THE WHITE HOUSE

Office of the Press Secretary

                     BRIEFING BY THE VICE PRESIDENT
           AND DR. DAVID KESSLER, FEDERAL DRUG ADMINISTRATION 

The Briefing Room

3:44 P.M. EST

VICE PRESIDENT GORE: I'm going to make a statement about some figures that were released by the CBO very late last night. I'm going to say a few words about the promises kept. And I'm going to turn this briefing over to Dr. David Kessler, who will elaborate on the announcement the President just made in the East Room and respond to your questions about that.

But first of all, let me talk just a bit about the new CBO figures released last night. When Bill Clinton campaigned for the presidency, he promised that he would cut the federal budget deficit in half during his first four years in office. He put that promised in writing in the book that he and I put out during the campaign, called Putting People First.

In fact, I think I might be able to find it right here. "Our plan will cut the deficit in half within four years and assure that it continues to fall each year after that," on page 4 of Putting People First. Yesterday, late last night, the Congressional Budget Office, using its traditionally conservative estimates, released brand new figures projecting that the budget deficit at the end of the current fiscal year will be half -- actually less than half -- of the deficit that President Clinton and I inherited. Bill Clinton made good on his promise.

When Bill Clinton campaigned for the presidency, he also promised eight million new jobs would be created in America by the end of his first four years in office. Earlier this month, the Bureau of Labor Statistics reported that we have crossed the eight-million job threshold. Since Bill Clinton became President, the American economy has added more than 8.4 million new jobs. Bill Clinton made good on his promise. And incidentally, more than half of these new jobs have wages higher than the average wage in the economy.

If you will look at this, from the day that President Clinton took office, the economy has created 8.4 million new jobs. And from the day he took office, the deficit has come down from $290 billion to the new figure of $140 billion at the end of this fiscal year.

Paul Volker, former chairman of the Federal Reserve Board, was recently quoted as saying, "The deficit has come down and I give the Clinton administration and President Clinton himself a lot of credit for that, and I think we're seeing some benefits."

The Congressional Budget Office in 1994, in its Economic and Budget Outlook, on page 13, said, the dramatic improvement in the deficit since last January is largely the result of the enactment in August of the Omnibus Budget Reconciliation Act of 1993. You may remember that measure passed a one-vote margin in the House, went to the Senate where it was tied 50 to 50, causing momentary despair -- (laughter) -- and then due to a provision in the Constitution I was able to vote. In any event we're very happy with these new figures, because the deficit has indeed been cut in half, and it will, as promised, continue to go down in the years ahead, because we're on the way to a balanced budget.

Incidentally, on this same page, I was noticing as I went through this material that just above the promise that I cited on cutting the deficit in half, was the promise that we would revolutionize government by cutting 100,000 federal jobs. As you may know, we have eliminated 205,000 federal jobs. Seven of the 14 Cabinet departments have had personnel reductions of more than 10 percent. Every single Cabinet department has had dramatic reductions except for the Justice Department, because there we are adding more personnel as part of the anti-crime bill.

Also, on the very same page, is the pledge to provide affordable quality health care by, among other things, reducing paperwork. And we talked about reinventing government in this same list of promises to the American people four years ago. And in the event in the East Room just concluded, the President announced the result of the National Performance Review effort at FDA, run by the people at FDA and run by Dr. David Kessler, which is resulting in much speedier approval of new drugs, new medications, new life-saving treatments -- in this case for cancer patients, but for all patients really.

And you have seen the difference for AIDS patients and for cancer patients particularly. And the announcement was one that was particularly moving for anyone who is part of a family that has been touched by cancer. And, again, as the President did earlier, I want to express gratitude to Dr. David Kessler and Secretary Donna Shalala, who was here earlier, and their whole team for the tremendous work that they have done.

And now I would like to turn over the podium to Dr. Kessler, who will elaborate on that announcement.

DR. KESSLER: Thank you, Mr. Vice President. And thank you for your leadership on the National Performance Review.

