New FDA Cheif Inherits Old Problems

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• RAY SUAREZ:

  The FDA has been an agency under fire in recent months for its role in overseeing drug safety. This week, there was new scrutiny when President Bush nominated the FDA's acting director, Andrew von Eschenbach, to become the agency's permanent chief.

  Von Eschenbach is also director of the National Cancer Institute and has said he will resign that post. But, in the Senate, von Eschenbach, the third commissioner appointed to the position by President Bush, faces a tough confirmation fight.

• WOMAN:

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• RAY SUAREZ:

  Front and center in the debate: the FDA's handling of emergency contraceptives, morning-after pills, known as Plan B. Some Democrats are pushing to allow what's now a prescription drug to be sold over the counter.

  On Wednesday, Senators Hillary Rodham Clinton of New York and Patty Murray of Washington announced they would put a hold on the nomination until the FDA makes a decision on Plan B's status. So far, the FDA has put off granting approval for Plan B, saying more research needs to be conducted.

  If confirmed, von Eschenbach will take over an agency heavily criticized by patients and scientists for insufficient drug oversight. The most prominent case recently involved the painkiller Vioxx, pulled from the market by Merck in 2004, after studies linked it to an increase of heart attacks and strokes.

  Some patients and doctors said the FDA did not adequately monitor the drug's problems. The FDA is known mostly for drug oversight, but the agency also regulates the safety of medical equipment, food, cosmetics, animal feed and other products.

  FDA-regulated products account for about 25 cents of every consumer dollar spent in the U.S.

  For more on the state of the FDA and the challenges facing its next leader, I'm joined by two people who have worked with the agency.

  Dr. Alastair Wood is associate dean at Vanderbilt University's Medical School and chairman of the FDA's Advisory Committee on Over the Counter Drugs. And Peter Pitts is director of the Center for Medicines in the Public Interest, a group that receives funding from the pharmaceutical industry. He had served as the associate commissioner for external affairs at the FDA.

  And, Peter Pitts, Dr. von Eschenbach has been acting commissioner since last fall. He replaced a man who had only served a few months, after his Senate confirmation, in the job. Is it important that an acting person be made permanent, that this agency have a leader?

• PETER PITTS:

  Oh, it absolutely is.

  An acting commissioner is a caretaker. And a confirmed commissioner can really energize the agency with an agenda and get things going. And that is important in an agency that is really devoted to advancing the public health.

  We simply don't have the opportunity or the — or the time to let the FDA do things slowly and waiting for someone to take over. Now is the time for somebody that can really get the job done in a very aggressive and appropriate way.

• RAY SUAREZ:

  Dr. Wood, do you agree with that?

• DR. ALASTAIR WOOD:

  Yes. I think it's more than that.

  A — a new leader can not only energize an agency, but can restore morale and bring people in to do new things, and — and provide really important new directions for an agency, which an acting director can't do. So, I think it's very important that we get a — a new agency commissioner.

• RAY SUAREZ:

  Well, Dr. Wood, what exactly does the FDA need? You have had in the recent past the approval of a cardiac defibrillator that had some problems, the much publicized Vioxx incident.

  What exactly is the FDA looking for from its next leader?

• DR. ALASTAIR WOOD:

  Well, I think the — the real crisis in drugs right now is that we need new drugs, and that there has been a — a fairly dramatic fall in the number of new drugs submitted to the agency. It's becoming harder and harder to develop new drugs.

  And we need to get incentives in place that encourage the development of drugs that we need. We need drugs to prevent diseases that my generation are going to get as we age, Alzheimer's, osteoarthritis, things like that. These are things that we don't have a system for right now. And we need to get one that encourages the development of these kind of preventive agents.

• RAY SUAREZ:

  Peter Pitts, is that the problem, a pipeline that is not full enough?

• PETER PITTS:

  I think that is certainly part of problem. And that's indicative of a bigger problem, which is that the FDA doesn't really have the tools to properly regulate and to put through the process 21st century personalized medicine drugs.

  And that is why the whole concept of the Critical Path project, which the FDA announced yesterday, to work with industry and academia to develop the new — new tools to regulate the new drugs of the 21st century, is so important. And that's why it was so surprising that it got such little media coverage today.

  A confirmed commissioner that is really empowered to move this agenda forward can use the bully pulpit to explain to people what this is all about, get it funded, and then get it done.

• RAY SUAREZ:

  But, Dr. von Eschenbach has been in charge, Mr. Pitts, since September. How come none of these things could go on while he was acting head of the agency?

• PETER PITTS:

  Well, things have happened since he was acting. Critical Path, for example, got a $6 million budget infusion, which is a — a down payment on America's future.

  Some new drugs were approved. Some very significant regulatory actions were taken. That's not to say nothing has happened. What I'm saying — and I think what Dr. Wood is saying as well — is that, with a confirmed commissioner, you can engender the career shaft to move forward, to take tough decisions, to get — get things done.

  Things are getting done now. Things need to get done, but more quickly and with — and with more precision.

• RAY SUAREZ:

  Is the FDA really being pulled in two different directions, Dr. Wood, on one side, being encouraged to speed up the approval process for certain much desired drugs, while, at the same time, being asked and cautioned to go slow, so that bad drugs don't hit the marketplace?

