Supporting Africa’s Capacity to Review and Approve HIV/AIDS Drugs

Posted on January 29, 2013 by FDA Voice

By: Beverly Corey, DVM

Sub-Saharan Africa, the portion of Africa that runs from the Sahara Desert to the Cape of Good Hope at Africa’s southern tip, is more heavily affected by HIV and AIDS than is any other region of the world. In South Africa alone, 17.8 percent of the people have HIV. There were an estimated 22.9 million people living with HIV and 1.2 million deaths in Sub-Saharan Africa in 2010.

Against the backdrop of this harsh reality, FDA has played a critical role in helping to ensure the availability of high quality, safe, and effective treatment therapies. The agency has approved or tentatively approved applications for 155 antiretroviral drugs from Dec.3, 2004 to Nov. 8, 2012, thereby making them available for use as part of the President’s Emergency Plan for AIDS Relief, or PEPFAR. This program, begun in 2004, is the U.S.government’s commitment to support HIV/AIDS treatment for millions of people around the world.

It is clear that the supply of medications to treat HIV/AIDS in Africa must be increased. One necessary way to address delayed access to medications is to bolster the expertise of African regulators so that they can conduct timely reviews of drug applications. After all, the FDA approval or tentative approval is just one step. Then the therapies must be registered (or approved) by competent drug regulatory authorities in the countries of use.

Some resource-constrained low and middle income African countries have lacked sufficient expertise to conduct registrations efficiently. Focusing on generic drugs will be particularly important there, because generics are less expensive than the brand name products.

Recently, as part of a longstanding PEPFAR mandate for FDA to provide drug registration training for African regulators, the agency had the opportunity to spearhead and provide such training.

Let me share with you what we accomplished. FDA, in collaboration with the Kilimanjaro School of Pharmacy and Purdue and Howard universities, provided a five-day course on the review of generic drug applications and PEPFAR drug reviews.

Thirty-seven regulators and academicians from 17 African countries participated. This first-of-its-kind training, held in Moshi, Tanzania, was aimed at enabling regulators and pharmaceutical school faculty to familiarize themselves with regulatory and scientific methods applied by FDA.

The most exciting, complementary aspect of the training was to introduce the value of integrating regulatory science training into the curricula of schools of pharmacy and other academic institutions in Africa.

FDA and its partners believe that this training course can eventually be turned into a teaching module for use in academic curricula throughout Africa. Such curricula can support a cadre of regulatory affairs professionals to work in government agencies. This would further the availability and the manufacture of quality, safe and effective drug products for the African population.

If we can contribute to a global curricula for regulators, what a legacy that would be, for both PEPFAR and FDA!

Beverly Corey, DVM, is the Senior Regional Advisor for Sub-Saharan Africa, FDA Office of International Programs, US Embassy, Pretoria, South Africa

FDA is Proud to Have Helped PEPFAR Reach its Latest Milestone: More than 150 Drugs Now Available Worldwide to Help Treat HIV/AIDS

Posted on July 27, 2012 by FDA_Voice

By: Jeffrey S. Murray, M.D.

While Americans today are all too familiar with the acronyms “HIV” and “AIDS,” many of us are not familiar with the strange-sounding acronym, “PEPFAR.” Despite being less well-known than these other acronyms, PEPFAR, which stands for the President’s Emergency Plan for AIDS Relief, has saved about 1.2 million lives in its global efforts to battle the HIV/AIDS epidemic. This month marks a historic milestone: As of July, 2012, PEPFAR has now made available more than 150 drugs to help treat people worldwide infected with HIV.

Access to life-saving HIV/AIDS therapy is one of many goals of the PEPFAR program, the U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world. Since PEPFAR’s establishment in 2003, the HIV/AIDS drug program has supported life-saving treatment for more than 3.9 million adults and children worldwide.

FDA is proud to play a role in contributing to PEPFAR’s success. As part of PEPFAR’s program, FDA conducts an expedited review of antiretroviral drugs produced by manufacturers all over the world and ensures that these products are rapidly reviewed, their quality assessed, and that they are acceptable for purchase with PEPFAR-supported funds.

In 2004, to help increase the availability of safe and effective HIV/AIDS drugs for use under PEPFAR, FDA began an expedited review process for generic HIV/AIDS drugs. This process respects the patent and exclusivity rights of brand name HIV/AIDS therapies in the U.S., but helps ensure that safe and effective lower-cost generic versions of these therapies can be purchased under PEPFAR for use in other countries. The PEPFAR program reaches 15 of the hardest hit countries in Africa, Asia, and the Caribbean. By the end of 2007 more than 90 percent of HIV/AIDS drug products provided in eleven of these countries were generic.

As a result of this expanded use of generic products under PEPFAR, the overall cost of providing treatment has been substantially reduced. For instance, in one PEPFAR-assisted country it once cost $10,000 per person each year for a typical treatment regimen. That cost is now less than $200 a year. Such cost savings have likely helped millions more people receive HIV/AIDS therapy who otherwise would not have access to this treatment.

The goal of PEPFAR is to work with host nations to support treatment of at least 3 million people, prevention of 12 million new infections, and to provide care for more than 12 million HIV-infected and affected people by 2013. In addition, PEPFAR will support training of at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.

With PEPFAR reaching its historic milestone of making more than 150 drugs available to help fight HIV/AIDS, FDA applauds the program’s efforts, its dedicated workers, and all of PEPFAR’s international partners for their life-saving work.

Jeffrey S. Murray, M.D, is Deputy Director in the Division of Antiviral Products at FDA’s Center for Drug Evaluation and Research

Our Global Imprint in the Fight Against HIV/AIDS

Posted on January 9, 2012 by FDA_Voice

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 23^rd 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