were still being actively investigated by DEA. The IRS could not find enough data on a rather large number to initiate immediate investigations. However, IRS is currently conducting approximately 250 investigations involving narcotics traffickers, including the 74 DEA selections mentioned above. Of major importance to DEA are investigative leads and criminal intelligence information from IRS. Resolution of past IRS disclosure problems is therefore essential, and has been the subject of continuing discussion involving staff officers of the two agencies; solutions have been found, and will soon be implemented. Also being discussed under the traffickers tax program is the application of IRS expertise to DEA cases of significance, involving the manipulation of millions of dollars using a variety of sophisticated techniques; plans call for the detailing of IRS agents to DEA conspiracy investigation (CENTAC) teams. One project that has already been initiated involves cross-training between the two agencies; IRS lecturers have thus far participated in three schools for DEA agents and analysts. DEA has expressed support for augmentation of the Internal Revenue Service budget and ceiling to permit that agency to increase its comitment to the narcotics traffickers tax program. The IRS National Office should be charged with overseeing proper utilization of the additional resources, which will be committed at the District Office level, and with ensuring that the IRS field be held accountable for responding to the increased national priority for the program. The DEA aim is to achieve maximal disruptive impact on the narcotics traffic, through enhanced casemaking in this joint area. DEA is also urging that civil as well as criminal tax action be pursued vigorously by IRS, toward depriving traffickers of illicit profits and neutralizing their operational funds. Mr. ROGERS. Do you plan to expand the DIU program? Mr. BENSINGER. Yes, sir. Mr. ROGERS. Would you outline your current activities and future plans for expansion of this program for the record? Mr. BENSINGER. I will indeed. [The following statement was received for the record:] The long-range goal is to install DIUs in approximately 40 States, at the rate of 3 to 4 per year. The scope of the registrant population in the remaining States is such that a high-impact program like this is not necessary. Mr. ROGERS. Does DEA have authority to make grants or enter into contracts? Mr. BENSINGER. We have in the bill proposed, the appropriation bill, for 1978 of $181 million some grant authority for State and local police jurisdictions because we will be assuming $6.7 million that LEAA previously had funded to State and local police. Mr. ROGERS. But authority for that program is not in the Controlled Substances Act? Mr. BENSINGER. No; it is not. Mr. ROGERS. Would you want to have specific authority for that purpose? Mr. BENSINGER. We would like that because we would need that authority particularly with respect to the DIU's. Mr. ROGERS. Have you taken any actions to prohibit manufacturers and distributors of drugs under schedules 2 through 4 from providing complimentary samples of such drugs and supplies to physicians? Mr. BENSINGER. We have talked in a regulatory task force committee with FDA and NIDA and the Postal Service and Federal fair trade agency on a number of items. One of them is labeling. One of them is samples, free samples for the medical profession. Another area that was gone over was the length of time by which drugs can be refilled and the number of refills that pharmacies can in fact function under. This is one of the items that has received our attention and has our concern. Mr. ROGERS. Let us know the specifics on that. Mr. BENSINGER. We will. [The following document was received for the record:] [From the Federal Register, vol. 42, No. 134, July 13, 1977] DEPARTMENT OF JUSTICE; DRUG ENFORCEMENT ADMINISTRATION COMPLIMENTARY SAMPLING OF CONTROLLED SUBSTANCES Statement of Policy and Withdrawal of Proposed Regulations Agency: Drug Enforcement Administration. Action: Withdrawal of proposed rule. Summary: This notice announces the present policy of the Drug Enforcement Administration to encourage drug manufacturers of controlled substances who promote such products through the distribution of samples to doctors by detailmen to substitute other, safer promotional methods designed to reduce diversion. As a result of the adoption of this policy, the Drug Enforcement Administration hereby withdraws its proposed rule (41 FR 32756, August 5, 1976) which would have absolutely prohibited drug manufacturers and distributors from providing complimentary samples of controlled substances in schedules II through V to their customers. For further information contact: Richard Ira Lebovitz, Attorney, Office of Chief Counsel, Drug Enforcement Administration, 1405 I Street NW., Washington, D.C. 20537 (202-382-3411). Supplementary information: On May 19, 1976, the American College of Neuropsychopharmacology (ACNP) petitioned the Administrator of the Drug Enforcement Administration to initiate proceedings for the amendment of 21 CFR 1301.74 (d). That section essentially permits non-practitioner registrants to distribute complimentary samples of controlled substances in schedules II through V, with certain restrictions. The ACNP petition is a proposal to amend 21 CFR 1301.74 (d) so that such registrants are absolutely prohibited from distributing controlled substances in schedules II through V as complimentary samples to their current or potential customers. On July 29, 1976, the Administrator of DEA issued a notice of proposed rulemaking in respect of the ACNP petition (41 FR 32756, August 5, 1976). In his attempt to determine whether the regulation proposed by the ACNP is necessary and appropriate, the Administrator in the Notice stated that DEA was reassessing its position on sampling and its efforts would be aided by receiving from all interested persons information concerning what the position of various State authorities is on sampling, how much of legitimate drugs are used for sampling, how samples are used by doctors, and, most importantly, how much sampling results in diversion. Six specific questions designed to guide responses