• DR. ALASTAIR WOOD:

  Well, you know, that's often the — the somewhat simplistic way that this is presented.

  But you know, the way I see it is, drugs are not like fine wines. Drug don't get better because the — because they are kept longer. And they certainly don't get better or safer just because they sit on somebody's desk for longer.

  So, the issue is not delaying approval. The issue is making sure we have the right data, we have the right information, and we have the right drugs, and to get them approved. Our crisis is in getting new drugs. And that's what we need to incentivize. By and large, drugs are remarkably safe.

  It's easy to forget that, given all the — the — the politics around this issue. But, by and large, drugs are — are pretty safe. We need drugs to treat the diseases that — that people are faced with.

  The second point I would make is, I — I don't think people fully understand how drug use has changed over the last few years. When I graduated from medical school, we largely treated episodes of disease that were fairly short and fairly defined. Now, thank God, we have been successful in preventing disease with drugs.

  And that means that we're treating people for a lifetime, and a lifetime that's longer because of these drugs. But it changes the risk-benefit thinking, because I always know the person who had an adverse event from a drug that is being given to prevent disease. I can never identify the person who benefited from that drug. And that's something we need to educate the public and politicians about.

• RAY SUAREZ:

  We got a brief description of a new system for approving drugs.

  Well, Peter Pitts, do you approve of that?

• PETER PITTS:

  Well, I think there is a lot to that.

  You know, the paradigm is changing, from one where we are — we are treating acute care, to one where we have — we are going to increasingly be dealing with chronic issues. And that is going to save a lot of lives, make people more productive. And, more importantly, it's going to save our health care system trillions of dollars. And, again, that is why leadership is so important. And the longer you put that off, the longer you put off moving in this direction.

• RAY SUAREZ:

  And, Mr. Pitts, the — all — the nomination of Dr. von Eschenbach to become permanent head already has two announced holds on it. Do you expect that this is going to be a — a rough couple of weeks?

• PETER PITTS:

  A rough couple of weeks, absolutely. But I think, if people are concerned about Plan B, than plan A should be a confirmation of an FDA commissioner.

• RAY SUAREZ:

  Well, the two senators in question, Senator Clinton and Senator Murray, thought that they had had just that arrangement with the previous confirmed head, Dr. Lester Crawford. But that didn't happen.

• PETER PITTS:

  Well, I don't think that you can use a drug approval or a drug action as a barter chip when you approve an FDA commissioner. That — that's not fair. And it's not appropriate.

  And what they really should be thinking about is what is best for the public health, you know, for the entire nation, rather than playing politics with an individual decision. I think asking a commissioner or a secretary or a president to set a precedent, wherein you can bargain with drug approvals, is just the wrong thing to do.

• RAY SUAREZ:

  But you are not saying that Dr. von Eschenbach has the luxury of going slow on Plan B, one way or the other, do you?

• PETER PITTS:

  Well, I think Dr. von Eschenbach has the responsibility to do the right thing, which is, look at the science and make a decision.

• RAY SUAREZ:

  And, Dr. Wood, what do you make — you were on the medical panel that approved Plan B for over-the-counter use. Where do you think that stands now, both in his likelihood of confirmation and as an issue facing the agency?

• DR. ALASTAIR WOOD:

  Well, I can't estimate his likely — likelihood of confirmation.

  But the — clearly, the right thing for any commissioner to do is make sure that he acts on the science. You know, the FDA is kind of like the referee in a — in a — in a match. You expect the referee to act on what goes on, on the — on the field, not on what goes on outside the — the field of play.

  Clearly, it's important that the FDA acts on the science that they're presented with, and acts appropriately on that. That is the only decision that's — that the FDA should be making. And if — if Dr. von Eschenbach wants to demonstrate his independence and his willing — his commitment to science, he will approve Plan B, rapidly.

• RAY SUAREZ:

  Well, Dr. Wood, we have been talking mostly about drugs, and, indeed, that is what the public largely associates the FDA with.

  But, as we mentioned earlier, they regulate a great many things. Is the agency funded, set up, staffed, to also regulate animal feed, medical devices, all the food that is sold in the United States, its transshipment and storage?

• DR. ALASTAIR WOOD:

  The FDA needs more funding. Now, that's probably a refrain that every agency will — will make, but the FDA clearly needs more funding.

  It needs more funding to — to conduct what has become a critical mission, as you say, in food, as well as in drugs and — and — and also in devices. It needs more funding to make sure that it's able to maintain — to — to retain the excellence staff that it has, and — and to enhance their morale, which is in a — a sorry state right now, in many cases.

• RAY SUAREZ:

  And, Peter Pitts, quickly, before we go, is the FDA asked to be, asked to do too much?

• PETER PITTS:

  It's not asked to do too much. It's asked to do too much with too little.

• DR. ALASTAIR WOOD:

  Right.

• PETER PITTS:

  You know, congressmen and senators and media and pundits want them to do more, but they are not ready to show FDA the money. And now is the time to do that.

• RAY SUAREZ:

  Gentlemen, thank you very much.

• DR. ALASTAIR WOOD:

  Thank you.

• PETER PITTS:

  Thank you.