The Declining Standards of FDA Drug Approvals
The U.S. Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people. But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline. The Need for Speed Since the enactment of […]
Robert Califf Heads FDA Again Despite Financial Ties to Pharma
Robert M. Califf, MD was confirmed by the U.S. Senate to be commissioner of the Food and Drug Administration (FDA) by a vote of 50-46 on Feb. 15, 2022. Dr. Califf’s financial ties to the pharmaceutical industry was cited by some Senators as a reason they could not support his appointment. Similar concerns were expressed […]
Former Pfizer Employee Whistleblower Alleges Falsified Data in COVID Biologic Trial
A former testing site researcher in Texas has alleged that Pfizer’s pre-licensure BNT162b2 (also known as “Comirnaty”) COVID-19 biologic trials included falsification of data, unblinding patients, employing inadequately trained vaccinators, and delays in following up on experimental COVID vaccine adverse reaction reports.1 According to clinical trial researcher Brook Jackson, the incidences occurred during the phase […]
The FDA Has a History of Rushed Drug Approvals
Two weeks ago, the Pfizer COVID-19 vaccine was reported as the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA) for individuals aged 16 and older.1 But, for some, questions remain regarding conflicting discrepancies of the wording surrounding the approval.2 While the FDA’s report states that full approval was […]
