The Regulatory Watchcat
Emergency Use Authorization
Just to be sure there is no confusion here: The Regulatory Watchcat absolutely, positively HATES emergency use authorization. Yes, of course I can see how it might have sounded like a good idea at the time. Isn't that how these things always start?
EUA Ethical Issues
I started with a question, does use of EUA products violate Article 37 of the Declaration of Helsinki?
37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if, in the physician’s judgement, it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.
This in turn raised the questions of whether EUA products are proven or unproven, and if their use is medical practice or research.
This raised more questions and finally led me to the conclusion that EUA lies in an ethical gray area between constructs usually viewed as discrete, but which can instead be viewed as points on a continuum, e.g., medical practice and research, proven and unproven interventions, individual and public health, investigational and marketed products, product development and sales, premarket review and postmarket surveillance.
This raised yet more questions, which I have not yet begun to answer. What I have done so far is to collect resources like Article 37 of the Declaration of Helsinki that seem relevant to the questions.
As you can see from this website, I don't need any more projects in my lifetime, but ethical oversight and informed consent have always been important to me. So, out of all the pandemic-related issues I could have taken up, I decided to take up this one. I anticipate putting together a white paper on the subject and also some sample informed consents that I think would support ethical use of EUA products.
Click on the icon above to see what I've pulled together so far.
FDA will not tolerate inaccurate or misleading claims about COVID-19 tests. Meaning what, exactly?
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud. When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk. Such conduct will not be tolerated by the FDA..."
Jeff Shuren, MD, JD, FDA Press Release, June 17, 2020.
Maybe it's just me, but when the employees of a manufacturer and its subsidiary claim a device that has received emergency use authorization has been "approved," they are claiming that the test has been approved when it has not.
Everybody Pinkie Swears!
This was one of those extracurricular side trips the Regulatory Watchcat sometimes can't resist.
Watchcats don't like rats.
And they know one when they see one.