Kim Lufkin

The Institute of Medicine (IOM) yesterday released a new report that stresses the importance of bolstering regulatory systems abroad in order to improve the safety and quality of medical products circulating around the globe. According to the report, many low- and middle-income countries do not have sufficient regulatory capacity, which limits their ability to oversee medical products such as drugs and vaccines. The report emphasizes that strengthening regulatory systems in these nations is critical for the health of Americans—indeed, more than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs in the United States actually come from overseas. US Food and Drug Administration (FDA) Commissioner Margaret Hamburg stressed this point recently when talking about why Americans should care about global health issues. In addition to securing the safety of the drugs and health products that Americans take, we at the GHTC believe that improving regulatory capacity overseas can have vast benefits for millions around the world. Strong regulatory systems can help guarantee that the safest and most appropriate products are available to populations in need, whether it be drugs to treat more well-known conditions like heart disease, or treatments for lesser-known but hugely devastating diseases like sleeping sickness and hookworm. Improved regulatory capacity in countries with neglected disease epidemics can also help monitor and oversee the safety of clinical trials for desperately needed new health tools. Improving regulatory capacity overseas can have vast benefits for millions around the world. Photo credit: PATH Fortunately, this new IOM report presents 13 steps that the FDA and other organizations can take over the next three to five years to bolster regulatory systems in developing nations. In addition to the FDA, other partners include other federal agencies, international stakeholders like the World Health Organization, private industry, and regulatory authorities in developing countries. For example, the report recommends that the FDA and other federal agencies—including the US Agency for International Development and Centers for Disease Control and Prevention—provide technical expertise, training, and tools to strengthen regulatory systems in developing countries. During the report launch event at the National Press Club, committee member Tom Bollyky from the Council on Foreign Relations said that the FDA and other regulatory stakeholders should build an international community to facilitate this capacity building in developing countries. According to Bollyky, this would include bringing international regulators to the United States, as well as sending FDA staff abroad, to facilitate the exchange of information and expertise. The report also calls on the US Government to work with Mexico, the host of the next meeting of the G20 nations, to add medical product safety to the G20 agenda. This will be an important and critical step to ensure that regulatory capacity building gets the buy-in and support from world governments, including the United States. As committee member Jim Riviere of North Carolina State University said, in order to have a “lasting and multiplier” effect on the safety of health products globally, we need to invest in capacity building and training for regulatory systems in all nations. This is one of the most important steps the FDA and others in the US Government can take to help ensure that new health products are safe and effective before they reach the people who need them most.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. As the international community marks World TB Day, GHTC members Aeras and the Global Alliance for TB Drug Development announced research projects for new tuberculosis (TB) prevention and treatment tools. National Institutes of Health (NIH) Director Francis Collins testified at a Congressional hearing on the agency’s budget. Collins emphasized NIH’s commitment to fund basic biomedical research as the agency’s highest priority. Rajiv Shah, head of the US Agency for International Development, was also on Capitol Hill this week to discuss the agency’s budget with members of Congress. "While foreign assistance represents less than one percent of our budget, we are committed to improving our efficiency and maximizing the value of every dollar," Shah said at the hearing. Alberto Gutierrez—director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health—writes about how the FDA is helping to improve access to TB diagnostic tools.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Rajiv Shah, administrator for the US Agency for International Development (USAID), has released his second annual letter, outlining major issues and initiatives that have shaped the agency since its inception 50 years ago. In the letter, Shah emphasizes the role of science, technology, and innovation in meeting USAID’s international health goals. The Drugs for Neglected Diseases initiative has received an award from the Wellcome Trust to develop a promising drug to treat Chagas disease being tested in adult patients in Bolivia. The National Institutes of Health and the pharmaceutical firm Eli Lilly and Company have announced that they will produce a publicly available resource to profile the effects of thousands of approved and investigational medicines. The resource aims to make drug development pipelines more productive and efficient. The winner of New York Times columnist Nicholas Kristof’s 2012 Win-a-Trip Contest names global health technologies as her passion.

