Floor and Committee Statements

Thursday, March 3, 2005

U.S. Senator Johnny Isakson (R-GA)
Hearing on Ensuring Drug Safety
Health, Education, Labor, and Pensions Committee

Sen. Johnny Isakson (R-GA): Thank you, Mr. Chairman. I apologize that I am late and did not hear your testimony and might be redundant in my questions. So be very brief or tell me I'm redundant and look it up in the book.

I think, following up on the previous questions, just your opinion on this external review, just real quickly, what is your take on that or the need for it?

Dr. Janet Woodcock: I think, of course, the FDA is open to various approaches and suggestions. But people need to have the correct -- say, in medicine, you have to have the correct diagnosis before you move into treatment. And I think people really need to think about what problem are they trying to address before thinking about what treatment to apply.

As I was just saying, the post-approval phase for a drug is a very active one where more clinical trials are going on. The label is being changed. The drug is being studied in additional populations. So the involvement of the medical team in the drug is also -- continues throughout that time.

And generally these are sub-specialists. We have neurosurgeons, neurologists, gastroenterologists and so forth all across the medical sub-specialties. And they have very deep and profound knowledge of their particular area and the use of therapeutics in that area.

And so, it would be difficult to imagine moving that process to some other unit. But perhaps people mean something else by what they're saying with the independent safety board.

Sen. Isakson: So within FDA following the approval of a drug, there is an ongoing tracking of the effects of that -- or any effects that are reported by physicians prescribing that drug? And that comes to FDA?

Dr. Woodcock: Yes, that part comes to the office of drug safety. But all the clinical trials and oversight of those clinical trials and the safety of the subjects and how the trials are designed and so forth, those are done by the medical division.

Sen. Isakson: How does that come back to FDA, that information? On paper and pencil or...

Dr. Woodcock: It's normally electronic. And these additional studies have to be done under an IND because they're human -- human subjects are being exposed in experimental conditions. So the FDA has a great deal of interaction and oversight into those ongoing trials.

Sen. Isakson: Are you one that subscribes to a belief that I'm coming to believe? And that is one of the greatest things we could do in health care overall is get technology involved so this information flows seamlessly and accurately from physician and pharmacist and patient and there's an integration of that information so it could be pulled down quickly?

Dr. Woodcock: You are reflecting my testimony. I totally agree with that. And we've been working very hard at the FDA to do our part to make that happen.

Sen. Isakson: Are you familiar with a company by the name of Greenway (ph)?

Dr. Woodcock: No.

Sen. Isakson: OK. After the hearing, I'll give you a note. There's some development on that end that's now actually out in practice in our home state, my home state of Georgia that is showing great promise in terms of information technology, patient, doctor, pharmacist.

Last, I just have a comment. You all take a lot of knocks lately. And there's been a lot of criticism. I'd like to just tell a story for the sake of the chairman and the committee.

On the 12th of September in 2001, a pharmaceutical company in my district contacted me, Solvay. They had a burn treatment known as foramazine (ph), which was in its final -- I don't know if I'm using the right word, but I remember they kept using the word protocol -- before issuance. You had said it had run out of the only other approved ointment of its type.

And obviously we had a serious, tragic -- I just wanted everybody to know that FDA's response that day and the ability to get those badly needed medicines to New York City in a time of great crisis was nothing short of unbelievable, which I don't portends that you only do timely work in an emergency, I might add, but you do good work all the time. And I appreciate what you do.

And that's all my questions or comments, Mr. Chairman.


Sen. Isakson: Thank you, Mr. Chairman.

Following up on that question, Dr. Psaty, I take it you disagree with that?

Dr. Bruce Psaty: No, actually I haven't advocated necessarily that the independent office be outside the FDA. I think in many instances the FDA has done terrific work. I would question some of the decisions they've made. But the office of new drugs currently dominates the CEDR, the drug review section. And the current structure at the FDA is just what the industry desires, a powerful engine to approve drugs and a weak effort to investigate safety in the post-marketing setting.

