Trying to read the FDA tea leaves

Did the COVID vaccines skirt FDA regulation through the Warp Speed process, using Janet Woodcock (then-head of FDA’s CBER, acting as the FDA’s liaison to Warp Speed) to give them a pass?

Following her Warp Speed role under Trump, Janet sashayed to become acting FDA Commissioner while hoping for the real Commissioner job.  But after her signature laissez-faire regulation, which licensed a $50,000/year Alzheimer drug Aduhelm that did not work and was not safe, came under scrutiny, she was bypassed.

Acting FDA Director Janet Woodcock, MD was required to be replaced after a year.  It actually took a bit more.  Then a former FDA Commissioner, who worked under Obama for about a year, Robert Califf, MD barely got confirmed due to FDA laxity with opioid manufacturers on his prior watch.

But Califf (who was working for Google at Verily before taking the FDA reins) did get the job, and rode in on his white horse in February 2022, claiming, 

I keep saying one of the mottos for me is ‘in God, we trust, everyone else must bring good evidence.’” —FDA Commissioner Robert Califf

https://www.fiercebiotech.com/biotech/califf-says-agency-needs-do-better-job-getting-post-market-data-accelerated-approvals

However, Dr. Califf lifted Janet Woodcock up on his white horse and gave her the deputy Commissioner role. After all, she knows where all the bodies are buried.  Maybe he thinks she can take the fall when the COVID disaster finally blows up.

All I can say is that since he became Commissioner in February, things at FDA have not been quite so lax. There have been no new authorizations or approvals for the COVID vaccines.  Meetings regarding the preschool age COVID vaccine authorization have been twice postponed.

Will he try to clean up the COVID mess or keep it at arm’s length?  Will he get rid of paxlovid and molnupiravir, the awful replacements for hydroxychloroquine and ivermectin that our government spent billions to purchase, at about $700 per course?

Stay tuned.

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