The 22nd Anniversary of World AIDS Day
Remarks by Associate Commissioner Lou Valdez
in Honor of World AIDS Day
U.S. Department of Agriculture – APHIS
December 1, 2010
Good Morning. It is a privilege to address you all in honor of the 22nd Anniversary of World AIDS Day.
First observed in 1988, World AIDS Day was initiated by Ministers of Health from around the world, who called for a spirit of social tolerance and greater awareness of HIV/AIDS on an international scale.
Observing World AIDS Day each year helps us to honor those who have died from, those with live with, and those who care for people with AIDS, and to focus attention on the prevention and treatment of HIV and AIDS-related conditions. With the 2010 Theme of “Act Aware”, we are urging governments to keep the commitments they have made to fight this deadly disease.
Almost 60 million people have been infected with HIV and 25 million have died of HIV-related causes since the beginning of the epidemic. These statistics exemplify AIDS as one of the most destructive and devastating epidemics in recorded history.
Despite recent, improved access to antiretroviral treatment and care in many regions of the world, the AIDS epidemic claimed an estimated 2 million lives in 2007, of which about 270,00 were children. Countries continue to rank AIDS high on the list of the most important issues facing our world, and in many countries, it remains a main cause of illness and death.
The contributions of the U.S. Food and Drug Administration, through its Center for Drug Evaluation and Research (or CDER) have made a tremendous difference in the lives of people living with AIDS through the Approval/Tentative Approval process for the President’s Emergency Plan for AIDS Relief (known as PEPFAR). Part of my reasons to be here today is to celebrate these contributions that exemplify the miracle of FDA’s work.
On the screen, you can see the lives of the people that FDA’s regulatory expertise and contributions touch daily. Please let me give you some context.
There are an estimated 33.4 million people living with HIV globally and 2.7 million newly infected in 2008. Young people – at 15 years or older - account for almost 40 percent of all new adult HIV infections worldwide. In sub-Saharan Africa alone, the epidemic has orphaned more than 14 million children, so we are likely to feel the serious impact of HIV and AIDS for generations to come.
With World AIDS Day we recognize the significant strides the global community has made in the fight against HIV/AIDS over the last 25 years. We also recommit ourselves to overcome the obstacles and challenges that still stand in our way.
On the first World AIDS Day in 1988, AIDS was a quick, painful and terrifying death sentence. Today, thanks in part to the antiretroviral drugs FDA reviews, we are able to mark World AIDS Day as a day of hope.
FDA contributions, through PEPFAR, are truly part of the significant global impact, which increases access to treatment and saves lives. Through its partnerships with more than 30 countries, as of September 30, 2009, PEPFAR directly supported life-saving antiretroviral treatment for over 2.4 million men, women and children. These represent more than half of the estimated four million individuals in low and middle-income countries on treatment.
Launched in 2003, PEPFAR is the largest commitment in history by any nation to combat a single disease and extend lives. The American people have already provided more than $25 billion dollars to the fight against AIDS around the world.
It was in May 2004 that FDA announced its special initiative for PEPFAR to encourage pharmeutical companies to submit marketing applications for ARVs, including single entities, fixed-dose combinations and co-packaged drugs, and for FDA to expedite their review.
FDA’s CDER would use its well-established generic drugs “tentative approval” process to help ensure the clinical safety and efficacy and the manufacturing quality of ARVs that were to be purchased with PEPFAR dollars. These applications, which undergo the thoroughness of the FDA scientific review and inspection processes, provide a confidence in the safety and efficacy of those drugs to many governments and organizations purchasing, and thus increase access to needed treatment regimens around the globe.
Although we call the authorizations a “tentative approval” in the FDA regulations, there is nothing “tentative” about FDA’s perspective on its decision or the thoroughness of the scientific review and inspection these marketing applications undergo.
For a product to receive a “tentative” approval, it must be found by FDA to meet all of the clinical safety and efficacy standards and all of the manufacturing quality standards for marketing the product in the United States.
Were it not for patents blocking the marketing of these products in this country, they would have been given full approval authorizations for marketing in the United States.
In October 2009, FDA marked the anniversary of the approval of the 100th ARV product authorization in association with PEPFAR. This was an important milestone for the Agency.
Simply put, this success reflects collaboration, partnership and public health at its best.
We celebrated this milestone achievement at an event co-hosted by the Pan American Health Organization and the Office of the Global AIDS Coordinator. The FDA Commissioner, Dr. Peggy Hamburg; the President’s Global AIDS Coordinator, Ambassador Eric Goosby; and Ambassadors from African and Latin American countries joined our celebration. Dr. Margaret Chan, the Director General of the World Health Organization, participated via video from Geneva.