Late last week, USAID Administrator Rajiv Shah released his second annual letter, outlining major issues and initiatives that have shaped the agency since its inception 50 years ago. Shah also charts a course forward for USAID, detailing areas that the agency should focus on in the coming years in order to make inroads in international development. One major area of focus is, of course, global health, and Shah rightly emphasizes the role of science, technology, and innovation in meeting USAID’s international health goals. The health component of the annual letter largely aligns with a recent effort at USAID to improve child survival. “[P]erhaps the most important choice is helping all children live to see their fifth birthday,” Shah writes, adding, “The good news is we have remarkably effective and cheap ways to help children survive.” Many of these methods—from insecticide-treated bednets to prevent malaria, antiretroviral drugs to prevent mother-to-child HIV transmission, and vaccines to prevent childhood killers like pneumonia and diarrhea—are available today because scientists and funders like the US Government made a commitment many years ago to develop new tools to fight these diseases. The new tools of yesterday have now become the standard tools to help children survive. Late last week, USAID Administrator Rajiv Shah released his second annual letter, which emphasizes science and innovation. Shah also highlighted how USAID continues to harness science and research to develop the next generation of new drugs, vaccines, and other technologies to save children’s lives. For instance, USAID’s Savings Lives at Birth initiative provides grants to foster innovative prevention and treatment options for pregnant women and newborns in rural, low-resource settings. USAID also supports research and development (R&D) for new health tools to benefit not just children, but a wide range of populations. “We’re also increasing our investments in core scientific research and technological innovation at USAID,” the letter reads. “Last year, our support of AIDS vaccine research led to the isolation of 17 novel antibodies that could each hold the key to ending the pandemic.” And just last month, the agency launched a new partnership with US colleges and universities to promote research for global development challenges, including health. It’s exciting to see that Shah continues, time and again, to recognize how science and innovation can overcome some of the world’s long-standing global health problems. We at the GHTC heard just two weeks ago at our annual Congressional briefing that health R&D produces real results for people at home and abroad. It’s heartening to have a leader at USAID who is so committed to the power of research, and who continues to provide such critical leadership.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kayla Laserson, director of the Centers for Disease Control and Prevention/Kenya Medical Research Institute Field Research Station in Kenya, writes about why US support for global health research is so critical. Investigators gave more detail about the positive results from the Partners PrEP Study at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle this week. The study found that antiretroviral treatment can prevent HIV transmission in couples where one partner is HIV-positive and the other is HIV-negative. Brazil’s National Health Surveillance Agency recently granted registration of a new child-friendly dosage of benznidazole, a treatment for Chagas disease. The dosage was developed through a partnership between the Pernambuco State Pharmaceutical Laboratory of Brazil and the Drugs for Neglected Diseases initiative. The University of Dundee has received funding from the Wellcome Trust and pharmaceutical company GlaxoSmithKline to research some of the world's neglected tropical diseases, including Chagas disease and African sleeping sickness.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The GHTC released its 2012 policy report at a Capitol Hill briefing this week. The report provides recommendations for policymakers so they can continue to save lives around the world by supporting research and development for new global health products. This is the third annual report released by the GHTC. The Infectious Disease Research Institute announced that the first clinical trial for a new vaccine for visceral leishmaniasis has begun in Washington State. The US Food and Drug Administration has approved the first-ever 4-in-1 flu vaccine. The Office of Science and Technology Policy has completed its review of final drafts of new federal scientific integrity policies. More than a dozen federal departments and agencies contributed to the process. Secretary of State Hillary Rodham Clinton testified in front of the Senate Appropriations Subcommittee on State and Foreign Operations on Tuesday. She discussed the Global Health Initiative and how it’s “consolidating programs, increasing partners' capacities, and shifting responsibilities to help target our resources where they are most needed and [have the] highest impact.”