Pharm Exec Q&A: A Soft Spot for Whistleblowers - Pharmaceutical Executive

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Pharm Exec Q&A: A Soft Spot for Whistleblowers
FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive Pharm Exec interview, he explains where the agency goes wrong—and what he would do to fix it.


Pharmaceutical Executive


Is that too-close relationship with industry aggravated by FDA's increased reliance on user fees?

Well, there was a good purpose for putting user fees in place. About 15 years ago, the drug companies were complaining that FDA was moving too slowly. We came to the conclusion to speed it up, but had to have resources to pay for it. So we decided to let the drug companies pay for it. I'm willing to accept the idea that just because they're paying for it doesn't give them an inside.

You have proposed a separate drug-safety office, but FDA officials and others fear that such a move would shift the risk/benefit assessment too much to the risk side.

You get back to how the scientific process works. If scientists say a new drug is safe, they've got to have scientific evidence to back them up. When a drug goes on the market, the scientists in the Office of Drug Safety also have to proceed in a scientific way. In each instance there doesn't have to be any relationship—each group just has to do its job.

Do you think Congress will approve legislation on drug safety?

The Senate HELP Committee [Health, Education, Labor and Pensions] has a bill that is trying to accomplish many of the same things that I'm trying to accomplish. But I don't think they do it in the best way. They don't call for a separate drug-safety agency.

If some of the ideas I want to get accomplished don't [move forward], I would use almost any vehicle to get them accomplished. The legislation doesn't necessarily have to go exactly my way, but it has to accomplish the same ends.

No "facilitator," please

You mentioned that FDA needs permanent leadership, but you have not been very enthusiastic about the current nominee. Do you think the acting commissioner could address some of your concerns if confirmed?

I was disturbed by some reports we received that at an FDA meeting about Ketek, he [Andrew von Eschenbach] described the drug's approval as one of "our greatest hours." But this was a case where the scientists had raised all these safety questions, and someone higher up had overridden them. I also hear about him bragging about being a facilitator; anyone who sees himself as a facilitator for the drug companies is not looking out for John Q. Public the way he should.

Now—will I vote for him or against him? I don't have my mind made up on that. But I will say this: I've had several meetings in my office with him where it seemed to me that, yeah, he's the guy who has the right attitude. But then I hear rumors about what I just described to you, and it raises questions about pandering.

The main issue holding up von Eschenbach's confirmation is that FDA has moved too slowly to approve broader access to the morning-after pill. Do you see evidence of politics interfering with FDA deliberations?

Even though I might agree with the [interference of] politics, I would have to turn it around and say that I'd have to apply the same standard to that as to anything else. If the scientific process has played out and safety and efficacy is proven, I can't have two standards of science—one for a drug I might agree with and one for a drug I don't agree with.


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