Blame the FDA. It’s a staple of industry communications that when a company receives a complete response letter. And it’s easy to do since such communications are “commercial confidential.” Not that the agency doesn’t often deserve blame – but there are generally two sides to every story and complete response letters are rarely (if ever) released to the media by the recipient.
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.
Which brings us to the issue of “spin.” Since the sponsor controls what is and is not shared, the sponsor controls what is and is not known.
And let’s face it, that can quickly slip/slide into spin. At a certain point the sponsor has to make a tough call – is less information better? There’s no hard and fast rule. Yet.
Yesterday, the FDA’s Transparency Taskforce recommended that the agency release more information about medical products and foods, including letters sent to companies about whether a product is approved or rejected. That’s right – the public release of complete response letters.
Another recommendation calls for the FDA to release safety information in cases where companies withdraw an application for a drug or medical device and a third suggests the agency release information about drugs for rare diseases, known as orphan drugs, in cases when the application was withdrawn for business reasons and not safety reasons. The agency could state that the proposed drug, if approved, would represent an advance for the treatment of a particular disease.
Don’t like these ideas? Blame the FDA? Perhaps. But the fault, dear Brutus …
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.
Which brings us to the issue of “spin.” Since the sponsor controls what is and is not shared, the sponsor controls what is and is not known.
And let’s face it, that can quickly slip/slide into spin. At a certain point the sponsor has to make a tough call – is less information better? There’s no hard and fast rule. Yet.
Yesterday, the FDA’s Transparency Taskforce recommended that the agency release more information about medical products and foods, including letters sent to companies about whether a product is approved or rejected. That’s right – the public release of complete response letters.
Another recommendation calls for the FDA to release safety information in cases where companies withdraw an application for a drug or medical device and a third suggests the agency release information about drugs for rare diseases, known as orphan drugs, in cases when the application was withdrawn for business reasons and not safety reasons. The agency could state that the proposed drug, if approved, would represent an advance for the treatment of a particular disease.
Don’t like these ideas? Blame the FDA? Perhaps. But the fault, dear Brutus …
