Bio­phar­ma ex­ecs rou­tine­ly shun re­veal­ing the hard truth when it comes to RTFs. And some peo­ple at the FDA think that's a big prob­lem

With­in drug de­vel­op­ment cir­cles, there’s noth­ing quite as em­bar­rass­ing as a refuse-to-file let­ter from the FDA. So it’s prob­a­bly no big sur­prise to hear that the av­er­age bio­phar­ma out­fit prefers to hide un­der any avail­able rock be­fore frankly ex­plain­ing what de­railed their ap­pli­ca­tions right from the start.

FDA staffers took a close look at 103 RTF let­ters — out of 2,475 ap­pli­ca­tions, or 4% of the to­tal — that were sent pri­vate­ly to drug de­vel­op­ers, count­ing 644 rea­sons why the agency barred the door to a new drug ap­pli­ca­tion. The agency’s hands are tied on pub­lic dis­clo­sures, though, leav­ing it to the com­pa­nies to of­fer an ex­pla­na­tion. And that has left com­pa­nies free to ei­ther pub­licly ig­nore what hap­pened, or sim­ply mis­lead peo­ple about the set­back.

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