Monthly Archives: July 2012

FDA Voice Interviews Michelle Yeboah, Dr.P.H., Director of FDA’s Office of Minority Health

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FDA Voice: Dr. Yeboah, thank you for blogging with FDA Voice today. Can you tell us about your job at FDA, and give us some background on the origin and scope of FDA’s Office of Minority Health?

Dr. Yeboah: Absolutely! The FDA Office of Minority Health (OMH) was established in 2010, as mandated by the Affordable Care Act. OMH serves as the principal advisor to Commissioner Hamburg on minority health and health disparities. I’m currently the Acting Director, and have been on board since the inception of the Office.

FDA Voice: What is the mission or vision for the office, and how did you develop it?

Dr. Yeboah: Our regulatory mission is to reduce racial and ethnic health disparities and achieve the highest standard of health for all. In doing so, we focus on three key areas:

1) Strengthening FDA’s capacity to address minority health and health disparities through coordinated leadership on regulatory actions and decision making across the agency.

2) Promoting effective communication and the dissemination of information to the public, particularly underserved, vulnerable populations.

3) Improving and strengthening the research and evaluation of sub-population data associations with race and ethnicity.

This mission for OMH was developed after discussions with health professional groups, academicians, advocacy groups, industry and a cadre of leaders in the area of minority health.

FDA Voice:  Can you tell us more about your initiatives to improve FDA’s ability to address minority health and health disparities among racial and ethnic populations?

Dr. Yeboah: OMH explores the intersection between regulatory science and health disparities. The 2010 US Census estimates that minorities account for 46% of the overall US population, and current health statistics highlight poorer health outcomes for African American, American Indian and Alaska Native, Asian American, Hispanic American, Native Hawaiian and Pacific Islander communities. Across racial and ethnic groups, a disproportionate share of  minority communities are more likely to die from serious health issues such as diabetes, heart disease, cancer and asthma, to name a few.

The scientific need for understanding health disparities through scientific research is critical to eliminating health inequities and ensuring the highest standard of health for all.

As highlighted in FDA’s Strategic Priorities 2011-2015, expanding efforts to meet the needs of special populations is a crosscutting agency priority. Strengthening FDA’s capacity to understand the complexities associated with minority health and health disparities can lead to better health outcomes for the most vulnerable communities, whether it is through epigenomics, personalized medicine or targeted risk communication among underserved populations.

In May we held a Webinar entitled Steps to Addressing Health Disparities. The Webinar discussed the establishment of the Office of Minority Health at FDA and also discussed agency efforts to ensure the safety, efficacy, and security of regulated products among vulnerable populations.

FDA Voice:  We’d love to hear about the initiatives and partnerships you are working on to address health disparities. I know there are a lot of them, but if you could give us some details that would be great!

Dr. Yeboah: Yes – as we talked about, OMH is looking to find opportunities for collaborating in the areas related to minority health, health disparities and issues of personalized medicine. So far this year we have been able to finalize four University-based research partnerships:

  • University of Hawaii Hilo, College of Pharmacy
  • Meharry Medical College, Center for AIDS Health Disparities Research
  • University of Nebraska, Rural Health Education Network
  • University Of Hawaii Manoa, Office of Public Health Studies

These partnerships are solely focused on examining minority health and health disparities from a regulatory perspective.  For example, we have a research Memoranda of Understanding (MOU) with the University of Hawaii, Hilo College of Pharmacy, to work on reducing disparities in diabetes treatment and outcomes among Asian and Pacific Islander Americans living in Hawaii. And, to date, we have established partnerships with several Universities exploring issues of disparities in diabetes, tobacco and HIV/AIDS.

We have additional University-based research partnerships that are pending and have several collaborations with other organizations including the National Institutes of Health, with whom we are co-sponsoring the 2012 Summit on the Science of Eliminating Health Disparities: Building a Healthier Society, Integrating Science, Policy and Practice, in the fall. We are also partnering with the Centers for Disease Control and National Hispanic Alliance. We look forward to growing additional partnerships to address issues of health disparities from a regulatory perspective.

Find out the details on our MOU’s. We have a lot of exciting and promising activities on the horizon at OMH!

FDA Voice:  How is the Office of Minority Health helping to diversify the FDA Advisory Committees?

Dr. Yeboah: Last year OMH began a new initiative called “Enhancing Diversity on FDA Advisory Committees.” The goal is to broaden the search for qualified advisory committee candidates who have experience with underserved communities.

Advisory committees are essential in supporting FDA’s mission of protecting and promoting the public health by obtaining independent expert advice on scientific, technical, and policy matters. Promoting FDA’s leadership role in addressing health disparities and assuring diverse perspectives on advisory committees are integral to achieving the agency’s public health mission.

The expertise provided by advisory committee members is essential for understanding the safety and efficacy of regulated products on the target population, especially racial and ethnic populations, who are often disproportionately impacted by higher rates of disease, disability and premature death for conditions ranging from cancer to cardiovascular disease and HIV/AIDS to name a few.

