This brings up some good thoughts here, why not have the FDA be a bit more transparent and issue the letter instead of the company denied. It could certainly ease some of the speculation and guess work in the long run and might even lessen some Congressional investigations if it were available up front. BD
When the FDA gives a thumbs down to an experimental drug, we hear about it from the drug company, which duly puts out a press release giving the bad news a rosy spin. Companies often disclose only a few details about the reasons behind the FDA's decision to reject or delay a drug application and there's nothing the public can do to learn more, because the letters the FDA sends explaining its decision are confidential under federal law.
FDA’s Jenkins has the following advice for the curious: “One thing I’ve said now for several years is, if a company is telling you about the letter, I would ask to see the letter, because that’s the only way to know what the FDA said.”
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