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 Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

Posted on January 22, 2013 by FDA Voice

By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21^st century and consider the critical functions of regulatory science and systems that contribute to improved public health.

Participating thought leaders have included:

Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
Margaret Chan, M.D., Director-General of the World Health Organization
Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets.

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

FDA and Sub-Saharan Partners Protecting Public Health

Posted on January 18, 2013 by FDA Voice

By: Beverly Corey, DVM

FDA and its partners in Sub-Saharan Africa have made great strides in improving the oversight of the clinical trials of medical products in development—an important advance in protecting public health in both the U.S. and Africa.

This is important not only to protect the Africans who are participating in these tests of medical products, but also because the FDA and other regulatory authorities must rely on the results of these studies when reviewing marketing applications for the products.

FDA’s Office of International Programs (OIP) established its Sub-Saharan Africa Post in Pretoria, South Africa, in June 2011. We have been building regional relationships that allow us to share information about FDA policies and procedures, and to better understand the regulatory landscape there. The latter is no small feat in this vast region of 54 countries with varying degrees of regulatory strengths and capabilities.

However, our collaboration with the Southern Africa Development Community (SADC), which represents 15 African nations, has allowed FDA to strategically engage in strengthening regulatory capacity in the area of Good Clinical Practices (GCPs) and clinical trial inspections. These practices, and the inspections to ensure that they are followed, are designed to protect the integrity of data produced by the trial and the safety of its participants.

This activity has given expertise to regulators who did not think their knowledge base was extensive enough to audit (monitor) and inspect clinical trials. Regulators in countries that once did not audit clinical trials are now doing so. With more than 2,000 clinical trials being conducted in Africa—over half of them in South Africa—this is a momentous public health achievement.

GCP team members meet with the principal investigator and staff at a TB clinical trial site

The Sub-Saharan Africa Post conducted a successful FDA/SADC Good Clinical Practice Inspection training from August 24-28, 2012, in Lusaka, Zambia. Thirty six drug regulators from 13 SADC countries participated, including Angola, Botswana, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe.

This was the third in an FDA training series—typically offered in three to four phases—to develop trainers who have expertise in clinical practices and inspection. These individuals will also be prepared to train others within their agencies and the regulated community.

This particular workshop was designed to reinforce lessons learned and provide additional inspectional experience for those who completed workshops in the first two training phases in Botswana in 2010 and in Pretoria in 2011. The goals of Phase 3 include reviewing core knowledge and skills, preparing inspection reports and inspectional observations; acquiring additional mock inspection experience at clinical investigator sites; gaining experience with new types of study protocols; and promoting regional networking.

These countries continue to make substantial progress in the oversight of clinical trials. For example, at the onset of our first training, only three of 13 participating countries were involved in how clinical trials are conducted. We now have an additional two countries conducting oversight, with others poised to start soon. Other milestones from our training include important advances towards systematic oversight in Botswana, Mauritius, Swaziland, Tanzania, Zambia and Zimbabwe.

The definitive winner here is public health, both the health of the African people who participate in the trials and the health of the patients who may one day be taking these drugs being studied.

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

FDA’s Special Role: Ensuring Food Safety at the Inauguration

Posted on January 17, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

With the presidential inauguration just days away, it’s an exciting time to be in Washington, D.C. The police are setting up parade routes and security. Hotels and restaurants are bracing for crowds.

And the FDA is playing an important part as well. For certain events of national significance, such as U.S.-based Olympic games, national political conventions and U.S.-hosted summits of world leaders, we are called upon to marshal our expertise. This week, at the request of the U.S. Secret Service and D.C. Department of Health, we’ve assembled a team of 35 FDA staff from across the U.S. including 18 experts in retail foods and field inspection. Their mission? To work closely with the D.C. Department of Health, local county health departments in Maryland and Virginia, and the FDA Baltimore District Office to make sure that the food served at the inaugural ceremony and parade, balls and galas is safe to eat.

When you think about it, it’s not such an unusual role for FDA. After all, the agency works hand-in-hand each day with state and local public health agencies throughout the U.S. to ensure food safety.

And that’s what we’ll be doing this week. Our team of regional food experts will work with local health departments to protect food from contamination. We’ll review menus and observe food preparation, storage and service. We’ll train kitchen staff about risk factors, such as cleanliness, food temperatures and refrigeration. And information on food sources and supply chains at venues and vendors will be questioned so that if any foodborne illness is reported, we’ll have data to trace it back to the source.

2009 inaugural salads

Data from the 2009 inauguration tells us that our inspections covered more than 100,000 meals. We expect similar coverage this time around.

It’s a privilege and an honor, but it’s also an enormous responsibility. Fortunately, we come prepared. We tackle this important challenge armed with years of valuable knowledge and experience in careful, data-based, cutting-edge science. We protect Americans from foodborne illness based on lessons learned over a long period of time.

In ancient Rome, the emperors had special food tasters to make sure their feasts were safe and poison-free. Washington, D.C., isn’t ancient Rome, of course, and the “poisons” we are looking out for may be dangerous microbes.

But just as the Secret Service is responsible for overall security at the inaugural events, FDA is responsible for managing food safety and security in the retail food venues. We’ll work with the chefs and food services and facilities staff in D.C. to ensure that food safety standards are met. As the FDA Food Safety Modernization Act makes clear, our focus will be on preventing food safety problems before they happen.