It is critical that FDA Advisory Committee members have the expertise and experience necessary to effectively consider the impact of regulated products on racial and ethnic populations. Health professionals from racial and ethnic minority groups or who serve in minority communities often possess valuable experience in the prevention, diagnosis and treatment of disease among racial and ethnic minorities.

FDA Voice:  I understand the Office of Minority Health is also helping to strengthen research with clinical trials. Can you talk about that a bit?

Dr. Yeboah: We collaborated with FDA’s Office of Women’s Health, the Society for Women’s Health Research, and industry representatives, and held the “Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities” conference late last year to explore promising practices in clinical trials for the inclusion of women and minority populations. The meeting drew a cadre of professionals from various fields including pharmaceutical industry representatives, health care providers, patient advocacy groups and academia.

OMH continues to pursue the overarching goals discussed at the conference: to increase the participation of underserved populations in clinical trials with resulting improvement in clinical care and positive health outcomes, and to share successful practices in the recruitment, retention and analysis of women and minorities in clinical trials. For additional information about the conference or our office please visit the OMH Webpage.

Michelle Yeboah, Dr.P.H., is Director of FDA’s Office of Minority Health (Acting)

New Weight-loss Drugs Offer Promise in the Fight Against Obesity, But They’re Not for Everyone

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By: Eric Colman, M.D.

More than one-third of the adult U.S. population is obese, a proportion that has risen dramatically in the last three decades. With FDA’s recent approval of two new prescription weight loss drugs, marketed under the trade names Belviq and Qsymia, the outlook for successful drug therapies to fight our nation’s growing obesity epidemic has improved. Before these two approvals, there had not been a new weight loss drug approved by FDA in more than 13 years.

In clinical testing prior to approval, compared with lifestyle modification alone, patients treated with Belviq plus lifestyle modification had an average weight loss of about 3.5% and patients treated with Qsymia plus lifestyle modification averaged weight loss of approximately 6% to 9%. Although these results are a step in the right direction, there are a few important things to keep in mind about these products.

First, if you’re looking to lose a few pounds before going to the beach or after over- indulging on vacation, these drugs are not for you. They are not even intended for use by otherwise healthy people who are significantly overweight. Both are only intended for use in people who are obese, defined as having a body mass index (BMI) over 30, or for certain overweight patients who are not obese but have a significant health problem like diabetes, high blood pressure, or high cholesterol.

These new products have received a great deal of media attention, but one aspect of their use not highlighted by the media is that these drugs are intended for chronic use as part of a comprehensive weight loss program that includes modifications to diet and increased exercise. Obesity is a chronic disease, similar to diabetes or high blood pressure, and requires long-term treatment to help patients avoid regaining weight once a treatment program is stopped. Some patients may require long-term use of a weight loss drug in order to achieve and sustain a healthy body weight, which can be associated with significant improvements in co-morbid conditions such as diabetes and hypertension.

Another point to keep in mind is that Belviq and Qsymia are both associated with potentially serious risks, which is a key reason why they are approved by FDA only for use in obese patients whose risk from the health consequences of obesity and its related health issues outweigh the risks associated with using the drug. For instance, among other adverse effects, Qsymia can cause birth defects and Belviq can cause a dangerous chemical imbalance called “serotonin syndrome.” Doctors and patients who are considering the use of these drugs as part of an individualized weight management program must carefully consider the potential benefits and the potential risks and carefully follow the label instructions for how to use these drugs safely and effectively, including stopping use of the drugs if weight loss is not achieved.

After 13 years without a new weight loss drug on the market, Belviq and Qsymia represent new hope for many who have been struggling with obesity, and will be valuable tools in their efforts to overcome the condition. Finally, however, what may be most important to remember about these two new products is that they are not “cures” for obesity. A balanced diet, exercise and other healthy lifestyle choices will remain critical components of successfully achieving and maintaining a healthy weight.

Eric Colman, M.D., is Deputy Director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research

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

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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


Quick Look at FDA’s Mexico Post and Our Global Work

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By Phyllis J. Marquitz, M.Sc., J.D.

En Español

Food is something that we all have in common. It brings people together across cultures, borders and tables. Today, about 49 percent of fresh fruits, 21 percent of fresh vegetables and 85 percent of seafood eaten in the United States are imported. Many of these products originate from Mexico, and the volume of imported goods is increasing.

Plate of musselsIndeed, Mexico ranks second only to Canada as the largest agricultural trading partner with the United States with bilateral trade of over $20 billion, according to the U.S. Department of Agriculture. The ever-increasing imports of food are reshaping the way FDA does business, and the task of ensuring that food is safe and of high quality for American consumers no longer begins or ends at the border.

One important step FDA has taken to ensure the quality of food is to move some of our operations beyond our borders, opening 13 offices in other parts of the world since 2009. The office in Mexico opened in 2010 and is located in the capital, Mexico City, the largest city and most important cultural, educational and financial center.  Our five-person office, which includes one other FDA staffer plus three local employees, is part of the agency’s regional Latin American Office, with posts in Costa Rica and Chile.

