Mr. NELLIS. In closing, Mr. Chairman, I might say I have had some personal experience with the metropolitan area's task force on PCP and I want to commend you, lieutenant, and your colleagues, for the splendid work you have been doing.

Thank you, Mr. Chairman.

Mr. GILMAN. The gentleman from South Carolina, Mr. Mann.

Mr. MANN. I am sure that each of you would have your recommendation in your particular field as to what we can do to help on this problem. But I would like for each of you, if you will, to give us your quick opinion as to what we might do at the Federal level to help alleviate this problem from the standpoint of prevention, enforcement, treatment, et cetera.

Lieutenant Elkins, suppose you go first.

Lieutenant ELKINS. Thank you; like I said before, I think we should probably legislate some laws that would control the precursor chemicals that are used in the manufacture of PCP. That is one way we can probably eliminate some of the source material on the street.

Mr. MANN. Are those somewhat exotic chemicals?

Lieutenant ELKINS. No, they are generally used in other things, like plastics and things.

Mr. MANN. So it would be difficult to control them?

Lieutenant ELKINS. It would be very difficult to control, but it is something which probably ought to be looked into.

I think that the task force program in effect now in the metropolitan area, they should have that in other areas within DEA. It is a fantastic way to concentrate on a problem that is an immediate problem. They have been doing great work on that task force.

Mr. MANN. Why do you say Montgomery County is a PCP center? Lieutenant ELKINS. The only thing that I can tell you about that is we had a particular subject back in the late part of the 1960's or early part of the 1970's, who learned most of his technique from the west coast on producing these mind-expanding drugs. He started with LSD, got very proficient at making LSD. Then he passed on his information about LSD to several other people and pretty soon we were flooded with that.

Then he decided he would start to make PCP, so he did the same thing, he provided his friends with the necessary knowledge of how to produce it, and thereby they just kept going to their friends and more friends, like the commercial says, and pretty soon we had several labs in Montgomery County producing PCP.

Mr. MANN. Thank you very much. Doctor Luisada?

Dr. LUISADA. I think we certainly need more research into the treatment of PCP psychoses, and into the long-term effects of PCP on humans, and particularly what it does to their minds.

Mr. MANN. Do you see NIDA as the lead agency through which the Federal Government should promote that research? What agency of the Federal Government should be promoting that research?

Dr. LUISADA. I think either NIDA or the National Institute of Mental Health, depending upon their given mandates, would be quite acceptable in terms of how to do it. We certainly need more research

both into the immediate treatment of PCP intoxification, and the long-term treatment.

As you gentlemen also heard, programs such as Crossroads and other programs throughout the country usually given life as federally funded and that sort of program obviously is needed.

Mr. MANN. Thank you. Dr. Minyard?

Dr. MINYARD. I totally agree that more research should be done. Especially in the criminal justice area, and especially in traffic safety

areas.

Of course in trying to find out areas to adequately treat PCP psychoses and maybe trying to find a specific antidote for PCP victims.

So I definitely think research should be an extremely important area. I also believe and support Senator Bentsen's bill to increase the penalties for those people who are making PCP in the clandestine labs.

Mr. GILMAN. The gentleman's time has expired. Once again we want to thank the panelists for their contribution today.

The committee stands adjourned.

[Whereupon, at 4:30 p.m., the Select Committee adjourned, to reconvene subject to the call of the Chair.]

SUBMISSIONS FOR THE RECORD

Hon. LESTER L. WOLFF,

THE WHITE HOUSE, Washington, D.C., October 13, 1978.

Chairman, Select Commitee on Narcotics Abuse and Control,
U.S. House of Representatives, Washington, D.C.

DEAR CHAIRMAN WOLFF: As a follow-up to the "Federal Response to the PCP Problem" sent to you on September 7, and as a further follow-up to the August hearings on PCP, I am forwarding HEW's response to several specific questions which the Commitee raised after the hearings.

I would like to draw your attention to four particular points in HEW's response.

(1) Over the past year, NIDA, DEA and FDA have been coordinating an effort to identify, prepare and test analogues of PCP for scheduling. Two PCP precursors have already been placed in Schedule II and two analogues (PCE and PHP) have been controlled under Schedule I. Pharmacological testing of ten analogues is currently underway. Should there be any evidence that the action of these analogues is similar to the action of PCP, the analogues will be scheduled. (2) According to HEW's Office of General Counsel, veterinary use does constitute medical use.

(3) According to FDA's Bureau of Veterinary Medicine and the American Veterinary Medical Association, there is no effective alternative to PCP for the control of large primates.

(4) The only two legitimate manufacturers of PCP, Parke-Davis and PhilipsRoxanne, do not believe they can comply with the Schedule II requirements and hence have voluntarily asked FDA to withdraw their new animal drug applications (NADA's). In view of the lack of an approved NADA and consequently "no current medical use in treatment in the U.S.", FDA, DEA and NIDA are considering the appropriateness and feasibility of rescheduling PCP to Schedule I. You will also note in HEW's response that NIDA has prepared numerous fact sheets, reports and studies on PCP which have been forwarded to you. At the end of this week, we will be meeting with representatives from the Public Information Offices of NIDA, DEA and FDA to discuss ways of improving our distribu

tion system for information about PCP and evaluating the effectiveness of the information. We will also try to determine what additional PCP information is needed so that the public can remain current and informed.