The four initiatives that the President announced today have a single significant meaning. American cancer patients from now on will have faster and easier access to more promising therapies. Here in a nutshell is the importance of each of the President's and the FDA's four proposals.

First, for patients with refractory, hard-to-treat cancer, instead of requiring evidence of clinical benefits, such as survival, FDA will rely on objective evidence of partial response, such as tumor shrinkage, as an initial basis for approval. This will allow us to rely on smaller, shorter studies for the initial approval of cancer drugs.

This accelerated procedure, which will be followed up by further studies on clinical safety and effectiveness in larger groups of patients, should and will simplify and speed up the evaluation and approval of drugs for advanced stages of solid tumors. Use of similar approaches to drug evaluation and review in our experience with AIDS therapies has been a powerful stimulus to the development of new and important agents, especially for people who need them most.

The second proposal, we will expedite the availability of promising medications that have been approved in certain other countries. If there is a promising drug approved in a foreign market, we will invite the manufacturer to submit to us the same information that made possible the approval abroad and whenever possible use it as a basis for making such therapy available under our expanded access programs to critically ill patients in this country.

Third, we will include representatives of cancer patients in FDA's cancer advisory committees and thereby make sure that their views are heard when it comes to recommending approval or nonapproval of cancer drugs.

And, fourth, we will eliminate unnecessary paperwork that used to delay or discourage cancer research by noncommercial, clinical investigators.

Two important points about these initiatives are of importance. First, they are designed to accomplish their aims without lowering FDA's high standards of drug safety and effectiveness, or reducing the amount of information available to patients and physicians. And second, they are not to be seen as one-time measures, but rather as part of a continuing FDA and administration effort to improve the quality and availability of drugs for all people with serious and life-threatening diseases.

I'd be happy to take a few questions.

Q Dr. Kessler, will FDA's initiatives that you announced today expedite the current review of anti-neoplaston treatments?

DR. KESSLER: The FDA's initiatives will allow the agency to rely on smaller trials, fewer patients if there is evidence of partial response in clinical trials. I don't want to get into any particular agent, except let me point out that the information needs to be part of clinical trials. We will accept less information up front. We're going to require further study after approval because the science has matured.

But the important point is that information needs to be gathered through scientific means, through clinical trials. And I think that's very important, a very important point. You can't just use an agent here or there. You have to use it as part of a clinical trial so we can get information on whether the drug works.

Q Will patients who have taken other forms of cancer treatments, chemo or radiation treatments, be allowed to participate in trials for anti-neoplastons?

DR. KESSLER: The agency has many trials -- has approved trials for patients with anti-neoplastons.

Q What are anti-neoplastons, for the laymen here?

DR. KESSLER: Again, I don't want to focus on any one particular cancer compound --

Q I just want -- for the dialogue.

DR. KESSLER: They relate to certain compounds that are being used and being promoted by a physician in Texas.

Q Is this going to change -- is this initiative going to change your staffing or the way you're doing cancer review?

DR. KESSLER: We have speeded up the process. Already, under the Prescription Drug User Fee Act, we have been able to add new medical reviewers to review of important new drugs by having the pharmaceutical industry pay user fees. That will continue.

This announcement today -- a significant portion of this announcement today, the President's announcement, is based on the science. We now know that partial responsers, evidence of tumor shrinkage, correlate scientifically with actual clinical benefit. So we're going to be able to rely on less data up front and more data after the drug is approved. We are taking some risks. We have to go into this with our eyes wide open. One day we're going to make a mistake, but I believe that's okay, especially when we're dealing with diseases for which there are not available therapies.

Q The President mentioned 100 drugs that would be expedited under this measure. Do you -- can you comment on any of those drugs?

DR. KESSLER: There are about 300 drugs under development. This framework, this regulatory framework that the President announced, would apply to all cancer drugs. Now, some may not in the end work, the evidence may not be there, the data may not support safety and effectiveness. But the regulatory framework certainly will apply, certainly to those drugs for solid tumors.

