Pharm Exec Q&A: Inside View - Pharmaceutical Executive

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Pharm Exec Q&A: Inside View


Pharmaceutical Executive


At one point the survey combines two separate questions—one about separating the safety and efficacy functions at FDA, and the other about FDA strengthening its post-market product safety systems. Did you worry that this would be confusing?

When we created these questions, we worked very closely with a number of FDA scientists, former and current, and they were fine with that wording. They came up to us with that issue and said, you know, "This is a big concern." So that is where the wording came from. I don't think we loaded it in any particular way.

But it could be confusing.

It is. It's two themes. Obviously you get better information if you can separate these sorts of things, but we didn't have unlimited length in the questionnaire. In our minds the question was not just product safety but post-market product safety. That's what we were trying to get to.

The other thing to be clear on is that this does not come out in a vacuum. There's been a lot of hue and cry from a lot of sources, which had raised the issue of post-market product safety systems.

We were talking about what you feel were the most important questions.


The INTEGRITY of the scientific work produced by FDA could best be improved by...
Another is the question that asked whether the laws regulating FDA and FDA's structure needed to be changed. There, 63 percent agreed or strongly agreed. These scientists are feeling like there's a need for change.

The other very important questions I think have to really do with resources. This is not typically an issue for us at UCS, but we're hoping that other people will see this and realize that FDA currently does not have the resources it needs to really do its job. I mean, some of the essays say things like, "We just need a centrifuge." It feels like this agency has really been starved for money.

How do you look at numbers like these and determine what's appropriate and what's inappropriate? How do you determine what people really mean?

I'll just sidetrack for a minute to an analogy. Let's pretend that we had a university with 13,000 employees, which is approximately what we have at FDA. If 497 faculty members at that institution said the university was not moving in the right direction, there would be an enormous hue and cry. I think that's what we're trying to point out here—that the significant worker bees, if you will, are telling us they have concerns.

One question asks respondents whether they agree with the statement "I have been asked explicitly by FDA decision-makers to provide incomplete, inaccurate, or misleading information to the public-regulated industry, media, or elected senior government officials." Some people would say that FDA always provides incomplete information.

Well, there are several different ways of thinking about incompleteness. I don't think anybody would call results that were simply edited down incomplete. I don't think a reasonable person reading this would think, "Oh, we left out that paragraph about some minutiae of some particular drug and so therefore it's incomplete."

Should FDA reveal all its findings?

We feel that there is an enormous amount that is currently not being released that should be. What we find particularly worrisome right now is that the scientists don't feel like they can speak out when they have something to say that is in disagreement with approval. This gives them great pause. Several questions ask scientists whether they fear retaliation for positions they take. Those numbers should be zero.


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