Do “complete response” letters offer more clarity or ambiguity? It depends who you ask.
If you are privy to what the letters say, they offer greater clarity as to what needs to be done to gain FDA approval. (At least that’s the theory.)
If you are a reporter or a financial analyst or a patient or a physician, you only know what the sponsor tells you. And that’s not much.
But it never has been and a lot of people find that frustrating.
Well, life is full of frustrations.
Consider the media. They have a job to do. Will complete response letters help them write a more complete story? No, because the letters are not public and it is highly unlikely (for many good reasons) that "commercial confidential" communications with the FDA will be shared with anyone outside the confines of the sponsor. (For more on the issue of complete response letters and commercial confidentiality, see, “Public or Private,” from the Journal of Life Sciences.)
Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.” Hogwash.
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. Easier said than done? Sure. But let’s stop with the lame “We’ll make FDA angry” excuses.
The strange silence that generally accompanies FDA communications is a tough nut to crack. If “more” is desirous by the media, but problematic from the legitimate viewpoint of the sponsor, what can be done?
One incremental step forward is to help clarify what is not in a complete response letter. Recently Johnson & Johnson received a complete response letter for paliperidone palmate. In addition to the usual and customary, “We’re looking forward to working with the FDA to bring this important new product to market,” J&J also added one important piece of information – that the FDA had not asked for any additional studies.
Rather than sharing what was in the letter, J&J shared what was not in the letter. Smart.
For more discussion of the complete response issue have a look at this excellent article from the July/August 2008 issue of the RPM Report.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