As we recognized the 100th product authorized in association with this program, the Partnership for Supply Chain Management has estimated that FDA’s actions are saving the PEPFAR drugs budget an average of $176 million annually based on a four year period. And this estimate doesn’t include the potential savings by other PEPFAR partners. These savings can then be used in other program areas to treat, prevent and care for more patients and save more lives.
The success of this program also reflects the generosity and commitment of a cadre of FDA scientists, regulatory and technical experts, primarily at our Center for Drug Evaluation and Research, but also in our Office of Regulatory Affairs and Office of International Programs.
Especially significant in the anniversary of the 100th drug approval application was that 29 have been new products, and twenty-two of these new products were new combinations or complete regimens that have not previously been authorized in the United States.
Since the anniversary, CDER has continued to make progress. To date, FDA has approved 121 original applications – both new drug applications and abbreviated new drug applications (known as NDAs and ANDAs). For new drug applications, CDER has taken action on 40 (39 TA & 1 A), including
• 14 triple-drug fixed-dose combinations (including 2 pediatric formulations) • 20 double-drug fixed-dose combinations (of these 8 are co-packaged with a third drug for adults, and 3 pediatric formulations), and • 6 single-drug pediatric tablet formulations
CDER’s Office of Generic Drugs has taken action on 81 abbreviated new drug applications or ANDAs, mostly for single formulations.
And FDA’s work doesn’t stop at NDAs and ANDAs original reviews. There have been a number of manufacturing and labeling changes for original applications (NDAs & ANDAs) submitted after the first regulatory action requiring FDA review.
FDA’s work however is larger than application review. It also reflects our collaboration with the World Health Organization. We have worked primarily with WHO’s Pre-qualification Program so that FDA’s assessment of these marketing applications for ARV drug formulations and fixed-dose combinations is used to add new products to its Drug Pre-qualification List without WHO having to expend significant further resources on their assessment.
In this way, WHO resources can be used to assess products that are not submitted in association with the PEPFAR program. We remain committed to working closely with the WHO to and explore opportunities for new and different support of its pre-qualification and other programs.
FDA has also worked closely with national drug regulatory authorities with PEPFAR partner countries to assist rapid national authorization in a country.
Many of these government regulators have been brought to the FDA for targeted training in assessment of marketing dossiers and product development oversight.
We have also worked closely with the manufacturing firms submitting applications. FDA has worked with the manufacturers to assure that their marketing applications were complete and high quality, and that they were ready for the rigors of an FDA inspection of their clinical trials sites and of an FDA inspection of their manufacturing processes.
Thus on many levels, FDA’s regulatory reviews have contributed to significant savings to the cost of drugs, and increased access of safe and affordable drugs to many in need.
The manufacture and export of generic drugs was not only a turning point in terms of the price of ARVs, but also helped to revolutionize treatment for resource-poor settings by simplifying HIV/AIDS treatment. Fixed-dose combinations and co-packaged products were a significant innovation as they reduce the number of pills taken each day because they can be used as complete regimens and some of them can be dispersed in water for children who are not able to swallow tablets.
Because these innovative drug products are easier to manage – for both patients and health workers – they increase adherence, thereby reducing the incidence of drug resistance. The drugs are also available in heat resistant forms, which proved extremely valuable for use in the developing world, where often there is scarce access to refrigeration facilities.
Generic antiretrovirals are now widely used to treat HIV/AIDS in the developing world. They have been integrated into many treatment programs including PEPFAR. PEPFAR, as the single greatest supporter of treatment provision for AIDS in the developing world, began to distribute generic drugs through its programs in the 2004-2005 period. In 2007, generics accounted for 57 percent of the 131 million dollars PEPFAR spent on AIDS drugs.
I’ll turn back now to the FDA. CDER scientific contributions have been and remain an essential element in allowing the American people to respond with compassion and the rigor of public health to the global AIDS epidemic.
This work of CDER is not easy, and the Program has certainly expanded significantly past any of our initial expectations. Many times, this work is in addition to already very full portfolios. Yet I think I can safely say on behalf of CDER scientists and reviewers, they are incredibly proud to contribute through the Tentative Approval/Approval Program under PEFPAR.
Through these efforts, FDA has touched the lives of many. We look at these photos of persons living with AIDS and their families and can feel that sense of hope. We are proud to be part of this global public health effort.