With both the FDA Commissioner and CDC Director now promoting COVID vaccines off label, have companies been greenlighted to violate the law?
UPDATE: After this story published, Nature Magazine placed a comment at the bottom of their news article: Clarification 10 January 2024: This story now includes the fact that Jessica Snowden has served periodically as a paid member of a Pfizer advisory board.
During his first stint as FDA Commissioner during the Obama administration, Dr. Robert Califf proposed allowing companies to advertise their products off-label. This marketing practice is illegal under FDA’s regulations that cover drug advertising, and Dr. Califf received pushback from Senator Ed Markey who sent him a stiff letter demanding that he address off label use of opioids.
“The FDA must not become complicit in the growing prescription fentanyl problem this country is combating,” Senator Markey wrote. Indeed, Pfizer pled guilty to a U.S. criminal charge and paid a record $2.3 billion in 2009 for illegally marketing over a dozen drugs off label. Multiple federal agencies investigated Pfizer at that time, including the FDA’s Office of Criminal Investigations (OCI).