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.
When Biden chose Dr. Califf to run the FDA a second time in 2021, The New York Times reported that Obama officials had actually killed Dr. Califf's attempt to allow increased off label promotion.
A week before the Christmas break, Commissioner Califf posted a message on X, promoting COVID vaccines off label to allegedly protect children against long COVID. "The FDA-approved and authorized coronavirus vaccines are indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2," an FDA official emailed me.
"The vaccines are not approved or authorized as a treatment for long COVID." In follow up email, FDA clarified that the COVID vaccines are also not approved or authorized to "Prevent" long COVID. In his promotional post on X, Commissioner Califf linked to a news article in Nature Magazine as proof the vaccines prevent long COVID. And here's where the story gets even weirder.
While the CDC's small observational study is expected to be published in a peer reviewed journal in coming months, Nature's news piece promoting the CDC's findings somehow caught the attention of CDC Director Dr. Mandy Cohen, who then posted it on X. I then sent an email last week to the CDC asking why Director Cohen was promoting the COVID vaccines for off label use, and whether any CDC Director has done so in the past.
Pfizer's payments to Dr. Jessica Snowden can be found in the federal government's Open Payments database, which notes the company paid Dr. Snowden to give 4 marketing talks promoting their Comirnaty COVID vaccine.
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