What Now?
I like old movies. One that has always intrigued me is Mike Nichols’ The Graduate, and the scene I like best is the ending shot when the protagonists, having escaped the constraint of social norms, are at first exuberant and then sober as they face an uncertain future.
With the federal government's emergency declaration “ending” around COVID that movie ending comes poignantly and immediately to mind. It also begs the question, “What now?”
Will the COVID vaccines still be "legal?" Will the tests still be available? Will anything really change, or will everything?
The answer depends on which law is being used by the government agency or speaker. Here’s something to help you understand it all.
Tracking, testing, treatment, prevention.
Two laws are all you need to know. The first is the Public Health Service Act (in particular section 319) and the second is section 564 of the Food Drug and Cosmetic Act. Sounds simple? It isn’t.
The PHS act is about certain powers and money. Money for tracking the pandemic, think academic websites and tracking tools available to the public for free diagnostics, like testing, free vaccines and more. The FD&C Act, is about allowing authorized medications, tests and things that have been developed to still be marketed and used without meeting the required criteria of approved products. I covered the difference in another blog posting, but I’ll oversimplify here using the testing example. For approval certain tests must meet a certain stringency for false negative and false positive results. It’s basically about safety, reliability, and effectiveness, and for most medications, tests, and more, a product must be approved to be sold and used in the US. Authorization doesn’t require the same stringency. In general, it is applied when the threat of a disease outweighs that lack of stringency met by the product.
Here's a made up, non-medical example to illustrate. Let’s say a life preserver has to stay afloat 99 percent of the time for a 140-pound person to be approved. However, a flood is coming, and we don’t have any of those. A local company makes life preservers that hold up 80 percent of the time. We normally wouldn’t use those but the waters are rising and so we decide it’s better than the alternative, so they are given the go and are authorized for use. This is an oversimplified example, but it isn’t too far off.
The question becomes, what happens when the flood is over, and we go back to the local river to swim for fun? Do we keep using the authorized preservers or only allow approved life preservers. Perhaps we feel like there could be another flood sometime soon, so do we continue to allow them?
That’s the question.
The PHS Act.
When most people refer to an emergency declaration or “the” emergency declaration, they are referencing the declaration by the U.S. Department of Health and Human Services (HHS) Secretary that a public health emergency exists under section 319 of the Public Health Service (PHS) Act.
Under section 319 of the PHS Act, the HHS Secretary can issue a determination (also referred to as a “declaration”) that a “public health emergency” (PHE) exists.
The declaration generally lasts for 90 days, but may be extended by the HHS Secretary. After each extension, the declaration lasts for 90 days or until the HHS Secretary declares the emergency no longer exists, whichever occurs first.
A section 319 PHE declaration does not enable FDA to issue EUAs, or Emergency Use Authorizations.
A section 319 PHE declaration allows HHS to take appropriate actions in response to the emergency consistent with other authorities, including: making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder. For a more comprehensive list of what this type of declaration can enable, see from HHS: Public Health Emergency Declaration.
The HHS Secretary issued a section 319 PHE declaration for COVID-19 in January 2020, and extended it every 3 months until May 11, 2023.
This is about money, and it is expiring.
The FD&C Act.
Separate declarations–sometimes referred to as “EUA declarations”—under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (also issued by the HHS Secretary) enable the issuance of EUAs.
Before FDA can issue an EUA, the HHS Secretary must declare that circumstances exist justifying the authorization. An EUA declaration is based on specific types of determinations, also under section 564 of the FD&C Act, of emergencies/threats or potential emergencies/threats by the Secretaries of HHS, Homeland Security, or Defense.
Unlike the section 319 PHE declaration that expires if not extended, an EUA declaration under section 564 of the FD&C Act generally continues until the HHS Secretary terminates it.
An EUA declaration is distinct from, and not dependent on, an HHS PHE declaration under section 319 of the PHS Act, and, therefore, an EUA may remain in effect beyond the duration of the section 319 PHE declaration if all other statutory conditions are met.
EUAs may remain authorized and new EUAs may continue being issued so long as the applicable EUA declaration and determination remains in effect.
The HHS Secretary issued a determination under section 564 of the FD&C Act (initially issued February 4, 2020, and amended March 15, 2023) that there is a public health emergency, or significant potential for a public health emergency, that affects or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus (nCoV) in 2019 (COVID-19). Based on the HHS determination, HHS issued 4 EUA declarations, for:
On March 17, 2023, HHS issued a notice that, effective March 15, 2023, the HHS Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (SARS-CoV-2).
The four previously-issued section 564 declarations that refer to the February 4, 2020 determination have not been terminated by the Secretary because, among other things, the circumstances described in section 564(b)(1) continue to exist—i.e., COVID-19, a disease attributable to SARS-CoV-2, continues to present a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad.
But I left my law degree at home. What does this really mean?
In short, the products will still be available even though they have not yet been approved as per the FD&C Act. The biggest difference is that now there won’t be any government money to pay for them as the PHS provisions will end. That means you will pay.
A question that still remains include, what is the incentive for a company to improve a product to meet approval, if they don’t have to? This is the first time we have seen something like this on this scale, but no one is actually talking about it. Maybe this posting will help.
The big what if.
Under the provisions, a potential threat, or the potential of the threat to national security, which is often indistinct, to US citizens abroad, and the public can be interpreted by the Secretary of Health and Human Services and the Commissioner of the FDA, and if they agree can allow for the issuance of an EUA that never ends unless they decide it should. This is different from the public health emergency which traditionally prevailed to cause the issuance of an EUA.
The question remains, what will this mean for the future? Will it allow a nimble and quick response should COVID mutate, which of course, it is? Or will it simply limit the pressure for certain product manufacturers to press for more refinement when they can market the product without doing so?
A lot depends on how we react. So, good luck.
With your Health in mind…
Be well!
Sources and more information:
