FDA, International Regulators Banding Together to Fight Ebola
Global regulators are banding together in the hopes of accelerating new therapies to treat a large and growing outbreak of the Ebola virus, a type of highly fatal hemorrhagic fever.
In a 4 September 2014 statement, a broad coalition of regulatory agencies under the umbrella of the World Health Organization's (WHO) International Coalition of Medicines Regulatory Authorities (ICMRA) said they would be working together "to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks."
The Ebola outbreak is already by far the "most severe and most complex" outbreak of the disease in history, regulators noted. The virus currently lacks any approved treatments, which has put pressure on regulators and companies to grant emergency use access to the small handful of drugs which have shown promise at treating Ebola in animal studies. Companies developing Ebola treatments include Mapp Biopharmaceutical, Tekmira Pharmaceutical, Fujifilm, Newlink Genetics, Biocryst Pharmaceuticals, and others.
In its statement, ICMRA said that its member regulators "have committed to enhanced cooperation with the WHO and between regulatory agencies to encourage submission of regulatory dossiers and evaluation of the submitted information on potential new medicines."
"The aim is to accelerate access to investigational treatments for patients most in need during the current outbreak," it continued. "The enhanced cooperation also aims to ensure that in the future, public health authorities in countries affected by Ebola have safe and efficacious medicines at their disposal, and so strengthen their ability to respond effectively to outbreaks and to save lives."
But what regulators will be able to do may be limited. As explained last month by Regulatory Focus, treatments for the Ebola virus face many challenges to obtaining regulatory approval. Notably, the disease is so deadly (and typically rare) that it is difficult to study in humans. In addition, many of the drugs, even if found to successfully treat or cure the disease, are in such early stages of development that companies may not be able to manufacture sufficient quantities of the drug in time to help stem the outbreak.
The main option left to regulators will likely be granting access to investigational therapies when and where it is feasible to do so. In addition, regulators might allow companies greater leeway to manufacture Ebola drugs, bypassing the usually rigorous regulatory requirements needed to establish and validate a new manufacturing process.
ICMRA regulators said they would make decisions using a "greater degree of scientific uncertainty" than under normal circumstances.
Members of ICMRA include:
- Food and Drug Administration (FDA), United States.
- Therapeutic Goods Administration (TGA), Australia
- National Health Surveillance (ANVISA), Brazil
- Health Products and Food Branch, Health Canada (HPFB-HC), Canada
- China Food and Drug Administration (CFDA), China
- European Medicines Agency (EMA)
- Health Product Regulatory Authority (HPRA), Ireland
- Italian Medicines Agency (AIFA), Italy
- Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Medicines Evaluation Board (MEB), Netherlands
- Health Sciences Authority (HSA), Singapore
- Medicines Control Council (MCC), South Africa
- Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom