united-states medical vaccination emergencies
Is it legally possible to bring an untested vaccine to market (in USA)?
<p><a href="https://www.youtube.com/watch?v=CquiSjgJNc8" rel="nofollow noreferrer">Here</a>  Neil DeGrasse Tyson says there was testing and a system in place assuring the safe production of the new vaccines. He addresses people who have claimed there was no testing. That got me curious about the process so I did some research. Looking to fill in some gaps.</p>
<p>Could the new mRNA vaccines have come to market without any testing? I keep hearing claims that the new Covid vaccines weren't tested before being brought to market, and that there's a law eliminating all liability, both criminal and civil, in the emergency situation. Lacking legal incentives to test, Pfizer, Moderna, and the rest did not, so it is claimed.  My own research suggests otherwise, perhaps on a technicality, but I'm no lawyer.</p>
<p>Best I can tell, limited liability for vaccine manufacturers comes from the 2005 law <a href="https://en.wikipedia.org/wiki/Public_Readiness_and_Emergency_Preparedness_Act" rel="nofollow noreferrer">PREPA</a>. It still allows for prosecuting &quot;willful misconduct&quot;. Am I right to take that to mean criminal liability is still on the table? From what I can tell, an effort is made to rein in what qualifies as &quot;willful misconduct&quot; which could potentially reduce even criminal liability to nothing.</p>
<p>It's also been said that those potentially hurt by an emergency vaccine have no recourse when injured. From what I can tell, they may have no legal recourse but VICP and CICP of <a href="https://en.wikipedia.org/wiki/Healthcare_Systems_Bureau#Compensation_programs" rel="nofollow noreferrer">The Healthcare Systems Bureau</a> will compensate people. This happens rarely and with a pittance, so arguably doesn't exist.</p>
<p>If there are no legal consequences, what reason would pharmaceutical companies have to conduct clinical trials before going to market? A gesture of good faith?</p>
<p>I can't tell if companies are legally required to test before going to market. Is there a specific law about that?</p>

<blockquote>
<p>Could the new mRNA vaccines have come to market without any testing?</p>
</blockquote>
<p>No.</p>
<p>The FDA still has to approve emergency limited approvals of new vaccines. At least as a practical matter, the FDA requires some testing to grant this approval, although not the full testing regime of a non-emergency application for a new vaccine or drug approval.</p>
<p>FDA approval is the limiting principle that prevents emergency drug approval from being used recklessly despite a lack of civil liability.</p>
<p>I know this from news reports about the COVID vaccine approval process and can't cite chapter and verse of the relevant statutes.</p>
<blockquote>
<p>If there are no legal consequences, what reason would pharmaceutical
companies have to conduct clinical trials before going to market?</p>
</blockquote>
<p>Drug companies have to get FDA approval for every single product they make. If they act in bad faith to get emergency approval, the FDA will not treat them well in the future and could even revoke their authority to manufacture any drugs going forward.</p>
<p>Also, keep in mind that vaccines are not particularly high profit margin products for drug companies.</p>

<p>No. If you plan to sell any pharmaceutical products in the US, you have three choices.</p>
<ol>
<li>Go through the FDA's <a href="https://www.fda.gov/drugs/types-applications/new-drug-application-nda" rel="noreferrer">New Drug application</a> process.</li>
<li>Sell it without FDA approval, which is a felony. You risk going to jail for a long time and paying a hefty fine.</li>
<li>Give up on the US market altogether. But most significant markets have an equally onerous process.</li>
</ol>
<p>BTW, the FDA aren't stupid, or willfully obstructive, whatever snake-oil merchants might claim. If urgency is justified, there are mechanisms such as the <a href="https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products" rel="noreferrer">Orphan Drug Program</a> to expedite development and approval.</p>
