Memo details Høeg’s role in blocking Tzield approval

There has been a lot of talk about transparency at FDA over the past year and a half. Acting CDER Director Michael Davis has delivered, producing a memo for the record outlining how his predecessor repeatedly overruled career staff to quash a drug approval. 

Davis’s memo also calls into question the integrity of the commissioner’s national priority voucher (CNPV) process, highlighting how it empowered political appointees to overrule career staff without providing evidence or documentation to support decisions. Davis also contradicts former Commissioner Marty Makary’s assertion that drugs were selected for CNPVs based on nominations from review staff. ...