As the COVID-19 pandemic continues to rapidly unfold, medical professionals, infected patients, and the general public are in dire need of new equipment, treatments, and medical devices – and fast.
There are many products in development or already available that could offer much needed assistance to hospitals and the general population, but many of these products are either not approved for use by the Food and Drug Administration (FDA), or are approved for a different use. Typically, it would take months or years for the FDA to approve a new product or approve a new indication for an existing product. But considering the immediate need for these products, this timeframe is not acceptable.
Thankfully, the FDA can quickly accelerate the ability of new products to get to patients under an Emergency Use Authorization (EUA). Under an EUA, the FDA has the authority to temporarily allow use of unapproved medical products and unapproved uses of approved medical products during an emergency involving chemical, biological, radiological, and nuclear (CBRN) agents. These products can be used to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. This authority is given to the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA) and is applicable to drugs, biologics and medical devices.
The FDA is already putting the EUA to good use in response to the COVID-19 outbreak. Whether it be ventilators, new drugs, facemasks or other personal protective equipment, the FDA has been expediting the authorization of new products over the last few months as needed.
Many life sciences companies have products that can help mitigate this pandemic and save lives as well, and on May 5, Buchanan Ingersoll & Rooney life sciences attorneys, in partnership with Biocom, held a webinar attended by many of the industry’s brightest minds to discuss how companies can receive this emergency use authorization. Below are a few considerations discussed during the webinar that all life sciences companies must keep in mind when navigating the EUA process:
1. Understand the criteria for EUA authorization
For the FDA to begin issuing EUAs, the Secretary of the Department of Health and Human Services (HHS) must first issue a “EUA Declaration” justifying authorization of emergency use. On Feb. 4, HHS Secretary Alex Azar issued an EUA Declaration for the current pandemic on grounds that the COVID-19 outbreak presents a public health emergency that is affecting our nation’s public health. The grounds for this declaration provide the basis for FDA’s issuance of EUAs during the COVID-19 pandemic.
When reviewing company submissions under the current EUA Declaration, the FDA looks at specific criteria. In order to receive an authorization, a product must meet all four of the below criteria:
- It can help mitigate a serious or life-threatening disease or condition
- There is evidence the product may be effective
- The benefits outweigh risks (known and potential)
- There is no adequate, approved, and available alternative product
Before submitting a product for EUA review, it is important that decision makers at life sciences companies be able to make the argument that their product meets the above characteristics.
2. Know what info is needed for the submission
Given the speed at which the FDA moves to issue EUAs, it is critical that life sciences companies submit thorough and complete applications. These applications often must go into detail about the product’s effectiveness, history of production and use, clinical trial data, and more. Companies must also make a strong case for why the product is needed right now in light of, and how it could positively impact, the COVID-19 pandemic. Safety information is crucial to the review process, as well as information about the chemistry, manufacturing, and controls (CMC) for the product. Submissions must also include where the product is manufactured and the current good manufacturing practice (cGMP) status of the site.
In some situations FDA has issued a general EUA to cover a category of conforming products, such as face masks. In those case, there may be less information to submit—even though the company will be required to comply with the conditions of authorized use in the general EUA. Accordingly, marketing your product under an EUA may be more or less burdensome depending on what type of product it is and whether or not a general EUA already exists that could cover your product.
3. Considering existing EUAs
The FDA has already issued numerous EUAs during the COVID-19 pandemic and these previous EUAs may be useful to life sciences companies pursuing an EUA for a similar product. The FDA has authorized various EUAs for in vitro diagnostic products (IVDs), SARS-CoV-2 antibody tests, high-complexity molecular-based laboratory developed tests (LDTs), personal protective equipment (PPE) and decontamination systems, ventilators and other medical devices, and COVID-19 therapeutics. Before submitting their own application, companies should consider what information from existing EUAs they can leverage to their advantage and whether there is an existing general EUA that could cover their product. Reviewing these existing EUAs will provide life sciences companies with valuable insights that can help them receive their own authorizations.
4. Keep an open dialogue with the FDA
Having an early, open, and ongoing dialogue with the FDA will considerably help a life sciences company’s chances of being issued an EUA. These discussions would often cover such issues as a product’s suitability for an EUA, potential uses, user safety concerns and the product’s potential efficacy. You should also discuss any previous or ongoing clinical trials that may have been conducted with your product and the resulting data. Companies can address any data shortfalls or missing pieces of information to alleviate any concern from the FDA. These conversations will help the FDA quickly and effectively evaluate a company’s submission and can speed the authorization process.
Maintaining an ongoing dialogue will also help life sciences companies stay on top of the rapidly evolving pandemic. The FDA is updating its policies and response to the situation on a near daily basis, including issuing new EUAs and amending existing ones. Life science companies are wise to continually stay abreast of any new developments that can help their own chances of receiving an emergency use authorization.
Lending a hand during times of need
The FDA’s EUA is an effective tool for quickly bringing much needed products to market that can alleviate the COVID-19 outbreak’s negative impact on public health and society at large. Any life sciences company that has a product they believe can offer assistance should consider seeking an EUA. But before starting the process, they must keep in mind the above considerations, which can make or break the success of their efforts.
To watch the webinar recording, click here.
For more cutting-edge perspectives on legal and business implications of COVID-19, visit our COVID-19 resource center.