As we barrel down the pike towards deployment and mandates involving yet more inadequately tested, Emergency Use Authorized genetic vaccine products, it seems an appropriate time to review the law concerning marketing of unlicensed medical products.
This is all about reducing the risk of hospitalization and death from Omicron BA.5, which (based on data from all over the world) appears to be most significant in the highly genetic "vaccinated" population.
The FDA and CDC appear to have conceded that these vaccines are unlikely to do much for even slowing down infection, replication, and spread of this virus.
And in the opinion of many (including myself), these new products may well supercharge the development of even more sophisticated "vaccine escape mutant" viruses.
AXIOS: FDA authorizes Omicron boosters
The updated shots, retooled to target the BA.5 strain that accounts for most cases in the U.S. today, are expected to become available after Labor Day.
They are also the first to move ahead without an FDA advisory committee weighing in, marking a shift that more closely mirrors the annual flu shot approval process.
What does US Federal and Canadian law have to say about marketing of unlicensed healthcare products?
In Canada, Section 9(1) of the Food and Drugs Act states that, “no person shall label, package, treat, process, sell, or advertise any drug in a manner that is false, misleading, or deceptive or is likely to create an erroneous impression regarding its composition, merit or safety."
Similar provisions are laid out in the US Code of Federal Regulations (CFR), Title 21, section 312.
The promotion of any investigational drug or medical device is expressly prohibited.
Why the promotion or advertising of unlicensed healthcare products is prohibited
Scientific Information: Medical conferences and continuing medical education
21 CFR 213.7(a) recognizes that the prohibition of promoting investigational healthcare products is not intended to restrict the full exchange of scientific information concerning such a product, including presenting scientific findings in scientific or lay media.
To ensure compliance, companies may establish internal programs, procedures, and policies that follow industry guidelines.
Clinical investigation
When a new drug or medical device, or a new use of a licensed product, is under investigation, any claims of safety and effectiveness about such healthcare products are prohibited unless the company is seeking to recruit clinical investigators or enroll patients in a study.
Permissible activities may include: institutional ads, coming soon advertisements, information and promotion, and information and information about the product.
"Hope" is apparently the new normal at HHS under this administration
Personally, I prefer science and evidence based medicine and public health policies.
But for now, hope is apparently what is the New Normal at HHS
https://rwmalonemd.substack.com/p/promoting-unlicensed-vaccines-is?utm_source=substack&utm_medium=email
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