By Greg Daniels
The Biden administration has nominated Dr. Robert Califf to head the Food and Drug Administration. Peter J. Pitts, a former FDA Associate Commissioner, had published at the International Business Times an enthusiastic essay about Califf’s nomination because Califf is a proponent of accelerated approval for drugs. However, that one factor, while it can be beneficial, ignores myriad other problems with Califf.
You can read the IBT article here, which focuses on Califf’s approval history. This essay is about all the problems with the rest of Califf’s history.
COVID has revealed that the FDA, the CDC, Fauci, the White House, and “science” are at odds with each other. The FDA desperately needs major reform and transparency surrounding hiring, drug safety, and new drug approvals. As commissioner under Obama, Califf made few or no noteworthy changes to the FDA and shows no signs of improving the record if re-appointed.
Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data, but there is little evidence he achieved that goal…
