Floor and Committee Statements

Thursday, March 17, 2005

U.S. Senator Johnny Isakson (R-GA)
Hearing on the Nomination of Lester Crawford to Serve
as the Commissioner of the Food and Drug Administration
Health, Education, Labor, and Pensions Committee

Sen. Johnny Isakson (R-GA): Thank you, Mr. Chairman. First of all, Mr. Chairman, I'd like the record to reflect that Dr. Crawford has his Ph.D. in pharmacology from the University of Georgia. And further, serves as the head of the Department of Physiology and Pharmacology, which in and of itself should certify his complete competence to serve in this capacity.

I say that as a senator from Georgia, who's very proud of your nomination.

Mr. Lester Crawford: Thank you, sir.

Sen. Isakson: Following up a little bit on some of the questions, the Office of Drug Safety is a post-approval office, is that correct?

Mr. Crawford: That's correct.

Sen. Isakson: And it collects data from drugs that have been approved, from various sources, to determine whether there's a safety problem?

Mr. Crawford: That's right.

Sen. Isakson: How do you collect that data?

Mr. Crawford: What we do is, there are about three major sources. There are databases. For example, the Veteran's Administration has a very complex and very useful database where they keep records on adverse reactions and so forth. So do some of the HMO's, like Kaiser Permanente, the National Institutes of Health, and we tap into those databases.

The second thing is that there are scientific reports that appear in the scientific literature around the world. We comb through that. And then we receive adverse event reports each and every day of the year, and we compile all of those.

So those are the three main sources of information.

And then once we get one of those signals that something may be wrong, it's up to the Office of Drug Safety to evaluate whether it's a false alarm or the real thing.

Sen. Isakson: Is that collection system institutionalized within the agency or does someone just have the responsibility of going to these three sources and asking if they have information?

Mr. Crawford: No, it's institutionalized in the agency. There is an Office of Drug Safety, and I would say that, prior to 10 years ago, prior to 1995, it was not institutionalized.

But it was at that point and, gradually over the years, the funding and the number of people in that office, have improved both in terms of what they do, and what their expertise is.

And we are asking this year, in the president's budget, for more personnel. I think this is the biggest increase we've asked for. We're also asking for more funding for the office. And I'm taking a personal interest in it, and as is the rest of FDA's leadership.

Sen. Isakson: Is any of that collection electronic?

Mr. Crawford: Not as much of it as it should be. What we are working with -- I met with the secretary of Veteran's Affairs just recently, and what we are hoping to do is to get online with their medical databases.

We also want to do that within NIH, and I think we're very close -- but right now it's a little bit of both.

Sen. Isakson: Well, the reason I ask, and the question is, that life experiences are the best teachers. My sister's life was saved through a field trial where she was a volunteer and she had a very serious complex case with cancer.

And so I am fully an advocate of getting drugs to the marketplace and technologies as expeditiously as possible, for the benefit of those who suffer from terribly crippling diseases or other effects.

I'm equally committed to ensuring that we have good safety, and it seems to me like two things. One, drug safety ought to remain within the agency. If you get into sending it outside, that doesn't seem to make any sense at all except to maybe be symbolic of something that I don't think needs to be symbolized.

But second, it would appear to me that the timely collection from all sources of adverse affects or some commonality of reoccurrences of those on different drugs or taking different treatment, post-approval, would serve to be a great second certification of what a field trial in itself does from the beginning.

And I guess my comment is, I'm not really asking you a question, but after the two hearings I've attended on this, and conversations I've had, and my personal experience, it would seem like to me, if the department -- and it may be doing this -- could initiate or institutionalize electronic collection from all sources.

Veteran's Administration is a great source and you have great reliability in the information, but once you go beyond that, like Kaiser Permanente or an HMO, or maybe this drug program or that drug program, it seems to me like, it's probably as comprehensive as you can get, given what you have, but not as comprehensive as we probably ought to have.

And so I would hope you all would look towards initiating whatever you can to expedite the collection of all that data from its various sources, and I think then the post-safety process will be that much better and certainly that much more timely.

Mr. Crawford: Thank you.

Sen. Isakson: Spoken as one who has no degree in any chemistry or pharmacology, but just based on what I have heard. Thank you.