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

Bioregnum Opinion Column by John Carroll

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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