On November 10, 2014, FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0, an in vitro diagnostic device for the detection of Ebola viruses. This is the most recent in a series of measures taken by FDA in recent months to facilitate rapid access to drugs, biologics and medical devices with potential benefits in the prevention, diagnosis or treatment of infections with the Ebola virus.
Emergency Use Authorization
Pursuant to Section 564 of the Food Drug & Cosmetic Act (21 U.S. Code § 360bbb–3), The Secretary of the Department of Health and Human Services may declare a public health emergency or other circumstances justifying emergency use of an investigational drug, biological and medical device to prevent, diagnosis or treat the agent giving rise to the public health threat. The issuance of an emergency use authorization requires a determination that it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the disease or condition giving rise to the threat; that the known and potential benefits of the product outweigh the known and potential risks under the circumstances of the threat; and that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.
One such declaration has been made by the Secretary in the wake of the Ebola outbreak in West Africa – a declaration issued on August 5, 2014 that circumstances exist to support the authorization of emergency use of in vitro diagnostics for detection of Ebola virus. To date, FDA has authorized emergency use of six in vitro diagnostic devices pursuant to the declaration. Three of these products were developed by industry.
Expanded Access Programs
FDA also may authorize access for infected individuals to investigational products through its Expanded Access program authorities set forth at 21 CFR §312, Subpart I. Access may be obtained through a new Investigational Drug Application (IND) or through a protocol amendment to an existing IND. For example, FDA may approve an emergency Investigational New Drug (EIND) application submitted by a physician on an individual patient’s behalf when, in the physician’s opinion, the product is urgently needed to address a patient’s serious or life-threatening medical condition; there is no satisfactory alternative therapy available; and the patient is unable to obtain access to the product through existing clinical trials or expanded access protocols. Other available Expanded Access mechanisms include Single Patient (non-emergency) INDs, Intermediate Size Expanded Access INDs, and Treatment Use INDs for use of a product in populations that number in the hundreds or thousands. FDA has authorized the use of investigational drugs produced by Tekmira and ZMapp under these expanded access mechanisms.
Other FDA Actions to Facilitate Access to Products
In addition to relying on the existing regulatory pathways for Emergency Use and Expanded Access, FDA has engaged with domestic and international stakeholders, including regulatory authorities, non-government organizations and regulated industry, offering accelerated review of INDs and Investigational Device Exemptions (IDEs), collaborating on product development pathways and individual product protocols, and encouraging the use of Orphan Drug Designations to incentivize the development of promising therapies. With any luck, lessons learned from the close collaborations between FDA and relevant stakeholders, and the clinical trial designs under consideration to speed product development in the wake of the Ebola outbreak in West Africa will translate into models that can be used to enhance speed and efficiency of the drug and medical device development process in years to come.