Recently, the Secretary of the Department of Health and Human Services (HHS) determined, according to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a public health emergency, which has a serious potential to influence the health as well as the national security of citizens of the U.S. staying in other countries. This emergency involves the novel coronavirus first diagnosed in China in 2019. The novel coronavirus has given the name severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19.
Based on the findings, HHS’ secretary has afterward announced that circumstances occur explaining the authorization of emergency utilization of in vitro diagnostics for the diagnosis and detection of COVID-19, personal respiratory protective devices, and other medical devices, such as different products utilized as medical devices in the COVID-19 emergency according to section 564 of the Act.
Some of the key points regarding emergency use authorization of medical products are as follows:
Eligibility for an emergency use authorization (EUA)
Section 564 allows the FDA commissioner to approve the introduction into interstate commerce of a device, biological product, and drug planned for utilization in potential or an actual emergency in the effective period of a declaration. EUA candidates contain uses and products, which are not licensed, announced, and approved under sections 505, 510(k), and 515 of the FD&C Act or section 351 of the PHS Act. Moreover, the commissioner can issue EUA only if, after communicating with the Director of CDC and Director of NIH.
Categories of Products
The array of potential EUA products contains devices, drugs, and biological products. Candidate products include those products, which have not been announced or cleared under the FD&C Act or the PHS Act, these products are termed as “unapproved products”. Additionally, it also includes unapproved utilization of approved drugs and cleared or approved devices. Section 564 does not need an investigational device exemption (IDE) or investigational new drug application (IND) to be charged for EUA candidate products, though FDA expects that number of the unapproved products already will have been under assessment via such mechanisms.
Uses and products, which are eligible for authorization are those which “may be effective” in order to treat, diagnose, and prevent life-threatening or serious diseases or conditions, which can be induced by the particular chemical, nuclear, or biological agents that result in the declared emergency. Moreover, these eligible products could also contain those products, which could be efficient to decrease condition or disease induced by the FDA-regulated product utilized to prevent, treat, or diagnose disease or condition induced by such agents. The “may be effective” standard for EUAs offers for a lower level of evidence than the “effectiveness” standard that the FDA utilizes for product authorizations.
Products are eligible for emergency use authorization if FDA finds out that the potential and known advantages of the product when utilized to treat, diagnose, and prevent the identified condition or disease, outweigh the potential and common products’ risks. In finding whether the potential and known advantages of the products overshadow the potential and known risks, FDA expects to examine the quantity and quality of the evidence, given the present state of scientific knowledge, of risks and benefits. Furthermore, the FDA intends to utilize this information in order to make an overall risk-benefit conclusion. In order to complete this task, the FDA thinks to see the total scientific evidence that could arise from different sources.
Substitutes to products
The FDA commissioner could circulate a EUA if he finds out that there is insufficient, available, and approved alternative to the candidate product. If there are inadequate supplies in order to fulfill the emergency requirements, a potential alternative product could be considered “unavailable”. In addition to this, it may be termed “inadequate” if there are mismatching data for particular conditions or populations.
Request for consideration for EUA
In order to assess a request for consideration for EUA, the FDA suggests that the information to be submitted, which is mentioned below:
- Product description and expected usage
- Explanation and identification of what unfulfilled requirements would be addressed by the issuance of the EUA
- Product’s approval description as well as clearance status
- List of every place where the product is manufactured if it is authorized, and manufacturer’s Good Manufacturing Practices (GMP) status
- Identification of approved alternative products
- Proposed labeling (if applicable).
- Available effectiveness and safety information for the product
- Discussion of advantages as well as risks
- Right of reference (if applicable).
- Information on manufacturing, controls, and chemistry
- Guideline for utilization of the EUA product
Conditions of authorization
Under section 564, the FDA Commissioner can authorize conditions on a EUA. Section 564(e) needs the FDA Commissioner to authorize particular conditions on EUA authorization, which the Commissioner determines correct or require to protect the public health, and allows the Commissioner to authorize other conditions that he determines essential and correct to shield the public health. Section 564(e) authorized conditions could contain, for instance, essentials for distribution of information to providers authorized product recipient and dispensers, data collection and analysis, restrictions on product advertising, limitations on GMP requirements, adverse event monitoring and reporting, recordkeeping and records access, and administration.
Some statute specifies conditions are compulsory to the intensity practicable for authorizations of unapproved products and discretionary for authorizations of unapproved uses of approved products. Additionally, some of these conditions could be applicable to EUA product manufacturers; on the other hand, other conditions could be applicable to any person who executes any activity for which the authorization is issued. Apart from this, other authorities have been given to the commissioner for public health protection.
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