Pharm Exec Q&A: Inside View - Pharmaceutical Executive


Pharm Exec Q&A: Inside View

Pharmaceutical Executive

What actions should FDA be taking here?

We don't do FDA. We do scientists. We don't want to prescribe the details of what FDA should do. Rather, we want to make certain that there's a process in which the scientific debate happens, the voices of the scientists are taken into account. That's what we think is the most critical aspect of this.

Roughly half of FDA's employees are scientists. And if you look at the agency's mission statement, it's very clear: protecting the public health, helping the public get accurate science-based information. It should be, in our opinion, very much a science-driven organization. Science is rarely the only thing taken into account when we create policy. We don't dispute that. What concerns us is when the science doesn't make it—free and unfettered—into a policy debate.

What has to happen to assure that scientists' voices are heard in policy debates?

Right now, as FDA transitions to new leadership, it's particularly important for that new leadership to come out and say, "We're not having this. We are, in fact, a science-based agency and we need to create some fairly significant structural changes to make sure that the voices of the scientists are heard."


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here