Does Your Unapproved Device, Drug or Biologic Qualify for an Emergency Use Authorization (EUA)?

The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV).  Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat.

In late January, FDA announced its strategy to advance development of medical countermeasures to prepare for the coronavirus threat.  FDA made clear in its January strategy statement that private industry has a role:

As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.  (Italics added.)

As a first step, on February 4, the Secretary of Health and Human Services (HHS) issued a public health emergency determination for the coronavirus.  This determination effectively authorizes FDA to issue emergency use authorizations (EUAs) for unapproved devices, drugs, and biologics (or unapproved uses of otherwise approved products) that may be effective medical countermeasures to combat a pandemic.  FDA also has additional authorities, e.g., to waive expiration dating and Good Manufacturing Practice (GMP) requirements.

On the same date as the determination, FDA issued its first EUA, authorizing use emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel.  Prior to the EUA, this test was limited to use at CDC laboratories; FDA’s authorization allows the use of the test at any CDC-qualified lab across the country.

Products made by private industry are also eligible for EUAs.  FDA has issued a detailed guidance on how to work with the agency to obtain one.  In a nutshell, to issue an EUA, FDA must find:

• The threat (e.g., coronavirus) is capable of causing a serious or life-threatening disease or condition. (That requirement is clearly met.)
• The potential product is intended to to diagnose, treat, or prevent the coronavirus. It must be shown that it “may be effective” in achieving this intended use.
• The known and potential benefits of the product outweigh the known and potential risks, looking at the totality of the scientific evidence. Such evidence may include (but is not limited to): results of domestic and foreign clinical trials, in vivo efficacy data from animal models, and in vitro data.
• There must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the coronavirus. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need. A potential alternative product may be considered “inadequate” if, for example, there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the coronavirus is or may be resistant to approved and available alternative products.

The bottom line – if a firm has a device, drug or biologic not yet FDA‑cleared or approved, but that could help fight the corona virus ‑ now is the time to look at FDA’s guidance and see whether an EUA might be appropriate.