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doctor and I greatly respect the medical profession. In fact, I was in it until I ran into organic chemistry in premed, so I became a lawyer. [Laughter.]
But that is why I think we have got to look at what the FDA protocol is and try and mesh with it, and then be as specific as we possibly can to make sure that we are not trying to eliminate legitimate research. But we are all going to have to work with the language. And I do appreciate your concerns. They are legitimate concerns.
Thank you, Mr. Chairman.
Mr. HUGHES. Dr. Tocus, I wonder if you will come forward for just a minute. Just pull up a chair. I just want to find a couple things out for my own information.
First of all, do you understand that there is a whole universe of researchers out there that are conducting research on analogs that are not required to file any application, either for a new drug application or an investigative application under 505?
Dr. Tocus. I am not aware there is, but there could be. I would not necessarily be aware if they haven't come to us.
Mr. HUGHES. Well, I think everybody can understand how there is a certain amount of research that goes on before an application is made to Food and Drug Administration.
Dr. Tocus. Yes.
Mr. HUGHES. Only common sense would dictate that. I just don't know how far along that process is before they finally come and make an application for a new drug application or an application for an investigative process.
Mr. Tocus. We felt that the proposed legislation covered that in the statement "intended for human use.” Anyone could synthesize any compound and do any studies they want and not violate it, as long as they don't intend to give it to humans.
Mr. HUGHES. How about if they intended to give it to themselves?
Dr. Tocus. I don't know that case. That is very interesting. We were just discussing whether that applied or didn't. I don't know that.
Mr. HUGHES. You mean in the back of the room?
Dr. Tocus. Yes. That hadn't occurred to us. In the type of research we are generally concerned with individuals don't give it to themselves. We don't feel that this is a controlled study, that it is a biased study. The person may expect to get an effect and, indeed, the expectation will cause it. So we don't usually include self-experimentation in the type of studies that we see at the FDA. However, I can understand that if someone wants to know what the effect may be, is it going to cause them to hallucinate, going to cause them to feel something, the investigator may take it one time to see what is going to happen to his patients.
Mr. HUGHES. That is logical, isn't it?
Dr. Tocus. Of course. I mean, I can understand that. However, that is not a part of the kind of research that we are talking about. We are usually concerned with unbiased controlled studies.
Mr. HUGHES. I think that I am pretty much persuaded by the argument that is made that if you are talking about psychoactive drugs in particular that the only way you are going to find out just what impact they have upon humans is to try it.
Dr. Tocus. Not quite. It is not quite that bad. We can tell whether a substance is an antianxiety agent. There are animal models that will categorize it into different pharmacological categories. We can tell analgesia. We can tell sedative effects. In the early stages of animals studies we can classify drugs into broad classifications. And I don't know that it is is necessary at the beginning of testing for someone to take it to find out what it does. I think all of those effects can be determined as the study progresses.
Mr. HUGHES. Well, is it your testimony that, and apparently you do concede, there are folks out there who have not applied to FDA that are conducting research on analogs?
Dr. Tocus. I don't doubt it.
Mr. HUGHES. And it would be your reading of the statute that if, in fact, they possess any of those analogs that would trigger a criminal violation.
Dr. Tocus. If they intend to give them to humans.
Mr. HUGHES. Which just means it is a jury question as to whether that is the case.
Dr. Tocus. I suppose, yes.
Mr. HUGHES. So a researcher that is conducting research who hasn't made an application to FDA really would be safe, or who hasn't reached that stage who might intend to take the analog himself to see what the psychoactive results are would trigger a violation.
Dr. Tocus. Yes, sir.
Mr. HUGHES. Well, thank you. I really appreciate your testimony. It really is a very interesting area, and I think we have spent the better part of the day talking about it. [Laughter.]
But it has been extremely productive, and I can say for this member that it has been very helpful. And we thank you for your assistance.
That concludes the testimony. The subcommittee stands adjourned.
[Whereupon, at 2:05 p.m., the subcommittee was adjourned.] [The following was submitted for the record:]
To require the National Drug Enforcement Policy Board to provide a comprehen
sive assessment of the designer drug problem and make recommendations to Congress for necessary legislation.
IN THE HOUSE OF REPRESENTATIVES
APRIL 4, 1985 Mr. RANGEL (for himself and Mr. GILMAN) introduced the following bill; which
was referred to the Committee on the Judiciary
A BILL To require the National Drug Enforcement Policy Board to
provide a comprehensive assessment of the designer drug problem and make recommendations to Congress for necessary legislation.
Be it enacted by the Senate and House of Representa
2 tives of the United States of America in Congress assembled,
3 That (a) the Congress finds that4
(1) the use of illegal narcotics is a major health,
law enforcement, and economic problem for the United
(2) the Congress has determined that the control
of illegal narcotics and drug abuse are national prior
(3) the Congress has identified “designer drugs” as new chemical analogs or variations of existing con
have a psychedelic, stimulant, or depressant effect and
(4) that synthetic narcotic analogs are linked to
(5) significant increases in the consumption of synthetic narcotic analogs would pose an imminent hazard
(6) the virtually unlimited modification potential of synthetic narcotic analogs undermines effective imple
mentation of the Controlled Substances Act;
(7) the National Narcotics Act of 1984 established
(8) the Board has among its responsibilities the development of United States policy with respect to illegal drug law enforcement; and
(9) the Chairman is required to report to the Con