Q A question about timing. How soon is a someone who has cancer today likely to have access to a drug that they can't get now? How fast --

DR. KESSLER: We will be reviewing drugs immediately under the new regulatory framework. And I believe that you will see new agents emerge under the regulatory framework in months.

Q Dr. Kessler, to what degree did politics figure in this new initiative?

DR. KESSLER: None. The science really dictated this initiative. We now have the scientific evidence that demonstrates that we, in fact, can approve drugs on the basis of partial responses, and that's a responsible, scientific thing to do. That's real reform that, in the end, I believe will help patients.

Q Dr. Kessler, of the 300 drugs that are in various stages of development -- and some are probably further ahead than others -- are there any that are close enough that the regulations will have immediate impact on, and if so, what kinds of cancers do they treat?

DR. KESSLER: I think there are a number of drugs, a number of classes of drugs that this will apply to. Again, I'm restricted to those drugs for which the companies have already talked publicly -- but, Taxotere, Topotecan, CPT-11 -- those drugs, for a variety of solid tumors, could be candidates under this accelerated approval.

Q Could you talk a little bit more about the expansion of drugs approved abroad, and how long that process would take?

DR. KESSLER: If there is a drug anywhere in any country that there is reason to believe works against cancer, we believe at the FDA patients in this country should have access to those drugs. Now, we still need the data to determine whether those drugs work, but that doesn't mean we can't provide access on the one hand, and still get the information on the other hand.

We will approach the regulatory bodies in other countries and survey them if there are drugs approved in those countries that are not available here, we will approach the manufacturer and ask the manufacturer to give us the same information they supplied to the countries abroad and see whether we can make the drug available under expanded access, so patients can have access to it. At the same time, we're getting the data to determine ultimately whether the drug works.

Q Does this start immediately, as soon as you hear about the -- as soon as you can get access to the information, or would you have to review it first?

DR. KESSLER: We certainly need a short period of time to review the data. But we are committed to providing expanded access, availability to American patients for any drug that there's reason to believe may work. Patients should have access to drugs that may work, but we also have an obligation to get the information that demonstrates whether they really are effective.

Stacey Oller, for those of you who saw her in the East Room, the one thing that she said that I think resonated certainly very strongly is that one of the reasons that she is standing there today at 23 is because she had available to her medicines that worked. She had a form of kidney cancer, and the agents, only a few years earlier, had become available to treat that disease.

So, in the end, we want to provide access, but we also want to provide drugs that work. We are accelerating the approval of drugs. We're willing to let drugs out for cancer, for severe and all serious diseases on the basis of less information. But it's conditional, and it's conditioned upon getting further information. And the reason we can do that, and the reason we can do that responsibly is because the science has matured and allowed us to identify certain preliminary indicators, such as tumor shrinkage, that really do correlate with whether you're going to be helped by these agents.

Can I take one or two more questions?

Q Is the senior management of the FDA all on board on this? Is it fairly unanimous?

DR. KESSLER: This was designed by the senior management of the FDA.

Q No dissent?

DR. KESSLER: No dissent.

Q I remember in the early part of the administration, particularly in the health care debate, there was a lot of criticism of the drug industry as being excessively concerned with profits and insufficiently public spirited in their approach. In return for the flexibility that you're giving them, is there any reciprocity -- things that you're asking the drug companies to do in addition -- as a payback for the increased flexibility you're giving them?

DR. KESSLER: Develop drugs that will save lives. Focus on those diseases for which we don't have medicines. We're creating very clear guidance here. We did it in AIDS. We set out in 1992, under the accelerated approval regulations, very clear guidance. You could get a drug approved for AIDS based on certain preliminary indicators. You would have to do more studies afterwards. But if you look at the last four years, you see seven new drugs that followed that framework. And we want very much to create the same kind of incentive, the same kind of stimulus, for the development of all drugs, not only for AIDS and cancer but all serious and life-threatening diseases.

Thank you.

THE PRESS: Thank you.

END 4:04 P.M. EST