For an AIDS-Free Generation: Access to Drugs and Diagnostics Is Essential

By: FDA Commissioner Margaret A. Hamburg, M.D. and HHS Assistant Secretary Jimmy Kolker

Margaret Hamburg, M.D.On World AIDS Day this year, tens of millions of people with HIV are now living healthy, productive lives because of access to safe and lower priced medicines. We rejoice in this achievement, because all people, no matter how rich or poor, deserve to have the medicines they need to live their lives in the best health possible.

We can truly see in our future an AIDS-Free generation because of the wide availability of prevention and treatment tools. But the availability of these drugs and diagnostic tools, especially in Africa, was never a given. Ten years ago, in 2004, the U.S. Food and Drug Administration (FDA) committed to support the President’s Emergency Plan for AIDS Relief (PEPFAR) by introducing an expedited review process to make generic and low-cost treatment more readily available for the most affected countries. PEPFAR requires antiretroviral drugs to be safe, effective, and of high quality and supports their distribution to people needing treatment around the globe. But meeting these requirements can be costly and time-consuming. Those suffering from AIDS cannot wait. The FDA, an agency that is part of the Department of Health and Human Services (HHS), applied the tentative approval process in order to increase dramatically the number of products approved for purchase and distribution by PEPFAR.

Thanks to the commitment of FDA scientists, as of today FDA has issued expedited approval decisions for 179 products, including 39 formulations specifically designed for children that allow flexible dosing across multiple weight bands and many innovative formulations, such as fixed-dose combinations and co-packaged products that improve adherence to treatment and reduce the risk of developing resistance. The 179 tentative approvals allowed PEPFAR to purchase products at a lower cost, leading to cost savings of hundreds of millions of dollars. These savings contributed to additional patients being able to receive treatment.

Jimmy KolkerAccording to UNAIDS, by June 2014, 13.6 million people around the world had access to antiretroviral therapy. This is an important success, but many more people still need access.

Unfortunately, too many countries lack the regulatory capacity to conduct product registrations in a timely manner. This makes it difficult for these countries to provide high-quality rapid HIV tests and treatment.

The FDA and the HHS have been working with the Department of State Office of the Global AIDS Coordinator (S/GAC); the World Health Organization; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and other organizations to help countries build both their health care systems and regulatory capacities.

Importantly, FDA has partnered with host country health ministries to help strengthen regulatory capacities in support of their public health programs. PEPFAR recently contributed $1.5 million in support of this FDA partnership to further regulatory system strengthening in the East African community.

With these improvements, countries battling HIV and AIDS can build the systems necessary to ensure that patients get the high-quality treatment they need, which one day will lead to the realization of an AIDS-free generation.

Margaret A.  Hamburg, M.D., is the Commissioner of the Food and Drug Administration

Jimmy Kolker is Assistant Secretary for Global Affairs in the U.S. Department of Health and Human Services

World AIDS Day

By: CDR. Steve L. Morin, R.N., B.S.N.

World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically no hope. They eventually died from the disease early in the epidemic.

In the beginning, World AIDS Day was an important platform for the HIV/AIDS community to help raise awareness among the many people who had never known or even met anyone living with HIV/AIDS. In those early years, the focus was on finding a treatment and keeping those diagnosed with the disease alive. 

Last year marked 30 years since AIDS was first reported in the Center for Disease Control and Prevention’s Mortality and Morbidity Weekly Report (MMWR), emerging as a permanent part of our lives. Today, when I think about World AIDS Day, I think of it as a day to acknowledge how far we have actually come in the fight against HIV/AIDS. We’ve come so far—not only in treatment, but also in preventing new infections, and reducing or eliminating the stigma associated with this disease. 

The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS. I am happy to say that this year there were four major advances in the battle against HIV. 