What the American public needs and deserves in addition to the rapid approval of drugs is a center whose mission is devoted to post- marketing safety evaluations.

Sen. Isakson: So your reference to independence was independence of the original testing not independence of the agency?

Dr. Psaty: Yes, it was. And I said in my testimony an independent center within the FDA.

Sen. Isakson: I just wanted to make sure I understood that. Thank you.

Dr. Psaty: Yes, sir.

Sen. Isakson: Dr. Wilson, is the insert that you have difficulty reading the same one I'm supposed to read in my medicine bottle?

Dr. Cecil B. Wilson: Senator, I would assume that it is very similar. As a matter of fact, in that regard, I frequently will move from the part I'm supposed to read to the part the patient's supposed to read. And I find them equally unclear.

Sen. Isakson: The only thing harder to read than the insert in a medicine bottle is the doctor's signature on a prescription.

Dr. Wilson: And the better the doctor, the worse the writing is.

Sen. Isakson: And I would acknowledge that I'm sure legal liability plays a large role in what has to go in that information. And I understand that, having been a businessman for 33 years. And I don't like for the government to get into business and start to say how big the letters ought to be and how short the words ought to be and things like that.

But I would say that from a standpoint of a patient, that information in regards to warnings to a patient certainly is what we ought to think about, given what we're talking about today. And that information a doctor needs with regard to what they need to know vis- a-vis warnings a patient might get -- if it was a little larger or at least at the beginning of that insert, it would sure be a help to me. And I take it it'd be a help to you. I don't know if that's AMA's recommendation, but that was just an independent advertisement.

Dr. Woosley, I read -- and I'm not sure I heard you say it. But I read in one of your recommendations that the user fee system should be replaced with a system in which industry support is not directly linked to the FDA's work and performance. Would you elaborate on that for a second?

Dr. Raymond Woosley: I applaud the willingness of the pharmaceutical industry to help the agency do its job in reviewing drugs. But when you tie it like piecework to the review of the drug, it really misses the real need that the agency has for something more than just reviewing that product.

When a new drug goes on the market, there are drug interactions with other drugs that can affect the safety and the use of other drugs. That isn't paid for when you just pay for the review. So by having more drugs on the market, you create more work for everybody and more surveillance.

So what I would suggest is that we come up with a way to fund the agency ideally without user fees. In a perfect world, that would be the goal. But that may not be the reality. So a compromise would be to find a way that the industry can support the FDA's role in assisting them in the regulation of their products.

Now that doesn't mean just reviewing the NDA. It means all of the work for the FDA that the FDA needs to do to improve the drug development process, to improve the drug surveillance system. How that's done, I mean, that's what you gentlemen and ladies are expert at. But I think the basic principle of tying it like piecework to the product creates the wrong environment.

It also -- because of the large amount of money coming into the FDA for that part of it and the lack of additional money for the rest of the mission -- I made the analogy to if you open up a restaurant and you sold all sorts of sandwiches but everybody bought the roast beef, then you become a roast beef store. And that's what the FDA has become because there's so much money now going for the review process and not for the rest of its work.

People think that it's beholding to the industry. It's not beholding to the industry. It's just that that part of it's well- funded. The rest of its mission needs to be funded also.

Sen. Isakson: My time's almost out, but I want to make sure I understood. You talked about a staged approval process. Did that mean that there would be a stage at which certain patients might get a drug before total approval took place? That's what that meant?

Dr. Woosley: That's what it means. It means that the drugs would be used in people who have been tested, that it would move into the community in a staged fashion. And as you learn more about it, then it would be expanded into the broader population.

Sen. Isakson: Just a comment, Mr. Chairman. I think her name is Mrs. Washington -- isn't it, that testified yesterday or the day before on behalf of cancer patients. That's a particular census of patients where it appears to me that would be a process well worth looking at. Is that the kind of thing you're talking about?

Dr. Woosley: Exactly.

Sen. Isakson: OK. Thank you, Doctor.

Thank you, Mr. Chairman.