Mr. LUNGREN. Pardon me?

Dr. Houk. There is not even an exemption for the Federal Government.

Mr. LUNGREN. Geez, that is one we missed along the way I guess. [Laughter.]

OK. Thank you very much. Thank you, Mr. Chairman.

Mr. HUGHES. Let me just follow up, if I might, just on that point once again dealing with what would be caught by existing law; who would have to, in fact, register. If I were a private researcher, a physician, working with a couple other physicians and I developed an analog that I want to test. I don't want to distribute or market in interstate commerce, but I want to test on some patients. What is required of me by Federal law presently?

Dr. Tocus. You must demonstrate that the substance that you want to test is chemically within certain limits in terms of purity. You must demonstrate, with results of animal toxicity studies, that the doses that you want to give to humans are reasonably safe by the route that you want to give them.

Mr. HUGHES. I have to establish that to the Food and Drug Administration?

Dr. Tocus. Yes. But you really should want to establish that to yourself. Because if you are a physician and you are going to expose your patients, you must certainly have some scientific data which demonstrates satisfactorily

Mr. HUGHES. Would I fall within one of these two exceptions?
Dr. Tocus. Pardon me?

Mr. HUGHES. Would I fall within one of these two exceptions: an exemption for investigational use within the meaning of section 505 of the Federal Food, Drug, and Cosmetic Act

Dr. Tocus. Yes, sir. If you submitted an IND application to the Food and Drug Administration, then you would be exempt.

Mr. HUGHES. Or a new drug application?

Dr. Tocus. Well, a new drug application is way down the line. That is after we have got all the studies completed.

Mr. HUGHES. But I would fall within the exemption, section 505? Dr. Tocus. Yes. If you submit an IND to the Food and Drug Administration.

Mr. HUGHES. And I would be required to?

Dr. Tocus. That is my understanding.

Mr. HUGHES. Before I could conduct that kind of research, I would be required to file an application with the Food and Drug Administration?

Dr. Tocus. That is my understanding.

Mr. HUGHES. There is a number of other areas that we have to get into, and that is another vote. So I hate to ask you to remain for a little bit, but I am going to recess for another 10 minutes. [Recess.]

Mr. HUGHES. The subcommittee will come to order.

I know, Dr. Houk, you have a plane to catch. We can just take your area, then perhaps excuse you, then I will get back to this other area.

I understand that the proposed rescission of that million dollars that your center has for its research in these analogs has been re

jected and that money will be spent for your center. Am I correct in that?

Dr. Houk. Yes, sir, you are, Mr. Chairman.

Mr. HUGHES. I see. Is that adequate resources given the dimension of the problem?

Dr. Houk. We have designed a program using that million dollars to initiate something and, if I may, I would like to describe what we know now and how we are going to go about using the million dollars this year to learn more.

In California we know that, as you said in your opening statement, there are hundreds of people involved-there are at least 10 who have definite Parkinson's disease or Parkinson-like things, and dozens more who have symptoms like that. We have 287 people who have been definitely exposed who are being followed in a longterm follow-up.

In Florida, there is at least one person who has known Parkinson's and several suspected cases. In South Florida it appears that the MPTP analog is present both by itself, as a contaminant of what is labeled as heroin, and as a contaminant of what is labeled as cocaine. Also based on the description of the kinds of drugs in use it appears that we have a similar problem in Detroit and also the State of Texas. And I think to say that the problem is limited to those areas does not meet with fact. We certainly think that it is beyond that.

What we intend to do in addition to following-up to learn more about this-and as Dr. Hawks says, the administration and HHS certainly support our efforts, to try to stop this and to deal with what is already out there, are the following kinds of actions. As Senator Chiles mentioned, one of the major things is going to be an educational program in the very low levels of the schools. And this is not going to be textbooks. We are trying to figure out ways now that we can use the video tapes that you have now if we can resolve the privacy issues. If the kids see the results of taking these drugs this is the best thing. We have experience in smoking and a few other things, that indicates more impact if they actually see the damages rather than being told about them or the elusive idea of death.

