Three years and 1 million lives later, America’s struggle with COVID-19 is mostly in the rearview mirror. Therapeutics and vaccines developed to fight the coronavirus have saved countless lives and will remain critical tools for many decades. However, the Food and Drug Administration remains wedded to an unpredictable approval process (known as “Emergency Use Authorization” or EUA) that pursues opaque and ad hoc decision-making over efficiency and consistency. It’s time for the FDA to embrace a more expedited approach that allows innovators to test new treatments with minimal cost and uncertainty. With the right regulatory tools, the U.S. can build on its successes against COVID-19 and take the fight to deadly diseases.
Before the advent of treatments and vaccines to fight COVID-19, seeing friends and loved ones was a harrowing and frightening ordeal. Even after therapeutics such as Paxlovid hit the shelves, millions of Americans already taking other drugs (e.g., immunosuppressive regimens) were warned by their doctors not to mix medications. Fortunately, these high-risk patients could be treated using monoclonal antibodies without the risks posed by medications such as Paxlovid.
These man-made proteins work wonders by targeting specific viruses or cancer cells and attaching themselves to them. Once these “designer antibodies” are bound to their targets, the virus is neutralized, and the body’s own immune system is flagged to finish the job. The problem is that COVID-19 has constantly changed over the past three years, and monoclonal antibodies are not nearly as effective in dealing with newer coronavirus variants such as Omicron. In response, the FDA began revoking EUAs for the six monoclonal antibody treatments it had greenlighted to treat the deadly disease. In December 2022, the agency yanked the last authorization on the market (for bebtelovimab), stating the drug was “not expected to neutralize Omicron subvariants,” which by then accounted for the majority of injections.
Despite COVID-19 variants becoming progressively milder, news of this final revocation was a bitter pill for patients to swallow. Cancer-stricken patients were suddenly told they’d have few treatment options if they had the misfortune of contracting the coronavirus. While the FDA’s decision hewed to the data, the EUA process followed by swift revocation sent all the wrong signals to producers. Emergency authorizations are a minefield of uncertainty and can run the gamut from swift “approvals” with minimal disclosures to a full-blown approval process with multiple clinical trials. Treatments for COVID-19 usually fall into the latter category, entailing a lengthy, costly effort at a time of great desperation.
While this deliberative and time-consuming process makes sense for first-in-class medications such as novel mRNA vaccines, mandating a heap of clinical trials for each new iteration of monoclonal antibodies squeezes the pipeline of promising cures. And, for all that time and effort, the FDA can yank EUAs in one fell swoop. Drug companies rightly perceive that, if they focus their efforts on drugs targeting more “predictable” maladies, they can secure accelerated approvals without having to worry about their drug suddenly being pulled from the shelves. Even when the FDA does identify issues with already-approved drugs, it typically takes years and plenty of back-and-forth before an approval is rescinded.
Surely, there can be a happy medium for manufacturers of low-risk medications who are simply “updating” their regimens to target the latest version of a deadly disease. Instead of repeatedly going through the EUA process, these producers could pre-register with the FDA and have the agency verify the company’s track record in using data to upgrade previous versions of their therapeutics. Once the producer has earned the FDA’s trust, they could gain approval for future upgrades without having to disclose a treasure trove of data each time. Once approval is obtained, the FDA would reserve the right to remove these new medication versions, but only after a hearing process with the company and panel deliberations.
The FDA has already started using this “pre-certification” strategy for machine learning in software and digital therapeutics. For medical device approvals, the agency allows for a more flexible regulatory approach if device makers can show that their product are “substantially equivalent” to an already-approved device. Regulators can extend this flexibility to lifesaving drugs that are improvements to others already on the market.
With this new approach, innovators can reduce COVID-19 deaths even further and get a head start fighting the next pandemic.
David Williams is the president of the Taxpayers Protection Alliance.
Using these vague “policy violations,” Google is now threatening to demonetize us. It’s part of Big Tech’s effort to silence conservative voices.
