The sooner we give the medical professionals - who are treating patients - a voice and a vote in the FDA drug approval process, the better. Medical professionals have to state any conflicts of interest while an FDA director or CDER staff does not. The sooner we eliminate those that are bureaucratically linked to big pharma, and increase regulatory transparency, the sooner we can get innovative medicines to patients. 

How FDA Used Its Accelerated Approval Pathway Raised Concerns in 3 of 24 Drugs Reviewed

What OIG Found 
Our review identified concerns about FDA’s use of the accelerated approval pathway in 3 of the 24 drugs we reviewed:  
• For two of the three concerning approvals, FDA evaluated analyses not included in the sponsor’s (i.e., pharmaceutical company’s) original analysis plans, deviating from recommended practices. 
• FDA approved these three drugs despite concerns from its own reviewers and/or advisory committees. 
• For one drug, some meetings with the sponsor appeared to be missing from the administrative file and other meetings are not fully documented. 
Additionally, two of the three drugs that raised concerns are now off the market, and completion of the confirmatory trial for the third drug is delayed. 

Recommendation 1 - FDA should define specific factors that would require FDA’s accelerated approval council to advise on certain drug applications.

FDA Response - FDA does not concur with OIG’s recommendation. FDA would concur with having Center leadership, rather than the accelerated approval council. 

January 20th -
CDER Center Director Dr. Patrizia Cavazzoni (previously worked for Eli Lilly, Sanofi, and Pfizer)
CBER Deputy Center Director Dr. Celia Witten
CDER Deputy Center Director Dr. Douglass Throckmorton
former CDER Deputy Center Director Dr. Bob Temple
recently announced departures from FDA. 
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