In a separate matter, we have asked the appropriate agencies for their responses to the questions raised in Mr. Nellis' letter of September 26. The agency responses will be incorporated into a revised version of the Federal Response which is now being implemented. I will be happy to give the Committee a status report and evaluation of this effort in early November.

Thank you for your comments on the first draft of the Federal Response and I hope that these additional comments from HEW will be helpful to you. Sincerely yours,

Enclosure.

LEE I. DOGOLOFF,
Associate Director,
Domestic Policy Staff.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,

OFFICE OF THE SECRETARY, Washington, D.C., October 3, 1978.

MEMORANDUM

To: Lee Dogoloff.

From: Daniel J. Meltzer, Special Assistant to the Secretary.
Subject: Issues raised at August 8, 1978 Wolff committee hearings on PCP.

Your August 30, 1978 letter listed several requests for additional information concerning PCP that were made at the hearings on August 8, 1978 before the House Select Committee on Narcotics Abuse and Control. I have referred these requests to staff at NIDA and FDA and have reviewed their responses. I have also discussed them over the telephone with Phil Jordan at Justice, and we appear to be in agreement on substance.

The responses are as follows:

1. The advisability of controlling all precursors to PCP and its analogues The precursors of PCP (phenylcyclohexylamine and piperidinocyclohexane-carbonitrile (PCC)) have already been placed in Schedule II of the Controlled Substances Act. The analogues which have appeared as drugs of abuse on the street (PCE and PHP) have already been scheduled in Schedule I. We believe that all analogues that meet the CSA criteria should be scheduled.

During the past year, NIDA, DEA, and FDA have been coordinating an effort through the Interagency Committee on Drug Control to identify, prepare and test analogues of phencyclidine for purposes of scheduling. Under the scheduling provisions of the Controlled Substances Act, there must be some evidence of abuse potential in order to schedule a substance, and high abuse liability must be demonstrated to move it into Schedule I.

Ten analogues have already been synthesized and pharmacological testing is under way in several labs. We believe that evidence that the action of these analogues is similer to the action of PCP will suffice to schedule each of them. Moreover, if it can be demonstrated that several of these closely related chemicals possess PCP-like activity, we believe we would have a strong case for scheduling generically all chemically-related substances. However, it is not clear that this will prove to be the case. Moreover, if generic scheduing were to be considered, it would be necessary to examine and evaluate the impact of such scheduling on industry.

2. A legal opinion on whether veterinary use constitutes "medical use" under the Controlled Substances Act

As is indicated in the attached memo of September 20, 1978, prepared by Robert Dormer, Office of General Counsel, we have concluded that veterinary use does constitute medical use (Attachment 1).

3. A determination whether there are effective alternatives to PCP for veterinary

use

Attached are views from FDA's Bureau of Veterinary Medicine and the American Veterinary Medical Association (Attachments 2 and 3). The gist of these comments is that there is no effective alternative to PCP for the control of large primates. Furthermore, in informal discussions between practicing veterinarians and Department staff, the view that PCP was an indispensible aid in controlling large animals was also voiced most strongly.

4. A report on possible antidotes or blocking agents for PCP

NIDA has identified research needs in the area of PCP and PCP-like drugs in its announcement of funding priorities. One area of identified need is for research on antagonists.

At present there is no known antidotes to phencyclidine. Some thought has been given to the possibility of the use of cholinergic agents to block the effects of PCP, itself a central anticholinergic agent. However, these drugs often have side effects or cannot penetrate the central nervous system except in very large doses. To date, the efficacy of these potential blocking agents in antagonizing PCP's effects has not been studied systematically in animals or humans.

NIDA's division of research is currently funding studies in the use of more effective treatment. One such study is an evaluation of the most widely respected treatment regimen-which includes acidification of the urine and continuous gastric lavage, and has been reported to be an effective means of PCP detoxification. To develop more effective treatment, there is a need for information on the metabolism and disposition of PCP in the human body. NIDA will fund a study which investigates the relationship between dose, tissue, and fluid levels, and pharmacological and behavioral effects of PCP in humans. NIDA is also supporting a contract at Research Triangle Institute in North Carolina to develop methodological and clinical approaches to quantitative determination of PCP and other drugs in body fluids, using dosage forms and protocols approved by FDA.

5. A request that information (such as TV information, studies, reports, and press releases) be sent to interested Congressmen

On August 15, NIDA supplied the members of the House Select Committee on Narcotics Abuse and Control with all available materials on PCP. These materials include:

1. Phencyclidine: A Review. May 1978.

2. PCP Flyer: Spanish and English.

3. Letter to Program Directors-December 1 and December 6, 1977.

4. Letter to Medical Examiners and Coroners-December 9, 1977.

5. Phencyclidine Use Among Youths in Drug Abuse Treatment.

6. PCP: An Overview (NIDA Capsule).

7. Top 26 Problem Drugs in the U.S. (NIDA Capsule).

8. Announcement of Robert Blake: PCP Spot (Baretta).

NIDA plans to duplicate this mailing to all members of the House and Senate.

