Whichever party wins the White House in 2008, one truth will prevail at FDA – regulators love ambiguity but can learn to embrace predictability.
A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will make its decisions based on the facts.
What might change, depending on who occupies the White House and the FDA Commissioner’s Office, is how the FDA views the concept of time. And it could go either way --because there is real time and there’s FDA time.
There’s an old Washington story that goes like this -- Henry Kissinger asked Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, to which Chou responded: "It's too early to tell."
Chou would have made a great regulator.
Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us. FDA time is the time it takes to get it right (PDUFA notwithstanding) and, unless there's a trebling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectivenessâ€) is through collaboration with academe, with industry, and with hybrids like Ray Woosley's Critical Path Initiative.
Will collaboration continue to be embraced by the next President? By the next FDA Commissioner? This is the crucial question.
A related core issue is predictability – the opposite of ambiguity.
Predictability is power in pursuit of the public health. A case in point is the Critical Path initiative and the ways it can reach out and work with non-government partners via the imminent Reagan-Udall Center (pending in still pensile legislation). But ambiguity is bureaucratic power – and too many regulators accept ambiguity as a replacement for responsibility..
(I also believe that too many folks at pharmaceutical companies accept ambiguity as a replacement for responsibility.)
The coming election, relative to the future of the FDA, is a battle between nascent predictability and insidious ambiguity. So, here’s my idea for a bumper-sticker – “I support the FDA and I vote.â€
A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will make its decisions based on the facts.
What might change, depending on who occupies the White House and the FDA Commissioner’s Office, is how the FDA views the concept of time. And it could go either way --because there is real time and there’s FDA time.
There’s an old Washington story that goes like this -- Henry Kissinger asked Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, to which Chou responded: "It's too early to tell."
Chou would have made a great regulator.
Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us. FDA time is the time it takes to get it right (PDUFA notwithstanding) and, unless there's a trebling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectivenessâ€) is through collaboration with academe, with industry, and with hybrids like Ray Woosley's Critical Path Initiative.
Will collaboration continue to be embraced by the next President? By the next FDA Commissioner? This is the crucial question.
A related core issue is predictability – the opposite of ambiguity.
Predictability is power in pursuit of the public health. A case in point is the Critical Path initiative and the ways it can reach out and work with non-government partners via the imminent Reagan-Udall Center (pending in still pensile legislation). But ambiguity is bureaucratic power – and too many regulators accept ambiguity as a replacement for responsibility..
(I also believe that too many folks at pharmaceutical companies accept ambiguity as a replacement for responsibility.)
The coming election, relative to the future of the FDA, is a battle between nascent predictability and insidious ambiguity. So, here’s my idea for a bumper-sticker – “I support the FDA and I vote.â€