I have not read the article yet, but my first thought is that to fight the next pandemic, we need a truly independent and ethical FDA. Employees need to be precluded from going on to the employ of any pharmaceutical company. The agency itself needs to receive its funding for the taxpayers and NOT from the pharmaceutical companies they are supposed to be providing oversight of and randomized control trials need to be conducted by independent entities. They should not know what company is looking to get the drug approved; their only task is providing evidence of its efficacy and its safety, and the FDA should, prior to authorization, release the data to the public to be independently scrutinized.
What you proposed is essentially the way that new versions of existing vaccines are approved. The new annual formulations of flu vaccines are not tested each year in large clinical trials before release; neither were the follow-on versions of COVID vaccines; and nor will the newest versions of the COVID vaccines, as long as they use the previously validated platforms.
Help refresh my memory because I must have missed something ~ exactly what were our “successes” against COVID again? Pretty much everything they told us and then mandated were disastrously false, or outright lies. And the supposed “vaccines” only inoculated you from the COVID cancel culture and made you one of “the good guys” and therefore eligible to live in civil society, but they did nothing to actually stop COVID. But they did manage to guilt and shame a majority to inject themselves with an unproven and untested shot that seems to be evolving as the months go on, causing countless damage to the human body. Those “man-made” proteins are reeking havoc on peoples natural body systems, they are not helping. If anything, the body is trying to reject, unsuccessfully, these proteins as ‘invaders’ but the mRNA gene therapy is overriding our natural bodily function. So forgive me if I can’t seem to remember what the “successes” are . . . .
Is your comment intended as some sort of parody? Every assertion in it is inaccurate, idiotic, and/or paranoid. To take just two examples, (1) the two mRNA vaccines were tested in randomized, double-blind clinical trials of about 30,000 subjects each before becoming available under Emergency Use Authorization, and they were tremendously successful; and (2) according to an analysis by the Commonwealth Fund, “Two Years of U.S. COVID-19 Vaccines Have Prevented Millions of Hospitalizations and Deaths (https://www.commonwealthfund.org/blog/2022/two-years-covid-vaccines-prevented-millions-deaths-hospitalizations).
Provide the study of the 30,000 and their findings and who financed and conducted the study? Please, no pharmaceutical backed studies. There is so much vaccine injury that I find it hard to believe that there was any thorough honest human testing that didn’t expose the high rate of dangerous side effects. And many side effects are still presenting years after vaccination.
Here’s the one for the Moderna vaccine: https://www.fda.gov/media/144434/download. There’s an analogous one for the Pfizer vaccine. (I’ve read both of those but not the one for the J&J vaccine.) You obviously know nothing about drug and vaccine trials: Except for a very small number done by NIH, clinical trials for new drugs and vaccines are all performed by drug companies, and the results are carefully audited and evaluated by the FDA. As for your claim of “so much vaccine injury,” you’re delusional. Get professional help.
So VAERS is delusional? Got it. And all those suffering from very real physical vaccine injuries are delusional too? Got it. I guess reality is delusional. So is your measure of “success.” I get that you are a supporter/promoter of these shots and care little if any about the suffering of many around the world. Your condescending comments make that all to clear.
Among many, many other things, you don’t understand VAERS. This is from the CDC (https://www.cdc.gov/vaccines/hcp/patient-ed/conversations/downloads/vacsafe-vaers-color-office.pdf): “Reports of adverse events (possible side effects) after vaccination do not mean that the reported problem was caused by a vaccine. Reports are signals that alert scientists of possible cause-and-effect relationships that need to be investigated.” Good luck. You’re going to need it.
I understand a lot, it’s you that deny the obvious. Hundreds of thousands of people are reporting a host of side effects ranging from minor to life threatening after this getting the COVID shot. You have faith in the CDC, the FDA and big Pharma that they would “do no harm” and the are infallible. Those of us living with their failures know better. Conformity suits you and your condescending demeanor. Good luck with that.