In response to the Ebola outbreak in the Democratic Republic of Congo (DRC), the Food and Drug Administration has announced steps the agency is taking to make diagnostic and medical products available as part of critical response efforts.
In addition to providing scientific and regulatory advice to medical product developers, the FDA is using its authorities to ensure Merck’s investigational Ebola Zaire vaccine is made available appropriately to vaccinate high-risk populations in the DRC. Additionally, the FDA also is committed to facilitating the development of investigational drugs for the treatment of Ebola virus and supporting access to these products under appropriate regulatory pathways, FDA Commissioner Scott Gottlieb, MD, said in a.
Clinical trials that are adaptive to the circumstances of an outbreak are essential, he added. “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.”
Further, as there are no approved treatments or vaccines for Ebola, the agency will be monitoring for false product claims to protect consumers from fraudulent products claiming to prevent, treat, or cure the disease.
“The FDA knows that it takes a sustained, robust, and globally coordinated effort to best protect our nation from various infectious disease threats,” Dr. Gottlieb wrote. “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.”