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Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Time and time again, we’re reminded that disease knows no borders. While our globalized world and modern transportation helps promote economic prosperity, these features also provide an easier platform for the spread of emerging infectious diseases. In the past 15 years alone, we’ve faced nearly 10 serious outbreaks of deadly pathogens. But perhaps none of these outbreaks was as ominous and deadly as the 2014–2015 Ebola outbreak in West Africa that claimed the lives of more than 11,300 people.

The U.S. Food and Drug Administration has long played a critical role in protecting the public from these emerging threats. In recent years, Congress has entrusted the agency with new authorities and resources to advance the development of countermeasures to address emerging threats. To pursue these mandates, the agency has built a strong team of scientists, researchers and policy experts that are dedicated to preparing our nation to rapidly respond to emerging infectious diseases as well as chemical, biological, radiological and nuclear threats, whether these events are naturally-occurring or man-made.

During the 2014-2015 Ebola outbreak, the FDA took new steps to advance the availability of investigational medical countermeasures, including drugs, vaccines and diagnostic tests. As we closely monitor the current Ebola outbreak in the Democratic Republic of Congo (DRC), our team is employing our experiences, resources and knowledge from the 2014-2015 incidents. We’re committed to helping the people of the DRC effectively confront and end the current outbreak. The FDA is building on the lessons we learned from that 2014-2015 Ebola epidemic to assist in the global response to this current outbreak and help mitigate the threat by making medical products available as part of critical response efforts.

Global health authorities are taking concerted steps to contain the outbreak announced on May 8 by the DRC’s Ministry of Health. However, its appearance in a large urban center located on the Congo River has increased the risk of further spread both within the DRC and to neighboring countries. At the FDA, we’re leveraging our robust global networks and working with federal colleagues, the medical and scientific communities, industry and international regulatory counterparts and organizations—including the World Health Organization (WHO)—to support these international response efforts.

These efforts include continuing to provide scientific and regulatory advice to medical product developers and U.S. government agencies that support medical product development, including the National Institutes of Health, the Biomedical Advanced Research and Development Authority, the U.S. Centers for Disease Control and Prevention and the U.S. Department of Defense. One aim is to help accelerate Ebola virus product development programs. Prevention is one of the most effective ways to curb the spread of emerging infectious diseases. The FDA is focused on advancing the availability of an Ebola vaccine to help address the ongoing public health response. In 2016, Merck announced that the FDA granted breakthrough designation to the company’s investigational Ebola Zaire vaccine. That vaccine is currently being used to vaccinate high-risk populations in the DRC. This is one measure of how the scientific work set in motion during the 2014-2015 epidemic has changed the contours of how we grapple with the current outbreak. To advance these opportunities, the FDA is using our authorities to ensure that this investigational vaccine is being appropriately made available in the DRC to help control the outbreak.

While prevention is an important facet to the FDA’s outbreak response efforts, we also know that the availability of safe and effective medical products for the treatment of Ebola is imperative to support individuals who may already be affected directly by this life-threating pathogen. That’s why the FDA is also committed to facilitating the development of investigational drugs for the treatment of Ebola virus and supporting access to these products under appropriate regulatory pathways.

Specifically, the FDA’s experts are supporting the WHO’s efforts to assess currently available data on investigational drugs for Ebola as well as possible mechanisms to enable appropriate access outside of a clinical trial setting until scientifically sound clinical trials can be established. We’re also helping assist sponsors to make sure an adequate supply of these treatments is available. In addition, we’re continuing to work closely with diagnostic developers and researchers to support Ebola test development and availability. There are 10 Ebola diagnostic tests available for emergency use under the FDA’s Emergency Use Authorization authority. The FDA has also cleared one test for the detection of Ebola that can be used in designated laboratories. The FDA remains closely engaged with diagnostic manufacturers to assess current inventories of these tests as well as manufacturing capacity in support of response efforts.

One of the ways that the FDA has strengthened our suite of products aimed at outbreak preparedness and our response tools is by continuing to highlight the importance of generating sound, scientific data using appropriately designed clinical trials to show whether investigational products can provide benefits to patients. During the 2014-2015 Ebola outbreak, the FDA recognized that some of the medical products that initially appeared to show great promise sometimes, when subjected to objective testing, were not effective or may have done more harm than good. That’s why, as the FDA continues to encourage medical product development, we also strongly advocate for the establishment of appropriately designed clinical trials as the most reliable means to show whether investigational products are both safe and effective. We recognize that these trials need to be adaptive to the circumstances in which the trials are being conducted, and to the products that are being offered. The goal is to collect the best information possible.

We’ve also learned from experience responding to previous outbreaks that efforts must include protecting unsuspecting consumers from fraudulent products claiming to prevent, treat or cure a disease. Unfortunately, this kind of fraudulent activity frequently occurs during outbreak situations. As part of the response to the current Ebola outbreak in the DRC, we’re taking action to protect consumers from sham products by monitoring for false product claims. It’s important for consumers to remember that there are no approved treatments or vaccines for Ebola available for purchase on the Internet. Consumers who’ve seen fraudulent products being marketed or false claims are encouraged to report them to the FDA.

The FDA knows that it takes a sustained, robust and globally coordinated effort to best protect our nation from various infectious disease threats. Our experts work year-round ensuring our preparedness for potential outbreak situations. We’re committed to supporting the people of the DRC, and preventing a worsening circumstance during the current outbreak. And we remain highly engaged in the international response efforts. Our teams are committed to using our authorities to their fullest extent to help end this outbreak as quickly as possible and to sustaining our efforts to help prevent future outbreaks.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.