Novel Coronavirus 2019-nCoV and FDA’s Emergency Use Authorization Authority

It is no secret why the novel coronavirus (“2019-nCoV”) outbreak in Wuhan City, Hubei Province, China quickly raised health concerns on an international scale. The coronavirus family contains member viruses with a similarly sinister and deadly past; viruses that seemingly appeared out of nowhere and rapidly spread. For example, two betacoronaviruses were the culprits behind the severe acute respiratory syndrome (“SARS”) and the Middle East respiratory syndrome (“MERS”) outbreaks that led to more than 10,000 confirmed cases of severe respiratory illness in humans.[i] Now, fears of an emerging global pandemic have understandably quickened as a result of mounting case infections, rising regional and global death tolls and limited knowledge as to this novel pathogen’s epidemiology and origin.[ii] In fact, the statistics paint a stark new reality as the virus has been observed in 32 countries/territories across five continents with over 80,000 confirmed cases as of this writing.[iii]

The Issue

As the world’s top researchers chase answers to aid in the diagnosis, treatment and prevention of 2019-nCoV in what has exploded into a veritable sprinter’s-paced marathon race, officials at the U.S. Food & Drug Administration (“FDA”) have also undertaken significant measures. On February 4, 2020, the Agency issued an Emergency Use Authorization (“EUA”) for a real-time, though unapproved, in vitro diagnostic panel developed by the Centers for Disease Control and Prevention (“CDC”) for the rapid,[iv] qualitative detection of the virus. Despite the significance of the action, CDC stated that about 200 test kits will be distributed to select domestic laboratories initially, and only so long as the government deems that circumstances justify the continued emergency use of the diagnostic under Section 564(b)(1) of the federal Food Drug and Cosmetic Act[v] (“FDCA”).

More recently, on February 7, 2020, the World Health Organization (“WHO”) issued a warning that pharmaceutical and medical devices supplied by China could be rendered in short supply if the 2019-nCoV epidemic continues in effect, unabated. FDA claimed that there were no present shortages linked to the outbreak, acknowledging the situation as “fluid.”[vi] Clearly, there is a real risk that if the outbreak is not promptly contained, critical export products, such as Chinese-manufactured bulk active pharmaceutical ingredients[vii] (used to produce certain FDA-approved finished dosage form drugs), may fall into shortage as manufacturers weigh whether to suspend operations or limit production. Shortages are not the only concern for FDA as they must also consider the impact that its recent personnel withdrawal from China could have on its ability to adequately monitor manufacturer compliance with good manufacturing practice regulations.

FDA’s Emergency Use Authorization Authority

Following the implementation of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013[viii] (“PAHPRA”), Congress amended Sections 564, 564A and 564B of the FDCA, creating specific authorities to address, among other things, management of emerging infectious diseases, clarifying how the Agency can support emergency preparedness and response to same using medical countermeasures (such as drugs, devices or biological products).[ix] Specifically, Section 564 of the FDCA permits FDA, after declaration of emergency by the Secretary of Health and Human Services, to authorize emergency use of either an unapproved medical product or an unapproved use of an otherwise approved product when there is “no adequate, approved, [or] available alternative.”[x] Relatedly, Section 564A provides that for already approved products, FDA can deploy enhanced medical countermeasures such as extending the expiration date of a drug that has been stockpiled for use in a qualifying emergency, waiving the applicable good manufacturing practice requirements (such as those related to storage and handling), authorizing emergency dispensing of a qualifying countermeasure without an individual prescription for same and also by permitting CDC to create emergency usage instructions concerning the FDA-approved conditions of use for qualifying products.[xi] Lastly, Section 564B permits government emergency response or public health agencies to stockpile or deploy medical countermeasures in anticipation of EUA issuance, investigational use authorization or FDA-approval for preparedness and rapid deployment purposes.[xii]

FDA Process for Issuing an EUA – Does Your Product Qualify?

