New study of FDA cites the flaws be­hind rapid-fire can­cer drug OKs

Over the past few years the FDA’s on­col­o­gy group un­der Richard Paz­dur has tru­ly rev­o­lu­tion­ized the way can­cer drugs are de­vel­oped and re­viewed for mar­ket­ing ap­proval. In or­der to ramp up the ar­rival of new drugs, reg­u­la­tors waived old rules on over­all sur­vival, flag­ging their will­ing­ness to carve years out of the R&D process in or­der to field new ther­a­pies.

It was a straight up trade off. The FDA was will­ing to ac­cept pre­lim­i­nary ev­i­dence of ef­fi­ca­cy and safe­ty and de­lay con­fir­ma­to­ry stud­ies un­til af­ter a drug was on the mar­ket. And pa­tient groups have cheered the FDA on at every turn.

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