Source: https://www.medical.saint-gobain.com/blog/background-and-highlights-us-fda-emergency-use-authorization
Timestamp: 2020-06-02 13:11:09
Document Index: 584464990

Matched Legal Cases: ['§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564', '§ 564']

Background and Highlights on the US FDA Emergency Use Authorization | Medical
Background and Highlights on the US FDA Emergency Use Authorization
Charles Golub (Market Development Manager – Saint-Gobain Life Sciences, Medical Components)
Dorothy Wilkerson (Global Regulatory Affairs – Saint-Gobain Life Sciences, Medical Components)
Lina Nguyen (Global Marketing Director – Saint-Gobain Life Sciences, Medical Components)
Emergency Use Authorizations (EUA’s) are being used for everything from ventilators coming to market to diagnostics tests. But where did this part of law come from and for how long will the authorizations last? It turns out most of the section of the FDA that first enabled the EUA was done so through an act called “Project BioShield” which was enacted in 2004. It was written to protect the US from anthrax attacks such as those that were taking place in 2001 through the mail. At the time it was enacted, the only way to get unapproved products into the market in the event of an emergency was through an Investigational Device Exemption, which allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data. So legislation that is less than 20 years old is the only thing enabling drugs, new test methods, and devices to be used to battle this pandemic right now. EUA has been enacted only a handful times since it was established, notably the aforementioned anthrax (2004), H1N1 (2009), Ebola (2014), and Zika (2016).
When reading about these authorizations, it’s important to note that they are temporary and once the public health crisis ends, so do their authorizations. This means the products and services will no longer be approved for use, but that doesn’t necessarily mean they won’t still be in operation. Some of these may have some staying power, and manufacturers may have easier roads to obtaining proper approvals. Other manufactures will probably never be heard from again (will GM make masks long term?). So let’s take a closer look at how these EUA’s are achieved and how long they will last.
In general, in order to achieve an EUA you must present the following information to the FDA to show that the product is both safe and effective (see Appendix A for Required vs Discretionary Conditions):
A description of the intended use of the product
A description of the approval status, both FDA and in any other region of the world
The need for the product
Information on the chemistry of the product and the manufacturing controls in place
Labeling of the device
The FDA then reviews this information, gives a notice of authorization, asks for clarification or more information, or denies the request.
What is the length of time these devices, test methods, and drugs will be allowed and how does it end?
From the FDA’s website: “When an EUA declaration is terminated, then any EUA(s) issued based on that declaration will no longer remain in effect. The HHS Secretary’s EUA declaration will terminate on the earlier of: (1) a determination by the HHS Secretary that the circumstances that precipitated the declaration have ceased …, or (2) a change in the approval status of the product such that the authorized use(s) of the product are no longer unapproved.
Before an EUA declaration terminates, the Secretary of HHS must provide advance notice that is sufficient to allow for the disposition of an unapproved product, and of any labeling or other information provided related to an unapproved use of an approved product.”
From each phase of your product development, our expertise can help to guide you through any hurdles you may encounter. Through partnering with Saint-Gobain, the process of bringing your device to market can go smoother, and help to ensure your product has more staying power after the crisis has ended.
Appendix A. EUA Conditions of Authorization: Required vs. Discretionary
Unapproved Product
Unapproved Use of an Approved Product
FD&C Act Section
Information (“fact sheets”) for healthcare providers administering the product
(significant known/potential benefits/risks of product and extent to which benefits/ risks are unknown; FDA has authorized emergency use Required Required § 564(e)(1)(A)(i)
§ 564(e)(2)(A)
Information (“fact sheets”) for product recipients
(significant known/potential benefits/risks of product and extent to which benefits/ risks are unknown, option to accept or refuse product, consequences of refusing, available alternatives, FDA has authorized emergency use) Required Required § 564(e)(1)(A)(ii)
Adverse event monitoring and reporting Required Discretionary § 564(e)(1)(A)(iv)
(by product manufacturers) Required Discretionary § 564(e)(1)(A)(iv)
(by persons other than product manufacturers) Discretionary Discretionary § 564(e)(1)(B)(iv)
(which entities may distribute product and how to perform distribution) Discretionary Discretionary § 564(e)(1)(B)(i)
(who may administer product and categories of individuals to whom, and circumstances under which, product may be administered ) Discretionary Discretionary § 564(e)(1)(B)(ii)
(concerning product safety/effectiveness) Discretionary Discretionary § 564(e)(1)(B)(iii)
CGMP and prescription waiver or limit Discretionary Discretionary § 564(e)(3)
Advertising/other promotional material Discretionary Discretionary § 564(e)(4)
(any other condition FDA finds necessary or appropriate to protect the public health) Discretionary Discretionary § 564(e)(1)(B)