
IPFS News Link • Food And Drug Administration / F.D.A
'Normalization' Of Emergency Use Authorizations Concerns Health Experts
• https://www.zerohedge.com, by Marina ZhangBetween March 2020 and June 2021, more than 600 EUAs were authorized, according to Fortune.
This has caused concern among healthcare professionals, with some studies claiming that overreaction by regulators may have led to a decline in industry standards (1, 2).
As clarified in the journal Yale Medicine, "An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks. A EUA also only lasts as long as the public health emergency for which it was declared."
Prior to 2020, the public health emergency that allowed the highest number of EUAs was the 2009 H1N1 pandemic, with 22 EUAs overall for personal protective equipment (PPE), antivirals, and diagnostic tests. The only emergency-authorized vaccine prior to the 2020 pandemic was the anthrax vaccine.
Given the drastic increase in EUAs, experts worry that this time, the FDA has gone too far.
The Normalization of EUA Drugs and Lack of Informed Consent
Cardiologist Dr. Jack Askins has pointed out that the unprecedented onslaught of emergency authorizations in drugs, vaccinations, medical devices, COVID tests, and PPE has normalized EUA drugs and products as being fully FDA-approved rather than being investigational.
Prof. Linda Wastila from the University of Maryland School of Pharmacy, whose expertise is in pharmacotherapy and drug policy, told The Epoch Times that the torrent of 600 EUAs makes it very difficult for healthcare professionals to remain informed of the approval statuses of new drugs.