FORT WORTH, TEXAS
FEBRUARY 5 – 7, 2002

The Drug Enforcement Administration sponsored the Tenth Pharmaceutical Industry Conference in Fort Worth, Texas on February 5 – 7, 2002. The Conference focused in large part upon enhancing communication and continued cooperation between government and the corporate sector and strengthening the relationship between DEA and its industry counterparts. The Conference served as an effective means of highlighting critical issues involving controlled substances.

The Tenth Pharmaceutical Industry Conference was the largest conference to date, with representatives from 62 industry firms (including their affiliated associations), totaling one hundred fifty-two (152) attendees. The Conference is regarded as an overall success.

• Welcome and Introductory Remarks
   
• Drug Diversion Overview
   
• Exploring Solutions to In-Transit Thefts 
  Industry/Carriers Discussion/Perspectives Panel
   
• Controlled Substances Ordering System Update (panel discussion)
   
• OD Website & Future Enhancements
   
• Regulatory Update
   
• The Corporate Role in –
  Ethics, Advertising, Marketing and Promotion (panel discussion)
   
• Working Lunch – Dr. Mary Anne Bobinski, Keynote Speaker
  Director, Health, Law and Policy Institute, University of Houston Law Center
   
• Determining Legitimate Need, Narcotic Raw Material Issues, Debunking Quota Myths, Scheduling Actions, Abuse Liability Testing
   
  • Legitimate Medical Use
  • Debunking Quota Myths
  • Scheduling Actions
  • Abuse Liability Testing
     
• Prescription Drug Diversion Initiative
   
• Associations/Industry Concerns (panel and open discussion)
   
• Closing Remarks

Acting Special Agent-in-Charge Francis E. Seib, Dallas Field Division, opened the Conference and welcomed the participants to Fort Worth, Texas and to the DEA Pharmaceutical Industry Conference. He then introduced Deputy Assistant Administrator Laura Nagel.

Mrs. Nagel noted the large industry turnout at the Conference as very encouraging. She stated the Conference provides an excellent opportunity for DEA and Industry to build upon the progress and cooperation shared. In covering the Conference objectives, she expressed her excitement about electronic commerce initiatives being undertaken by DEA with regard to CSOS and EPCS. She cited a number of mutual concerns for DEA and the Healthcare profession, particularly in-transit thefts, ethics, advertising and marketing. The voluntary cooperation of Industry is essential to DEA’s initiatives and strategies in addressing diversion control. Mrs. Nagel closed by encouraging continuing dialogue and working partnerships among DEA, industry and the affiliated associations.

Ms. Nagel then introduced Patricia Good, Chief, Liaison and Policy Section. Ms. Good introduced DEA Headquarters and Field Staff present, highlighted key topics to be covered during the Conference and provided administrative details.

A video titled "Drug Store Cowboy" depicting a prescription-shopping ring was shown at the end of Ms. Good’s remarks.

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Richard Seidel, Deputy Chief, DEA Office of Drug Operations, provided an overview of pharmaceutical drug abuse and diversion trends. His presentation covered legitimate controlled substances and included current drug abuse trend data, legitimate controlled substances appearing in the illicit market, most frequently prescribed controlled substances and other related information.

Statistical data derived from 4 primary information networks (HHS/SAMSHA 1999 Household Survey, DEA Diversion Quarterly Reports, DAWN and Drug Topics) was presented. The Substance Abuse and Mental Health Services Administration (SAMSHA)) annually conducts the National Household Survey on Drug Abuse by mailing out approximately 70,000 drug abuse questionnaires. According to the survey, approximately 14 million (6.3% of the population) people in the U.S. were current illicit drug users. 3.8 million people have used prescription type psychotherapeutic drugs for non-medical reasons (drugs obtained by either no prescription or used legitimately prescribed drugs for abuse purposes). The most dramatic increase in non-medical drug use was among ages 12-17 and 18-25. Over 50% of 12^th graders have abused drugs in their lifetime. Even more alarming is the 25 – 30% of 8^th graders reported to have abused prescription drugs in their lifetime. This data represents some of the more critical results of the survey, which points to increases in the diversion, and abuse of controlled substances.

