Emergency Use Authorization for medical devices and drugs to fight against COVID-19 in the United States
The COVID-19 pandemic has made adjustments to many areas of society, including the regulatory sector for drugs and medical devices (MD). In this regard, in many countries, legislation regarding the introduction of drugs and MD to the market has been adapted to the emergency situation. For example, in Russia, Government Resolution No. 430 was adopted for MD, allowing to approve a series (batch) of MD within 5 working days in the absence of a request. Is there a similar procedure in other countries? This article will consider the regulatory practice of the United States.
In the United States, there is an established procedure for the Emergency Use Authorization for medicinal products, which is described in the Federal Food, Drug, and Cosmetic Act, Section 564. Under this Act, when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.
In the case of COVID-19, a declaration was issued on February 4, 2020, according to which drugs for the treatment of coronavirus infection were subject to Emergency Use Registration. On February 7, 2020, a similar declaration was issued for MD designed to detect and diagnose 2019-nCoV.
Currently, the accelerated registration procedure is also approved for the following MD: Hemodialysis MD, infusion pumps, personal protective equipment, ventilators, wearable patient monitoring devices.
In order to initiate an Emergency Use Authorization (EUA) after the issuance of the above declarations, the applicant submits a request to the FDA containing the following information:
- A description of the product and its intended use;
- A description of the product’s FDA approval status (e.g., whether the product is unapproved or whether it is approved but the EUA is for an unapproved use);
- The need for the product, including identification of any approved alternative product(s) and their availability and adequacy for the proposed use, and the unmet need(s) the EUA would address;
- Available safety and effectiveness information for the product;
- A discussion of risks and benefits;
- Information on chemistry (as applicable), manufacturing, and controls; a list of each site where the product, if authorized, is or would be manufactured, and the current CGMP status of the manufacturing site(s);
- Information about the quantity of finished product on hand and the surge capabilities of the manufacturing site(s);
- Information comparable to an FDA-approved package insert or instructions for use;
- Any right of reference, as applicable.
After dossier submission, the FDA prioritizes requests based on many criteria, including severity of the disease/condition and incidence, urgency of treatment required, availability and adequacy information on how effective and safe the product is, etc., and then reviews the request and dossier.
The exact terms for reviewing the dossier are not specified in the regulatory legal acts, as they are limited by such factors as the workload of the staff, the specifics and quality of the request submitted and the product dossier, nature and seriousness of the declared state of emergency, but should be limited to a few hours or days.
As a result of the review, an emergency use authorization for the product is issued, which is valid as long as the declaration issued by the Minister of Health and Human Services is valid.