to the proposal to provide such information were listed in the August 5, 1976, Notice. Seventy comments were received by DEA in response to the Notice, and they included submissions by drug manufacturers, present and former drug detailmen. State boards of pharmacy and other State licensing authorities, pharmaceutical associations, medical associations, and individual pharmacists. In addition, the comments of the National Institute on Drug Abuse were requested and received. DISCUSSION OF COMMENTS RECEIVED With three exceptions, all drug manufacturers commented that they were against a ban on sampling such as that proposed by the ACNP petition, listing among their reasons that sampling provides one method for testing the merit and usefulness of their products, and that sampling, as a long established procedure recognized and in fact currently permitted and regulated by DEA, should not be banned unless substantial evidence of diversion compels that result. In contrast, the majority of pharmacists, their professional associations and State boards of pharmacy commented in support of the ACNP petition to ban sampling, stating that the true clinical value of a drug cannot adequately be determined from the practice of doctors dispensing samples of drugs to their patients in lieu of writing a prescription. In support of this, they argued that industry knowledge of the clinical efficacy of a drug does and should continue to come from well-controlled studies in conformance with established testing protocol and reporting requirements regulated and monitored by the FDA. Further, they alleged, without providing a significant statistical or factual basis, that there is a potential for diversion inherent in drug sampling and that diversion and abuse occurs widespread. Finally, from these commenters there emerged the recommendation that if sampling were to continue, that it be in the form of complimentary prescriptions or some similar method designed to permit a patient to obtain the medication his doctor wants without cost and to eliminate the sample package as the method for providing that service. Many other thoughtful comments and observations were set forth in the responses submitted. However, those comments and observations, while generally enlightening, were determined by DEA to be neither essential nor material in assisting the agency in its tasks of resolving whether substantial evidence of diversion of controlled substances samples exists so as to require the Administrator to issue the regulation proposed by the ACNP petition. In resolving this issue, the Administrator takes special note that the ACNP petition itself states that "[p]etitioner maintains neither that diversion of samples of controlled substances is occurring in fact, nor that physicians receiving such samples are utilizing them for other than legitimate medical purposes." Rather, the petition urges a ban on controlled substances samples because it alleges there exists in them a potential for diversion from established distribution channels. Responsive to this basis for the petition is the viewpoint of the National Institute for Drug Abuse which was requested and received by DEA. After reviewing all the comments on sampling which DEA had received, Dr. Robert E. Willette, Chief, Research Technology Branch, Division of Research, provided the observations of NIDA which state: After reviewing the several responses for and against the subject Notice, I am led to agree with the position that the petition should be denied. It would appear that in order to support the prohibition that a substantial potential for diversion or evidence of diversion must exist. ACNP does not present such evidence. Much of the criticism addressed in favor of the petition was more directed at abuses in general of the sampling process, an area out of DEA's jurisdiction, rather than any specific problem with controlled drugs, in fact, both sides acknowledged that the present written request system and accountability of sample distribution for Schedule II drugs appears to offer adequate safeguards against diversion. If diversion of Schedule III-V drugs is evidenced, similar controls could be imposed. In addition, the Office of Compliance and Regulatory Affairs of the Drug Enforcement Administration has conducted a field survey in DEA's own attempt to refine the pattern of diversion of drug samples. The results of that survey show that there have been isolated instances of diversion of controlled substances samples, mostly involving detailmen, and that it is not widespread nor is it a major area of diversion. As a result of the DEA study, and of its review of the NIDA comment and all comments submitted in response to the proposal, and of other information available concerning the drug industry practice of sampling, the Administrator of the Drug Enforcement Administration hereby finds that: (1) There have been specific instances of diversion of samples of controlled substances; (2) Such instances are not widespread-they are limited and have been largely attributed to drug detailmen ; (3) There presently is not significant evidence of diversion of controlled substances samples; (4) Instances of diversion of such samples can be further reduced if drug manufacturers eliminate their present practice of having detailmen supply samples to doctors and instead themselves distribute the samples to the doctors directly, or provide doctors with complimentary prescriptions for such drugs rather than samples of them. DEA'S POLICY Therefore, the Administrator of the Drug Enforcement Administration concludes that significant diversion has not been demonstrated which would compel promulgation of the rule proposed by the ACNP petition to prohibit nonpractitioner registrants from distributing controlled substances in schedules II-V as complimentary samples. Accordingly, the Administrator, under the authority vested in him, declines to adopt, and hereby withdraws, the proposed § 1301.74 (d) of Title 21, Code of Federal Regulations, originally published in the FEDERAL REGISTER (41 FR 32756) on August 5, 1976. In furtherance of DEA's mission to prevent diversion of all controlled substances, the Administrator announces that it is the policy of DEA to encourage drug manufacturers not to distribute controlled substance samples through detailmen and to substitute other, safer methods of promoting their products. These methods could include sending samples to physicians directly and not through detailmen, and to institute complimentary prescriptions. If DEA determines in the future that the pattern of diversion of controlled substances samples, by detailmen or otherwise, requires further regulation than that presently required, it will at that time take appropriate action. Dated: July 7, 1977. PETER B. BENSINGER, Administrator, Drug Enforcement Administration. Mr. ROGERS. Why do we need a 2-to-1 ratio of the total DEA employees to put 2,000 law employment agents in the field? Can you improve that ratio? 