Will publicly released complete response letters become the first example of the FDA’s transparency initiative? That’s the buzz.
"We don't publish information when we don't approve a drug as to why we don't approve it, but that information clearly could have broad value," FDA Commissioner Peggy Hamburg.
Whether or not the FDA has the legal jurisdiction is certainly open to debate – but it’s becoming increasingly clear that the agency thinks it does. And many inside certainly want to:
Here it is straight from the Bob Temple:
“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”
Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency.
“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”
Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency.
Regulatory cognoscenti believe that such releases would have to be redacted to protect commercial confidential information. Makes sense – but who decides what’s commercial confidential?
If the FDA decides to opt for the “release is good for the soul” track, they should also declare their intentions that redactions are to be agreed upon mutually and done in an aggressive timeframe that coincides with the actual release of the complete response letter to the sponsor.
Transparency and fairness should not be – mutually exclusive.