In addition, we are going to establish a surveillance system with the forensic pathologists in the country to assist them when they have deaths or overdoses of unknown kinds, to determine whether or not it was a "designer drug" rather than some unknown cause. We will set up a surveillance system with the neurologists in the large cities of the country specifically looking for young people with Parkinson-like disease.

In addition, where we have some reason to suspect potential problems we will try to set up some focus where people can send anonymously samples of their street drugs and the drugs that they have to be analyzed. And they can get that report back on an anonymous basis with a number, but in addition to that, it will give us a handle of where these "designer drugs" are located throughout the country and in these particular cities.

And last, but equally important, is to develop some standards for safety for the Drug Enforcement Administration inspectors who raid the clandestine laboratories and are involved with other ac

tivities that might result with dangerous contacts with these drugs. Because there is pretty good evidence that a very small amount of this entering the body inadvertently through the skin or just inadvertently taken in by someone who didn't intentionally do it can produce the same kinds of health problems which the drug abusers experience.

We put very high priority on trying to solve this problem, getting information out to the people in Florida and California, a large distribution to the medical community, but more importantly, to the drug-abusing community-the streets, the clinics-of what they can expect if they handle or their hands on some of these products. I would urge since we are going to be dealing a lot with youngsters that we try to get rid of the term "designer drugs." Designer refers to "Calvin Klein" jeans, designer shoes-generally good things, as does "recreational." We need some other term that has the connotation that it is a bad substance.

Mr. HUGHES. Do you have a suggestion?

Dr. Houk. I think "controlled substances analog" is a very good

one.

Mr. HUGHES. I see. It sounds like you have a number of initiatives underway to deal with the controlled substances analog problem. Have there been any research programs cancelled, any initiatives cancelled, for lack of resources?

Dr. Houx. We have been involved in this since 1983 using our own funds under other authorities, principally section 301(a) of the Public Health Service Act. We have not had sufficient moneys to do as much as we want to. There has been nothing cancelled. We would not use this money that is coming to us that Senator Chiles was instrumental in getting into the Senate appropriations for basic research on Parkinson's disease as it relates to this drug. We think that these moneys are for the purposes of trying to prevent the spread of these drugs among young people and to other people, and there should be other moneys to do the basic scientific medical research on Parkinson's.

Mr. HUGHES. Thank you, Doctor. We appreciate your testimony. And you are excused so that you can catch your plane. Thank you so much.

Let me, if I might, Dr. Hawks, just take you back to the central question of the breadth of the statute and whether or not it is going to catch unwittingly people who are conducting bona fide research. Any suggestions on how we can clarify it any more than we have in the proposed bills to make intent very clear?

Dr. HAWKS. Well, let us say we have discussed that point among ourselves as well as with some of our grantees and contractors who work in this area, and without getting into what I would consider fairly cumbersome descriptive language of the kinds of situations that they would be concerned about, I am not sure we can do a great deal better than what is in there now. At least I haven't heard suggestions and I haven't been able to come up with much better ones on my own.

It does say that we don't want to inhibit-in the bill-legitimate scientific research, and that is defined primarily by whether someone has an IND or an NDA application or whether they are using it for something other than human purposes.

One could think of words such as establishing credentials for people who might not yet have an IND and who have been doing research on certain kinds of compounds or for certain kinds of purposes, but you very quickly get into the kinds of things that people would bring up if they were taken to court to prove their innocence, or from the other side, to provide their lack of innocence. It almost seems like those kinds of subtleties are going to have to be worked out when this bill starts being used for enforcement and from interpretations from the courts and in the policy that results from that.

I don't have any immediate suggestions for changes in the wording.

I think Dr. Tocus has a comment to make on that, if he would. Mr. HUGHES. When an analog is being investigated pursuant to an investigative process, they still are required to apply for registry with the Food and Drug Administration?

Dr. HAWKS. If it is not intended for human use, there is no reason to. I mean, if there is not going to be human experimentation.

Mr. HUGHES. If it is not intended for human use.

Dr. Tocus. Mr. Chairman.

Mr. HUGHES. Is that the only exception?

Dr. Tocus. An application can be made to the Food and Drug Administration at any time along the development of the drug. They don't have to wait until they intend to give it to humans. Someone interested in developing a drug can make an application at the time they first synthesize it and carry that along.

