Posted 23 April 2015
By Alexander Gaffney, RAC
The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies.
Under emergency scenarios—the outbreak of a new disease or a disaster—federal legislation permits the US Food and Drug Administration (FDA) to authorize the use of new medications and medical products intended to meet an otherwise unmet need.
Specifically, the Public Readiness and Emergency Preparedness Act (PREP Act) of 2005, as modified by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, permits HHS to declare a "public health emergency" or identify a threat as posing a imminent and "credible risk" to public health.
If such a declaration is made, FDA is then permitted to use this emergency authority to grant Emergency Use Authorization (EUAs) to medical products and countermeasures intended to prevent, treat, diagnose or cure the identified threat.
By their very nature, products granted EUA status are not known to be safe and effective. If they were, they would either already be approved or be given a traditional approval decision by FDA (and likely be stockpiled in advance in the Strategic National Stockpile).
Instead, nearly all EUAs are unapproved products whose use is temporarily authorized based on scientific evidence that they could be used to diagnose, treat or prevent a serious or life-threatening disease or condition. "When scientific evidence is available to support such a use in an emergency, issuing an EUA enables response stakeholders to use, or prepare to use, an MCM without violating the Federal Food, Drug and Cosmetic Act," FDA explains on its website.
Read more about FDA's Emergency Use Authorization (EUA) process here.
But authorization to bring a product to market is only the first half of the battle to ensure products are available to consumers.
The other half is a legal matter. Federal law permits HHS to shield medical products manufacturers from legal liability for products properly marketed under an EUA. The hope is that manufacturers will not be shy about bringing forth new products to try to treat a potential emergency.
Without that legal liability protection, companies might be liable for legal damages for the side effects caused by their drugs, vaccines and diagnostic products, which are typically not nearly as well understood as fully approved products.
For its part, the US government is both willing and able to grant companies legal protections.
In December 2014, HHS declared that it would "provide liability protection for activities related to Ebola virus disease vaccines" so long as those vaccines (of which there are three) complied with federal rules and regulations under PAHPRA and the PREP Act.
Now HHS has extended those protections to a manufacturer of a biopharmaceutical product used in the fight against Ebola: Mapp Biopharmaceutical's ZMapp, a monoclonal antibody therapeutic product.
In a little-noticed Federal Register notice published by HHS on 22 April 2015, HHS said the manufacturer would be exempted from legal liability so long as it is making a "covered countermeasure"—ZMapp—identified by the government.
Workers, distributors and government planners using ZMapp are similarly protected from legal liability under HHS's announcement.