The standards that FDA and our local health departments will be enforcing in the nation’s capital are the same as those we have in place every day for you and your families. Whether the lucky guests are at an inaugural ball or eating at a stand along the parade route, they can rest assured – as can you - that the regulations are the same for both, and that FDA is doing its part to help ensure that the food we all eat will be safe.

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

Flu Vaccines Still Available; Supplies Being Monitored

Posted on January 14, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

There is still time to get an influenza vaccine that could protect you during the remainder of the 2012-2013 flu season.

FDA has approved influenza vaccines from seven manufacturers, and collectively they have produced an estimated 135 million doses of this season’s flu vaccine for the U.S. So far, more than 128 million of those doses have been distributed, though not all of those doses have been administered yet, according to our sister agency, the Centers for Disease Control and Prevention (CDC).

We have received reports that some consumers have found spot shortages of the vaccine. We are monitoring this situation and will update you at our Website and at www.flu.gov.

Consumers who are planning to be vaccinated can visit the latter site, click on “Flu Vaccine Finder,” enter their zip code and find a list of the clinics, supermarkets, pharmacies and other vaccine providers in their neighborhoods. Before you go, it’s wise to call ahead to confirm availability.

Health care providers can also search for vaccine by using the Influenza Vaccine Availability Tracking System (or IVATS), which is available online at http://www.preventinfluenza.org/ivats/ivats_healthcare.asp.

If you already have the flu, be assured that FDA is working to make sure that medicine to treat flu symptoms is available for all who need it. We do anticipate intermittent, temporary shortages of the oral suspension form of Tamiflu—the liquid version often prescribed for children—for the remainder of the flu season. However, FDA is working with the manufacturer to increase supply and reminding health care professionals that FDA-approved instructions on the label provide directions for pharmacists on how to compound a liquid form of Tamiflu from Tamiflu capsules.

Any Tamiflu shortages should be reported to FDA’s Center for Drug Evaluation and Research at drugshortages@fda.hhs.gov.

The flu season usually peaks in January or February, but can extend as late as May. CDC recommends that all adults and children who are at least 6 months old receive a flu vaccine each year, with fall being the optimal time to get it. It takes about two weeks for the vaccine to “kick in,” meaning the time it takes for your body to develop an immune response to provide protection from the flu.

Although the last year’s flu season was relatively mild, this season is turning out to be more severe. On the positive side, the vaccine is well matched this season to the circulating virus strains that are causing influenza. FDA’s preparations for this flu season began last year. In February, working with the World Health Organization and CDC to review influenza disease surveillance and laboratory data, and with the input of our advisory committee, FDA selected the influenza strains for the vaccine that is currently being used in the U.S.

So if you haven’t been already, get vaccinated. And mark your calendars for next fall; plans for the 2013/2014 flu season and the vaccine that will fight it are already underway.

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

Basing Food Safety Standards on Science and Prevention

Posted on January 8, 2013 by FDA Voice

By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination.

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21^st century.

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

FDA Commemorates 30th Anniversary of the Orphan Drug Act

Posted on January 7, 2013 by FDA Voice

By: Gayatri R. Rao, M.D., J.D.

When President Reagan signed the Orphan Drug Act 30 years ago, he enacted a critically important piece of health care legislation. The passage of this Act on January 4, 1983, was monumental because it created—for the first time—incentives to develop desperately needed medical products for Americans suffering with rare diseases. Until that point, development of such products was very limited. For instance, in the decade leading up to the passage of the Orphan Drug Act, only 10 industry-supported products for rare diseases were brought to market.

The Office of Orphan Products Development (OOPD) was formed at FDA more than 30 years ago, prior to the passage of the Orphan Drug Act, because FDA recognized that rare diseases, when taken together, posed a significant national public health issue. Once the Orphan Drug Act was passed, OOPD became responsible for administering the incentive programs created to spur the development of medical products for rare diseases, namely the Orphan Drug Designation Program and the Orphan Products Grants Program. These products include drugs, biologics, medical devices, and medical foods for the treatment of rare diseases.

As FDA commemorates the passage of this important legislation, we look back over the last 30 years with pride. Since its passage, over 2700 products in development have been designated as orphan drugs through the Orphan Drug Designation Program and over $290 million has been awarded to clinical studies through the Orphan Products Grants Program. These programs, along with the critical, collective efforts of the Center for Drug Evaluation and Research’s (CDER) Rare Diseases Program, and those of many individuals across FDA, have helped to bring over 400 orphan products for rare diseases to the market.

We also commemorate the more than 30 years of dedicated service from every member of the rare disease community:

the patient advocates, who spurred national awareness about the challenges that people with rare diseases face and who continue to support families, educate the community, and drive research into their diseases;
the legislators who heard the voices of rare disease advocates and worked to champion the passage of the Orphan Drug Act;
the research community, which continues to leverage resources and foster collaborations among academia and industry stakeholders;
the clinicians, who support the medical needs of families with rare diseases and work to advocate on behalf of the community;
and industry, including pharmaceutical and biotech companies, angel investors, and venture capitalists who, in the spirit of the Orphan Drug Act, have come together to develop products for rare diseases.

Our many successes give us a reason to celebrate 30 years of hard work to provide diagnostic or treatment options to those with rare diseases. But we are keenly aware that there is still a challenging road ahead. We at FDA remain firmly committed to working with the rare disease community to tackle those challenges and to find new diagnostic tools and treatments for the millions of patients with rare diseases.

Gayatri R. Rao, M.D., J.D., is Director for The Office of Orphan Products Development