KW - Your body of work is not very good, it is EXCELLENT. Keep fighting the good fight.
If Pfizer was regulated by HHS under PHSA or FFDA, they are home scot free. If NOT then the higher three point standard of willful misconduct could apply. Wish in one hand and... as you know...
Willful misconduct CANNOT be found against:
A manufacturer or distributor for actions regulated by HHS under the Public Health Service Act or the Federal Food, Drug and Cosmetic Act, if HHS chooses not to take an enforcement action against the manufacturer or distributor, or if HHS terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty;
The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of ‘‘Covered Countermeasures’’ and ‘‘qualified pandemic and epidemic products’’ in Section 319F–3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.
Sorry if you have seen this before. 2005 George Bush:
"On November 1, 2005, I announced the National Strategy for Pandemic Influenza, a comprehensive approach to addressing the threat of pandemic influenza. Our Strategy outlines how we are preparing for, and how we will detect and respond to, a potential pandemic."
KW - Your body of work is not very good, it is EXCELLENT. Keep fighting the good fight.
If Pfizer was regulated by HHS under PHSA or FFDA, they are home scot free. If NOT then the higher three point standard of willful misconduct could apply. Wish in one hand and... as you know...
Willful misconduct CANNOT be found against:
A manufacturer or distributor for actions regulated by HHS under the Public Health Service Act or the Federal Food, Drug and Cosmetic Act, if HHS chooses not to take an enforcement action against the manufacturer or distributor, or if HHS terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty;
https://aspr.hhs.gov/legal/PREPact/Pages/PREP-Act-Question-and-Answers.aspx
The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of ‘‘Covered Countermeasures’’ and ‘‘qualified pandemic and epidemic products’’ in Section 319F–3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.
https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf
Sorry if you have seen this before. 2005 George Bush:
"On November 1, 2005, I announced the National Strategy for Pandemic Influenza, a comprehensive approach to addressing the threat of pandemic influenza. Our Strategy outlines how we are preparing for, and how we will detect and respond to, a potential pandemic."
233 pages of what they are doing now.
https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-implementation.pdf