It is our belief that the Food, Drug, and Cosmetic Act is the best and quickest way to see a drug that has useful therapeutic uses gets to the market. We see that studies have proper controls. One of the things that we look at is the design of the studies to make sure that there is useful scientific information that is going to come out, that people aren't put at risk with the drugs that have no basis in scientific fact.

Actually, the Food, Drug, and Cosmetic Act is the mechanism by which drugs can quickly come to market. One of the greatest rewards of working at the Food and Drug Administration is seeing a good drug get through and get out to the American people. That is what we want. If it has useful activity, we work with the scientists. But we make sure that it is on a scientific basis.

Mr. HUGHES. OK. I don't have any further questions.

The gentleman from California.

Mr. LUNGREN. No, I have no questions.

Mr. HUGHES. Well, thank you very much, Doctors. We appreciate your testimony. You have been very helpful to us today, and we appreciate that very much.

Mr. HUGHES. Our last witnesses will appear as a panel. Our panel consists of:

Mr. James N. Hall, the executive director of the Up Front Drug Information Center, Miami, FL, a member of the Florida cocaine task force set up by Governor Bob Graham and a member of NIDA's community epidemiology work group.

Robert T. Angarola, a lawyer with the firm of Hyman, Phelps & McNamara, a professional corporation, here in Washington. Mr.

Angarola served in the Office of General Counsel in the White House Special Action Office for Drug Abuse Prevention in 1972. In 1973 he became the legal adviser to the International Narcotics Control Board in Geneva, Switzerland. In 1977 he was asked to serve as general counsel of the White House Office of Drug Abuse Policy, and later served as the Assistant Director of the White House Domestic Policy Staff dealing with health and drug issues. Dr. Lester Grinspoon is associate professor of psychiatry at the Harvard Medical School in Cambridge, MA. As a distinguished physician and teacher for over 30 years, he has been a member or officer of numerous professional boards and associations. He has testified before numerous government, legislative and research panels. He is the author or co-author of over 100 academic papers, and the author, co-author or editor of some 14 books.

On behalf of the American Psychiatric Association is Dr. Everett Ellinwood, professor of psychiatry and Pharmacology at Duke University Medical Center. Among Dr. Ellinwood's many credits, he is a fellow of the American College of Neuropsychopharmacology and a member of the research council of the American Psychiatric Association.

Gentlemen, we welcome you here today on behalf of the committee. We have your statements, which will be made a part of the record without objection, and you may proceed as you see fit. We will begin with you, Mr. Hall. Welcome.

STATEMENTS OF JAMES N. HALL, DIRECTOR, UP FRONT DRUG INFORMATION CENTER, MIAMI, FL; ROBERT T. ANGAROLA, ESQUIRE, HYMAN, PHELPS & MCNAMARA, WASHINGTON, DC; LESTER GRINSPOON, M.D., ASSOCIATE PROFESSOR OF PSYCHIATRY, HARVARD MEDICAL SCHOOL, CAMBRIDGE, MA.; EVERETT H. ELLINWOOD, JR., M.D., PROFESSOR OF PSYCHIATRY AND PHARMACOLOGY, DUKE UNIVERSITY MEDICAL CENTER, ON BEHALF OF THE AMERICAN PSYCHIATRIC ASSOCIATION Mr. HALL. Mr. Chairman, and members of the committee, thank you for addressing one of this decade's more complex issues in the drug abuse field. The name "designer drugs," has caught the attention of the media over the past year and a half as a new trend in America's illicit drug scene. As you aware, the term does not refer to a particular pharmaceutical classification but rather to a method of making new products for the illicit market. Such drugs may carry few, if any, legal risks, yet offer greater profits than selling controlled substances.

The problem of clandestine, synthetic drugs is not a new topic. Up Front Drug Information Center in Florida has warned about dangerous drugs in the street market for the past 13 years. Our telephone hotline, recorded drug warning messages, laboratory analysis program and publications have exposed deadly deceptions associated with illicit drug sales.

We have witnessed fake, toxic street drugs before, bootleg Quaalude tablets, phoney cocaine, and fake heroin. Yet some of the designer drugs we discuss today have escalated the human risk of drug use to potentially catastrophic levels.