Part of what we do is educate industry groups and academia about FDA’s public health regulations so that firms will have the tools they need to implement preventive measures that will help ensure that products are safe throughout the supply chain. In this year alone, our Mexico City office organized 20 outreach events that drew over 1,000 representatives from industry, universities and local governments.

A key part of our job is to help implement existing international arrangements between the United States and Mexico and other foreign governments. These arrangements facilitate and help ensure high quality standards we expect and insist on before any food, drug, or other health care product can be imported into the United States.

To help maintain preventive controls and science-based standards and enable swift regulatory action, we conduct outreach activities, translate documents and exchange strategic, scientific, and regulatory information routinely with our Mexican counterparts. They include the Mexican Federal Commission for Protection for Sanitary Risks, known as COFEPRIS. A recent example was the case of a non-compliant dietary supplement that contained active pharmaceutical ingredients. COFEPRIS acted on FDA’s information by conducting its own product analysis and stopped manufacturing of a product that might otherwise have entered the United States.

We’ve also sponsored pilot projects with Mexican counterparts to increase our knowledge base around the inspection systems in both countries. We need to know specifically how preventative systems work in day-to-day production and how Mexico enforces its regulations to ensure product safety and quality. 

Partnerships with regulatory counterparts are also part of FDA’s efforts to protect public health. An example is an FDA Statement of Cooperation with COFEPRIS, signed in June 2012. This arrangement demonstrates a strong commitment at all levels of the U.S. and Mexican Governments to work together on food safety under a recent Food Safety Cooperative Arrangement, signed by the U.S. Secretaries of USDA and the Department of Health and Human Services (FDA’s parent department) and their Mexican counterparts in May 2012 in Geneva, Switzerland. 

With the FDA-COFEPRIS arrangement, FDA recognizes that COFEPRIS, through the Mexican Shellfish Sanitation Program (MSSP), has an effective molluscan shellfish sanitary control system in place. FDA and COFEPRIS will oversee continued compliance with the U.S. National Shellfish Sanitation Program requirements through jointly conducted audits of the MSSP. These audits include checking water quality and production standards at the source. 

FDA continues to work with its international counterparts and partners to help ensure that safe, nutritious food is produced world-wide – before it is made available to U.S. consumers.

Phyllis Marquitz, is Assistant Regional Director for Latin America (Mexico City) within FDA’s Office of International Programs, Office of Global Regulatory Operations and Policy

Enhancing the Global Food Supply by Building International Capacity

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By: Julie Moss

In a global marketplace, food must be safe regardless of where it comes from. That means consumers should feel confident in the safety of the food they eat, whether it comes from India or Indiana. In fact, the distinction between imported and domestically produced food is blurring, as many U.S. food products are made with imported ingredients. Responding to this increasingly globalized food supply system, FDA held a public meeting on June 19 to discuss FDA’s plan to expand the food safety capacity of foreign governments and their respective food industries in countries that export food to the United States. This approach is known as capacity building.

microphoneCongress recognized the need for capacity building in the Food Safety Modernization Act (FSMA), of 2011 when they tasked FDA with developing a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the U.S. FSMA marks the first time that Congress has charged FDA with comprehensively addressing international food safety capacity building, a development that has been very exciting for FDA. I have the pleasure of co-leading the work group to develop the plan with Katherine Bond, who is with FDA’s Office of International Programs.

Although the specific charge provided by Congress is new, this type of work is not. FDA has been engaged in international capacity building for many years, traveling overseas to conduct food safety training programs on Good Agricultural Practices, Good Aquaculture Practices and to provide hands-on laboratory training, for example. But the international capacity-building plan mandated by FSMA allows us to take this work to a new level.

Of course, food safety capacity building isn’t just about strengthening foreign food safety systems—we build capacity domestically as well. For example, FDA provides grants to organizations that represent State and local laboratories to strengthen laboratory collaboration and equivalency. FDA has also participated in several public-private collaborations to provide food safety training here in the U.S.

The June 19th meeting gave the public an opportunity to view and comment on draft recommendations that we’re considering for inclusion in the capacity-building plan. A number of organizations provided input on the recommendations, including the Grocery Manufacturers Association, the U.S. Department of Agriculture’s Foreign Agricultural Service, the World Bank, the United Nations, the governments of Canada and the Philippines, the U.S. Agency for International Development, the Center for Science in the Public Interest, and Campbell Soup. Given the breadth of this input, it is essential that FDA collaborate with partners to get the work done. FDA can’t do it alone.

FSMA requires that we include, as appropriate, certain elements in developing the plan—such as provisions for bilateral and multilateral arrangements and agreements, secure electronic data sharing, and training on U.S. requirements for safe food. But we aren’t stopping there. We are also considering incorporating additional themes into the plan to ensure that FDA performs its work effectively and intelligently. This means using available data to determine where the need is the greatest by country and by commodity, and it means being able to measure the impact of our efforts.

FDA’s international capacity-building plan is still under development, and your input is most welcome. You can review a summary of our draft recommendations, and comments are due to FDA’s Division of Dockets Management by July 20, 2012.

Julie Moss is Deputy Director, International Affairs Staff, of FDA’s Center for Food Safety and Applied Nutrition