6. An update of PCP-Related activities

A summary document has been developed in response to a request from the House Select Committee on Narcotics Abuse and Control at the hearings on PCP held August 8, 1978. This document, as revised by HEW staff, describes all the current Federal efforts.

On August 11, 1978, Parke-Davis and Philips-Roxanne, holders of the new animal drug applications (NADA's) for PCP, voluntarily requested that the FDA withdraw the NADA's without prejudice. Both companies cited as reasons for their requests their inability to comply with Schedule II requirements. All existing stocks of PCP have been withdrawn from the market. NIDA has obtained roughly ten kilos, while DEA has destroyed roughly 40 kilos. FDA will shortly publish a notice in the Federal Register that the NADA's have been withdrawn.

FDA, DEA, and NIDA are considering the appropriateness and feasibility of rescheduling PCP to Schedule I when there is no approved NADA. Attachments.

Subject: Memorandum of August 30 from Lee Dogoloff to Dan Meltzer.

'In the subject memorandum Lee Dogoloff requests a legal opinion on whether veterinary use constitutes "medical use" under the Controlled Substances Act. I assume this question relates to the term "medical use" as it appears in the criteria

for scheduling under the CSA.1 No explicit answer to this question appears either in the CSA itself or the legislative history to the Act. It is clear, however, from a reasoned textual analysis of the CSA and applicable provisions of the Federal Food, Drug, and Cosmetic Act that the term "medical use" was intended to include veterinary use.

First of all, there is no indication anywhere in the CSA that approval of a drug for veterinary use was to be treated any differently than approval of a drug for human use. For example, the CSA provides for the registration of practitioners to prescribe Schedule II-V drugs [21 U.S.C. § 823 (f)]. The term "practitioner" is defined in part as "a physician, dentist or veterinarian . . who is licensed to dispense or administer controlled substances. [21 U.S.C. 802 (20) ]. Also, the CSA incorporates by reference the definition of "drug" contained in the Federal Food, Drug, and Cosmetic Act. [21 U.S.C. 802(12) ]. Under the FDCA the term "drug" is defined in part as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles

intended to affect the structure or any function of the body of man or other animals." [21 U.S.C. 321(g) (1)]. If veterinarians may be registered to prescribe drugs for the treatment of animals, it is reasonable to infer that veterinary use may logically be included within the term "medical use."

If veterinary use did not qualify as "medical use" under the CSA there would appear to be a serious conflict between the new animal drug licensing provisions of the FDCA and the CSA. A manufacturer could receive approval from FDA to manufacture a new animal drug and licensed veterinarians would concomitantly be able to prescribe or dispense the drug under the FDCA. However, if the drug were deemed to have no medical use in treatment in the United States and it met the other criteria for scheduling, it would be placed in Schedule I where its use would be limited to research purposes. This anomalous result should be avoided absent clear congressional intent that veterinary use was not to be considered medical use.

Lastly, a strong argument against construing the CSA to exclude veterinary use from the term medical use results from an examination of past agency practice. Neither of the agencies charged with administering the CSA has ever taken the position that veterinary use could not qualify as medical use. In the case of PCP, of course, this drug was scheduled in Schedule III and then moved to Schedule II. In both instances a currently accepted medical use is a criterion for scheduling. An administrative agency's contemporaneous interpretation of a statute it administers is entitled to considerable judicial deference. Power Reactor Co. v. Electricians, 367 U.S. 396, 408 (1961). Conversely, reversals of longstanding agency interpretations are frowned upon by the courts.

Accordingly, I think that a drug, which is legally marketed for a veterinary indication, has a medical use within the meaning of the CSA.

This analysis is fairly cursory but, I believe, sound. If you have further questions, please give me a call.

Attachment 2

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,

PUBLIC HEALTH SERVICE,
FOOD AND DRUG ADMINISTRATION,

September 18, 1978.

MEMORANDUM

To: Mr. Ansis Helmanis, Office of Legislative Services HFL-20. From: Director, Bureau of Veterinary Medicine HFV-1. Subject: Alternates to Sernylan to chemical restraint of subhuman primates. There is currently only one drug other than Sernylan approved for use in the restraint of primates. It is marketed under the tradenames of Vetalar and Ketaset and is known chemically as 2-(o-chlorophenyl)-2-methylamino cyclohexanone hydrochloride or simply as ketamine hydrochloride. Ketamine is an analog of phencyclidine hydrochloride with a shorter duration of action. This is

1 Schedule I drugs have "no currently accepted medical use in treatment in the United States." Schedule II drugs have "a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions." Schedules II-V drugs have a "currently accepted medical use in treatment in the United States." 21 U.S.C. 812(b).