4,000 employees and only about 2,000 agents in the field? Mr. BENSINGER. No, sir, because the number of compliance investigators, for example, the 2,000 agents are 1,811 criminal investigators. We also have some 300 individuals directly involved in the compliance and regulatory program. Mr. ROGERS. Out of the 4,000? Mr. BENSINGER. Yes, sir. We also have, I believe-and the Director of Science and Technology can correct me-somewhere between 150 and 160 chemists. Mr. ROGERS. I think you should specifically outline the various categories of DEA employees for the record. Mr. BENSINGER. We will give you a breakdown of our personnel. [The following information was received for the record:] DEA's on-board personnel as of May 31, 1977: Mr. BENSINGER. But it isn't just agents who are going to make our case. We need intelligence analysts who are not criminal investigators. Mr. ROGERS. Let us know your needs for more intelligence analysts for the record. [The following information was received for the record:] INTELLIGENCE ANALYSTS Intelligence analysts are needed in DEA to meet the ever increasing demand for support of the agency's domestic enforcement operations as well as support for foreign government narcotics control programs, through providing operational, tactical and strategic analyses. Operationally, the analyst provides for the strengthening and/or expansion of DEA investigations through the research and analysis of existing information. This function is of vital importance to both enforcement and prosecutors in light of DEA's concentration on the immobilization of major traffickers/organizations through the development of conspiracy investigations. Tactically, analytical support must be rendered to field elements on a day-today, if not hour-to-hour, basis in support of ongoing investigations, as is the case with DEA's El Paso Intelligence Center. Additional analysts are required, particularly at EPIC, to support increasing roles played by the center in aiding field investigative and interdiction efforts. This interagency center services not only DEA, but its participating agencies, such as Customs, INS, FAA, Coast Guard and ATF, as well as State and local enforcement agencies. Strategically, analysts play a vital role within DEA in measuring impact of enforcement efforts on drug trafficking, determining availability of illegal drug supplies, and identifying significant trends ånd patterns. Their studies support managers in their planning, targeting and more effective use of DEA's resources. Along with our need for additional analytical capability to support DEA enforcement efforts, there is a high priority for drug intelligence exchange with other agencies, both Federal and state and local, for a more effective narcotics control program. Mr. ROGERS. How about labs? Does DEA have sufficient labs? Mr. ROGERS. Do you do your own work now? Mr. BENSINGER. Yes; we do. We are satisfied with our labs. They do an excellent job. Mr. ROGERS. Do you ever have to use anyone else's labs? Mr. BENSINGER. No, sir. We in fact provide information to State and local police departments when they submit samples to us. Mr. ROGERS. You have reduced the manufacturing quotas for amphetamines. Are you going to reduce the quotas for barbiturates? Mr. BENSINGER. I think we will be looking at barbiturates. Mr. ROGERS. Would you detail for us how that should be done? And what degree of reduction you think is sufficient? Mr. BENSINGER. We will be pleased to do that. Mr. ROGERS. Do you work with FDA on manufacturing quotas for amphetamines and barbiturates? Mr. BENSINGER. We work with FDA on that. We have had meetings with the Office on Drug Abuse Policy on barbiturates. There are going to be hearings this May on amphetamines. We believe there will be public hearings on barbiturates. There are three principal fast-acting ones that have the concern of the Office on Drug Abuse Policy. We will detail that in our response. Mr. ROGERS. I think that would be helpful to have for the record. [The following statement was received for the record:] On May 12, 1977, Mr. Bensinger, along with Dr. Bourne, ODAP, and representatives of NIDA and FDA, met at ODAP to discuss initiatives to reduce the deaths and instances of toxicity resulting from the sedative-hypnotic category, especially the fast-acting barbiturates (secobarbital, amobarbital, and pentobarbital). DEA has begun a field survey of all DEA, DIU, State and local cases regarding abuse, diversion, and arrests involving these substances to determine the problem and support any action to be taken, either by DEA or FDA. Also, detailed review and analysis of DEA's system of reports from medical examiners, DAWN (Drug Abuse Warning Network) and manufacturing statistics will be included in this review. Similar activity is being conducted by NIDA and FDA. It is expected these reviews will be completed by the end of June 1977. At that time, based upon the information gathered, all interested parties (primarily ODAP, NIDA, FDA, and DEA) will determine an appropriate course of action. Potential actions discussed thus far have been restricting usage to hospitals, removal from the market, and greater efforts by DEA overseas to prevent foreign material being illicitly smuggled into the United States. Independent of this review, DEA on May 6, 1977, published in the Federal Register, the proposed 1977 quotas for the Schedule II barbiturates. These quotas would permit significantly less material to be manufactured in 1977 than in |