  • Truvada is the first HIV drug approved for prophylactic (preventive) use. It has been shown to reduce the risk of sexual transmission of the HIV virus to uninfected adults.
  • OraQuick In-Home HIV Test is the first rapid home-use oral HIV test kit that does not require sending a sample to a laboratory for analysis. This test has the potential to identify previously undiagnosed HIV infections, especially if used by those unlikely to visit a doctor’s office or clinic.
  • Stribild is the first HIV medicine to combine four separate drugs and is the third HIV drug that can be taken once daily.
  • The number of antiretroviral drugs tentatively approved or approved for use under the President’s Emergency Program for AIDS Relief, or PEPFAR, has surpassed 150. PEPFAR is a program to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

So today, as World AIDS Days approaches, I ask that you take a moment to remember the combined effort of patients, researchers, industry, FDA and other government agencies contributing to the successes in fighting HIV/AIDS. There are currently 36 approved therapies for treating HIV/AIDS in the United States. As new therapies are added to the list of treatments, patients’ quality of life has improved, with fewer side effects and simpler therapeutic regimens that make adhering to therapy easier. People living with HIV are now able to focus on life rather than death. Until there is a cure, we will continue to work together for an AIDS-free world.

CDR. Steve L. Morin, R.N., B.S.N., is a Health Programs Coordinator in FDA’s Office of Special Health Issues

Our Global Imprint in the Fight Against HIV/AIDS

By Edward Cox, M.D., M.P.H.

Since HIV/AIDS first entered the public consciousness in the 1980s, the biology of the disease has both perplexed and astounded us. Although more than 34 million people live with HIV worldwide, in recent years the disease has also served to unite us in a common goal – the search for a cure.

When I joined FDA more than a decade ago, after having spent time as a fellow at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and in private practice, I could not have imagined the unprecedented level of progress we’d see in the area of drug development for HIV/AIDS. The vast majority of these pivotal breakthroughs have occurred during the last decade and the development programs have often included clinical studies conducted outside of the U.S.

And while our core mission has traditionally focused on protecting the health of Americans while promoting the development of innovative drugs for use here at home, my background as an infectious disease expert allowed me realize early on that FDA would increasingly play an important role in the global public health arena, particularly in areas such as HIV/AIDS, hepatitis C and tuberculosis.

I am particularly proud of our role internationally in supporting the President’s Emergency Plan for AIDS Relief (PEPFAR). Since its inception in 2003, the PEPFAR program continues to serve as a great example of what can be accomplished through collaboration and coordination with our foreign partners.

Since 2004, the agency has worked to ensure that people living with HIV/AIDS worldwide have timely access to safe and effective antiretroviral drugs that have been manufactured by facilities in the U.S. and abroad. As of 2011, FDA has approved more than 137 formulations of drugs and new fixed-dose combination products to treat HIV.

The PEPFAR program itself has directly supported lifesaving antiretroviral treatment for over 3.9 million men, women and children through partnerships with more than 30 countries, including China, Haiti, India, Vietnam and more than a dozen African nations.

And just last week HHS Secretary Kathleen Sebelius and Deborah Autor, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, met with regulatory officials from India and companies with operations in the region to emphasize the importance of continued dialogue on current and emerging public health issues. Among the many topics of discussion was the ongoing need and value of the PEPFAR program.

Today, FDA continues to actively encourage sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination, and co-packaged versions of previously approved antiretroviral therapies. My colleagues in FDA’s Center for Drug Evaluation and Research (CDER) Office of Antimicrobial Products and Office of Generic Drugs stand ready to continue working with companies who are dedicated to providing low-cost therapies to people living with HIV/AIDS around the world.

In December, we commemorated the 23rd anniversary of World AIDS Day and highlighted the 2011 U.S. theme — Leading with Science, Uniting for Action — which Commissioner Hamburg noted was particularly meaningful to FDA given the agency’s role. The success of the PEPFAR program is an excellent example of how science and interaction can quickly translate into meaningful progress for people living with HIV/AIDS.

As a scientist and FDA reviewer, I follow the progress being made when new findings about the disease are released each year. Personally, I can tell you that at FDA we all celebrate the victories that represent progress for patients and express our frustration and disappointment with the setbacks.

While a cure remains elusive for now, we intend to solidify our global imprint by continuing our efforts in support of the PEPFAR program. For our part, FDA will continue encouraging the development of new and effective therapies to treat patients.

More information can be found on “What’s New at FDA in HIV/AIDS.”

Edward Cox is the Director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research