The idea was to have one office and one person who would interface with AIDS patient advocates and activists. The office is special health issues is that office, and I’m that person. My role includes internal coordination of HIV related activities, policy development, advocacy, and communication. Much of my efforts are focused on involving patients in the regulatory activities of FDA assuring input and policy development processes and standards and product-specific decisions. I make sure that patients and advocates are informed of activities at FDA that affect them so they have an opportunity for meaningful input. Concerns from the patient community come to me and I see my job as advocating on their behalf within the agency. Through our patient representative program I help ensure that patient concerns and positions are represented at FDA advisory committee meetings and that patient input is considered in product development by involving them in clinical trial design and product labeling negotiations.

I also manage FDA’s HIV website, which can be reached from the FDA home page at using the “Information for Patients” button. The HIV pages provide a wealth of information about the different areas of FDA involvement with HIV and AIDS from lists of approved therapies and test assays to the records and transcripts of FDA public meetings about HIV and AIDS. I maintain a listserv that communicates important HIV/AIDS related activities at FDA including product approvals, important safety updates and significant labeling changes, notices of upcoming public meetings and proposed regulatory changes and opportunities for public comment. The listserv is open to anyone interested in HIV related activities at FDA; it’s simple to sign up on the FDA website.

Q: Would you please give us an example of how the FDA contributes to the fight against HIV/AIDS in the United States?

Richard Klein: Sure. While FDA does not provide direct healthcare services for HIV or AIDS patients, or actually develops new drugs itself, the agency is very involved in the fight against the epidemic. Let me give you several examples. FDA works closely with developers of new therapeutic products to assure that clinical trials are well designed, scientifically sound, ethically conducted, and appropriately analyzed. Agency staff provides valuable technical assistance to researchers and manufacturers of medical treatments. In addition, FDA reviews the data collected from clinical trials to establish the safety and effectiveness and ensures that risks are balanced with the potential benefits and works with sponsors to label products so that the risks can be minimized and managed.

Over the last few years FDA has played an integral role in the President’s Emergency Plan for AIDS Relief, or PEPFAR, by reviewing and certifying the quality and bioequivalents of generic drug formulations of HIV therapeutics for use under the PEPFAR program, as well as new combination products that make therapeutic adherence easier and help reduce pill burden. FDA also works with the pharmaceutical industry and the patient community to provide access to promising investigational or unapproved products available to patients who have no practical approved therapeutic alternatives available. Through such expanded access programs, tens of thousands of patients have had access to promising, but as yet unapproved HIV therapies over the years.

While most people think of FDA being involved in treatment, the agency also plays a major role in prevention. FDA assures the safety of the nation’s blood supply through oversight of blood banks and processing facilities, and companies who make blood-derived products, such as clotting factor, developing the necessary regulations and guidance to ensure that the blood supply is as safe as it can be. FDA also regulates and oversees the quality of barrier products such as condoms, medical gloves, and dental dams that can help prevent transmission of the virus. The agency also assures that approved diagnostic and blood screening tests are sensitive and specific for the detection of HIV in blood and other body fluids and for screening donated blood. Some of the tests are used to determine whether someone is infected so they can get into treatment. Other tests are used to manage therapy by monitoring the success of particular drug therapies in individual patients. FDA also plays an integral role in the development of both preventive and therapeutic vaccines for HIV and works closely with researchers and industry in developing microbocides that will hopefully prevent the spread of HIV by creating a chemical barrier to the virus.

Finally, FDA monitors food under its jurisdiction to ensure it is not adulterated or contaminated with pathogens and has educational programs about food safety for immunocompromised people.

Q: What actions would you like to see public health officials take, or continue to take, to help people living with HIV/AIDS?

Richard Klein: There are three areas; I hope to see continued and increased opportunity for participation by patients and their advocates in the areas that affect treatment and services to ensure that public health efforts better meet the needs of people living with HIV. I would like to see increased education in our schools to help give young people the knowledge and the skills that they need to help them avoid becoming infected with HIV. And, finally, I would like to see continued encouragement of women and minority enrollment in clinical trials, when appropriate, so that more specific safety and effectiveness data can be evaluated to determine whether any potential differences exist between different populations.

Q: Thank you for speaking with us today about the important work FDA is doing to help people living with or at risk for HIV/AIDS. To learn more about the FDA visit Please visit to view the transcript of this podcast. This podcast was created in partnership with the U.S. Department of Health and Human Services Office of HIV/AIDS Policy; the managing entity of

Last revised: 08/18/2008