Pharm Exec Q&A: Inside View - Pharmaceutical Executive


Pharm Exec Q&A: Inside View

Pharmaceutical Executive

The first step, which takes the longest, is combing through an agency's personnel records looking at job descriptions and people's educational background to see who are the scientists. That took a long time at FDA because there were 13,000 scientists to go through. And we came up with the 6,000—actually 5,918—that we mailed to.

We mailed across the country to the seven centers in the Office of the Commissioner because we felt like it was important to see how this looked across the country. The differences among the centers were not even statistically significant.

Of the scientists who responded, 62 percent were GS13s to 15s. That's the top of the General Service schedule. And another 34 percent were GS9s through 12s. So we really had high-level scientists.

Thirty-three percent had been at the FDA more than 15 years, 19 percent had been there six to 10 years, and another 14 percent had been there between 10 and 15 years. So three-quarters of the people we surveyed had been there more than six years.

What FDA Insiders Say
People have been tempted to say, "Wow, these are just the angry or the malcontents." I think the best way to talk about that is to look at the essays. The information in them is the voices of scientists who are worried about safety and efficacy. It's not embittered people. It's people who are really committed to their jobs, committed to what they're doing at the FDA. In the course of the survey we had a lot of phone calls from scientists at the FDA because they were concerned and wanted to know if we were for real—who we were and was this for real or was it connected somehow to FDA leadership.

They want to find out if their bosses were spying on them.

I think that was a real concern.

There is the other side, though, that thinks you might be more of a political group than a group of concerned scientists.

Well, we are a 501(c)(3) organization, and anybody who's familiar with the IRS code concerning that knows that we are severely limited in the amount of lobbying that we can do. By law, it's a very, very small percentage of our budget. I'm not going to say we don't lobby. Obviously we do take advantage of that small portion, but I think it's only two percent of our budget.

Let's discuss the survey a little more. Which questions do you feel are the most important?

Some things come out very loudly. One is that the scientists are worried about what they can and cannot say. That's incredibly important, and I think the numbers support their concerns. In one question, for example, more than a third of FDA's scientists disagreed or strongly disagreed with the statement that they were free to express within the agency concerns about public health without fear of retaliation.

The second theme I think has to do with where we need to go from here. For example, we have 792 scientists agreeing that the public would be better served if the independence and authority of postmarket product safety systems were strengthened.


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here