Some interesting tidbits from the FDA’s June 24th meeting on the issue of transparency.
“FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions.” -- PhRMA Assistant General Counsel Jeffrey Francer. As an example, Francer pointed to FDA approval decisions that do not track with advisory committee recommendations. "That's often confusing, not only to those of us in industry, but people generally."
Absolutely. But, since transparency cuts both ways, wouldn’t it be equally beneficial for pharmaceutical companies to proactively release complete response letters received from the agency once a final action has been taken?
Transparency thrives in an atmosphere of clarity. And that was also a topic of conversation.
BIO’s Director for Science and Regulatory Affairs Andrew Emmett, commented that the FDA does not meet and communicate with firms on a consistent basis early in the development and review process. He urged, and appropriately so, that the agency work with industry to minimize barriers to such meetings.
Emmett also called for the agency to provide more information so industry can understand how FDA makes decisions. There needs to be "regulatory transparency and clear articulation of FDA's policies and expectations."
Since it can take several years for FDA to finalize guidance, "This leaves companies to ascertain FDA policy by interpreting the agency's regulatory decisions and enforcement actions, which is an inefficient way for industry to understand and meet the agency's regulatory expectations."
If we’re going to go “open kimono” on this, then the real 800 pound gorilla in the room is the fact that many inside the FDA prefer to leave guidances in draft form – because that ambiguity gives them almost unlimited and perpetual power. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.
FDA transparency cannot be achieved without FDA predictability. Predictability is power in pursuit of the public health.
On a related note (and at a different venue – the annual DIA meeting in San Diego), Sandy Kweder (Deputy Director, FDA Office of New Drugs) and Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) discussed the need to begin REMS conversations as early as Phase II. Dal Pan commented that "REMS are as new for us] as they are for all of you. It's not that we hold some secret and we're just not telling anybody about it. We're all navigating through this and trying to figure it out.”
