Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates
From FDA to MHRA: are drug regulators for hire?
Tag: vaccine manufacturers
Why India did not allow Pfizer’s Covid-19 vaccine
Why India did not allow Pfizer’s Covid-19 vaccine
In Latin America pharmaceutical bullying went a notch higher. In addition to legal indemnity, Pfizer demanded protection against their own negligence and mistakes. Argentina amended its vaccine law, three times, yet Pfizer was not happy. Pfizer wanted Argentina’s bank reserves and military bases as “guarantees”.
In the era of neo-colonialism, Pharma industry was the new East India Company.
…
Despite such pressure, India did not succumb. Eventually, Pfizer withdrew its application in 2021 We continued our vaccine programme with drugs that complied with our legal requirements.
[2017] Why vaccine manufacturers are exempt from liability
In 1986 Congress passed the National Childhood Vaccine Injury Act (NCVIA), creating a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related lawsuits and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too difficult and cost prohibitive.
Why vaccine manufacturers are exempt from liability
[2020] You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either
You also can’t sue the Food and Drug Administration for authorizing a vaccine for emergency use, nor can you hold your employer accountable if they mandate inoculation as a condition of employment.
…
In February, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act. The 2005 law empowers the HHS secretary to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments, unless there’s “willful misconduct” by the company. The protection lasts until 2024.