Prior to issuing an EUA, the HHS Secretary must declare that circumstances exist justifying the authorization. The Secretary’s declaration (referred to as an “EUA declaration”), must be based on one of the following actions:

1. The Secretary of Homeland Security determines that there is either a domestic emergency or a significant potential for a domestic emergency that involves increased risk of attack with a chemical, biological, radiological and nuclear (“CBRN”) agent(s);
2. The Secretary of Defense determines that there is either a military emergency or a significant potential for a military emergency that involves an increased risk to the United States military forces of attack with a CBRN agent(s);
3. The Secretary of HHS determines that a CBRN agent or agents, or a disease or condition related to such agents, creates a public health emergency, exists or creates a significant potential for a public health emergency, that affects or is likely to affect, national security or the health and security of United States citizens living abroad; or
4. The Secretary of Homeland Security identifies a material threat, pursuant to section 319F-2 of the Public Health Service Act, that is sufficient to affect national security or the health and security of United States citizens living abroad.[xiii]

Following the Secretary of HHS’s issuance of an EUA declaration based on one of the four criteria above, the Secretary must consult with the Assistant Secretary for Preparedness and Response to the extent feasible and necessary given the circumstances, as well as with the Director of the National Institutes of Health (“NIH”) and the Director of CDC. Provided that all required statutory criteria are met, the Commissioner of FDA may then authorize the emergency use of an unapproved product or an unapproved use of an approved product. Additionally, when circumstances require, an HHS EUA declaration may support issuance of more than one EUA, such as a situation where the FDA authorizes emergency use for multiple diagnostic tests in response to an EUA for emergency use of diagnostics for a specified biological agent.

Criteria for Issuance of an EUA

While an EUA declaration is in effect, FDA may authorize the introduction of a medical product into interstate commerce as long as the product is intended for use during an actual or potential emergency. Following issuance of an EUA declaration, FDA may issue an EUA only if it concludes that the four statutory criteria for issuance have been met. However, if the product does not meet the statutory criteria or FDA determines that the product is not otherwise appropriate for an EUA, alternative regulatory mechanisms, such as Investigational New Drug applications, which may allow for expanded access, could be an effective way to provide access to unapproved uses of a product in emergency situations.

The four statutory criteria for issuance of an EUA include the following:

1. Serious or Life-Threatening Disease or Condition: The CBRN agent(s) referenced in HHS Secretary’s EUA declaration must be capable of causing a serious or life-threatening disease or condition.
2. Evidence of Effectiveness: EUAs are provided only for medical products that “may be effective” to prevent, diagnose or treat serious or life-threatening diseases or conditions caused by a CBRN agent(s) identified in the HHS Secretary’s declaration of emergency or threat of emergency under section 564(b). EUA products may also include products aimed at mitigating a disease or condition caused by an FDA-regulated product that is used to diagnose, treat or prevent a disease or condition caused by a CBRN agent.
3. Risk-Benefit Analysis: The FDA Commissioner must determine that the known and potential benefits of a product, as used in the diagnosis, prevention or treatment of the identified disease or condition, outweigh the known and potential risks of the product before granting an EUA. This requires the Agency to thoroughly assess the threat posed by the CBRN agent(s) and to evaluate all available scientific evidence to make a complete risk-benefit determination.
4. No Alternatives for FDA: The FDA must determine that there is no adequate, approved and available alternative to the potential EUA product for diagnosing, preventing or treating the disease or condition. If there are insufficient supplies to adequately meet the emergency need, the FDA may determine that an otherwise viable alternative is “unavailable.” Alternatively, a potential alternative may be deemed “inadequate” for reasons of contraindications or dosage forms in specific populations, such as the elderly.[xiv]

How can an EUA facilitate efforts to combat global threats such as coronavirus?

As world health experts attempt to stem the rapidly increasing spread of the coronavirus, companies with existing FDA-approved or cleared products for other indications should consider the fact that EUAs can quickly and drastically reduce cycle time. However, product readiness, accuracy and scalability are equally important considerations. Take for example, the recent laboratory reports of inconclusive results associated with use of the CDC’s test kits as reported here. Clearly, there are a number of important variables that must be carefully weighed when developing therapies to counter emerging and imminent threats.

In summary, there may be other products for which companies could seek an EUA to aid in combating this growing public health crisis, and organizations with currently approved or cleared products, as well as those with other promising detection or treatment solutions, should be thinking dynamically about how to deploy the resources at their disposal. Hall Render attorneys are actively monitoring the novel coronavirus outbreak and related activities undertaken by the FDA, CDC and WHO. If you have any questions or would like additional information about this topic, please contact:

• Andrew Harrison at (414) 721-0467 or aharrison@wp.hallrender.com;
• Amy Poe at (919) 228-2404 or apoe@wp.hallrender.com; or
• Your regular Hall Render attorney.

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