By: Luciana Borio, M.D.
The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. To date, more than two thousand people in Guinea, Liberia, Nigeria and Sierra Leone have become infected, and more than twelve hundred have died. The stories of so many lives lost, and those of so many others fighting for their lives, are heartbreaking and tragic. We at the Food and Drug Administration are dedicated to helping end this outbreak as quickly as possible. And we are working hard to accelerate the development and production of treatments and vaccines to help prevent future outbreaks like this.
The primary approaches to contain the current outbreak remain standard public health measures. However, this outbreak presents complex challenges, in part because there are no FDA-approved treatments or vaccines for the Ebola virus. FDA has an important role during situations like this.
For example, we are working closely with U.S. government agencies that support medical product development – including the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the U.S. Department of Defense (DoD) – to speed the development and production of medical products that could help mitigate outbreaks like this. And we are working interactively with medical product sponsors to clarify regulatory and data requirements in order to move investigational products forward in development as quickly as possible. We also are in close contact with the World Health Organization and several of our international regulatory counterparts to exchange information about these investigational products for Ebola treatment, and to exchange information about how FDA works to facilitate development of and access to these products.
The experimental vaccines and treatments in development are in the earliest investigational stages and have not been fully tested for safety or efficacy. Only small amounts of some experimental products have been manufactured for testing, which means few courses, if any, are available for companies to make available for compassionate use in response to this outbreak. We are working closely with our U.S. government colleagues to have experimental treatments and vaccines available for clinical evaluation in the next few months. We are hopeful that, in the future, we will have medical products approved and manufactured for wide-scale use to address the Ebola outbreak. However, these products are not at that stage yet.
In the meantime, FDA is doing all we can to alleviate the situation. FDA has one of the world’s most flexible regulatory frameworks, which includes mechanisms to enable access to available investigational medical products when, based on certain criteria such as the balance between expected risk and benefit to the patient, it would be appropriate to use such products.
For example, under certain circumstances, clinicians may request the use of an Emergency Investigational New Drug (EIND) application under the FDA’s Expanded Access program to access investigational products outside of clinical trials for their patients. And under the FDA’s Emergency Use Authorization (EUA) authority, we can allow the use of an unapproved medical product – or an unapproved use of an approved medical product – for a larger population during emergencies, when there are no adequate, approved and available alternatives.
This month, we authorized the use of an Ebola diagnostic test, developed by DoD, under an EUA to detect the Ebola virus in DoD-designated laboratories. This test can help facilitate an effective response to the ongoing outbreak in West Africa by helping to rapidly identify patients infected with Ebola virus and facilitate appropriate containment measures and clinical care.
It is an unfortunate fact that, during outbreaks like this, fraudulent products that claim to prevent, treat or cure a disease rapidly appear on the market. FDA has learned of several fraudulent products that claim to prevent or treat this Ebola virus infection, including so-called natural remedies. Consumers who have seen these fraudulent products or false claims should report them to us. For our part, we will remain vigilant for fraudulent products and false product claims related to the Ebola virus, and will take enforcement actions as warranted to protect public health.
FDA stands ready to work with companies and healthcare providers to speed product development and to facilitate access to investigational products to treat patients when appropriate. We are fully committed to helping end this outbreak as quickly as possible and to sustaining our efforts to help prevent such outbreaks in the future.
Luciana Borio, M.D., is the Assistant Commissioner for Counterterrorism Policy and Acting Deputy Chief Scientist.