April 15th, 2020
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):
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.
| Condition | 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) § 564(e)(2)(A) |
| Adverse event monitoring and reporting | Required | Discretionary | § 564(e)(1)(A)(iv) § 564(e)(2)(A) |
| Recordkeeping and reporting (by product manufacturers) |
Required | Discretionary | § 564(e)(1)(A)(iv) § 564(e)(2)(A) |
| Recordkeeping and reporting (by persons other than product manufacturers) |
Discretionary | Discretionary | § 564(e)(1)(B)(iv) § 564(e)(2)(A) |
| Product distribution (which entities may distribute product and how to perform distribution) |
Discretionary | Discretionary | § 564(e)(1)(B)(i) § 564(e)(2)(A) |
| Product administration (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) § 564(e)(2)(A) |
| Data collection and analysis (concerning product safety/effectiveness) |
Discretionary | Discretionary | § 564(e)(1)(B)(iii) § 564(e)(2)(A) |
| CGMP and prescription waiver or limit | Discretionary | Discretionary | § 564(e)(3) |
| Advertising/other promotional material | Discretionary | Discretionary | § 564(e)(4) |
| Other (any other condition FDA finds necessary or appropriate to protect the public health) |
Discretionary | Discretionary | § 564(e)(1)(B) § 564(e)(2)(A) |
Charles Golub is the Market Development Manager for Saint-Gobain Medical Components focusing on finding the unmet needs of future customers and providing then with Saint-Gobain’s creative solutions. Prior to joining the medical marketing team, he spent 12 years in Research and Development and has an expertise in bringing innovative solutions to market. He has technical expertise in polymer materials and blends as well as analytical methods of analyzing them and he holds over a dozen patents.
Dorothy Wilkerson obtained her Bachelor’s and Master’s degrees both in Biomedical Engineering. Dorothy has over 15 years of experience at several medical device companies in engineering, quality, and regulatory-related roles. Dorothy works closely with the Saint-Gobain Life Sciences Medical Components commercial team in the business development initiatives, business reviews, and continued execution of Saint-Gobain’s medical strategy.
Lina Nguyen is the Marketing Director for Saint-Gobain Life Sciences Medical. She has been with Saint-Gobain for over six years in various Strategy and Marketing leadership positions. Prior to joining Saint-Gobain, she spent seven years at General Electric. She enjoys running, traveling, and spending time with her niece and nephews.