Drug Trend data based on Quarterly Reports prepared by DEA Field Offices indicate the most commonly abused and diverted controlled substances are Hydrocodone products (Lortab, Lorcet, and Vicodin), Benzodiazepines (Valium and Xanax and generics), Oxycodone products, Hydromorphone and Ketamine. According to the most recent DAWN data, Cocaine is the most abused drug. The most abused licit drugs are Benzodiazepines, Hydrocodone and Oxycodone.

Methods of diversion and investigative leads followed by DEA when initiating investigations were also covered. It was pointed out that the controlled substances registrant population currently totals over 1 million, not including chemical registrants. The Diversion Investigator work force totals less than 400 field Investigators. During fiscal year 2001, over 3000 investigations were initiated domestically.

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This session featured a panel discussion chaired by Mike Moy, Chief, DEA Drug Operations Section. Mr. Moy opened the session and introduced the subject matter. He began his discussion by providing a synopsis on research he had conducted via the Internet and with other government agencies (e.g., DOD and NRC) on the subject of in-transit/cargo thefts. His research specifically focused on the shipping of valuable and dangerous commodities, which DEA and the other agencies are also engaged in. One of the things Mr. Moy concluded in his research was that these other government agencies, DEA and the pharmaceutical industry share both regulatory and policy considerations in common. He acknowledged that in-transit thefts have long been a problem that will not go away. Overall, his research concluded that the commodities that we deal with daily (e.g., controlled substances) should be safeguarded from diversion. It was pointed out how historically cargo thefts represent one of the weakest links in the global supply chain. Given the volume and significance of in-transit thefts and the relative value of pharmaceuticals, this is an area that requires close attention. Thus, sharing of ideas and cooperation among DEA, the pharmaceutical industry and industry associations is vital. Statistical data was provided, along with examples of situations in which thefts/losses have or can occur, along with preventive steps to deter these situations (e.g., background checks, video cameras, etc.).

Mr. Moy introduced the panel, which was comprised Maureen O’Keefe, Group Supervisor, DEA Camden Resident Office, Rodney Bias, Director, Security and Regulatory Affairs and Chris Zimmerman, Senior Director, Security and Regulatory Affairs, both with Amerisource Bergen; and Kevin Johnson, Director, Corporate Security and John Bostic, Senior Manager, Corporate Security, both representing Consolidated Freightways.

Group Supervisor Maureen O’Keefe provided a case presentation in which numerous in-transit thefts of controlled substances were uncovered. The matter involved the cooperative efforts of the DEA Camden Diversion Group, FBI, AmeriSource Bergen and the Philadelphia Police Department. The investigation revealed a small organization involved in large volume controlled substances thefts facilitated through the employees of respective trucking companies used by AmeriSource Bergen. Ms. O’Keefe’s presentation was informative and clearly demonstrated how attention to detail during an investigation is critical. The case provided an excellent example of how easily an in-transit theft crime can be committed and what is needed to solve in-transit theft/loss cases. The cooperative efforts of the parties involved led to the successful conclusion of the investigation, including imprisonment of three defendants.

Chris Zimmerman and Rodney Bias, representing AmeriSource Bergen, provided an in-depth presentation on In-Transit Thefts and Losses. They outlined internal procedures incorporated by AmeriSource Bergen to prevent and detect in-transit losses, and appropriate action to be taken when in-transit losses occur. Their presentation included:

1. Defining and categorizing in-transit losses (e.g., shipping/receiving errors, concealed shortages, mis-shipments, vehicle thefts, etc.).
    
2. Noting the many different points where losses can occur (e.g., manufacturer packing, distributor shipping, etc.).
    
3. Addressing DEA shipping issues.
    
4. The issues of determining adequate security and the factors that impact in-transit losses were covered in detail.
    
5. The importance of communication between all parties involved in the shipping process was stressed. Close working relations and involvement at all different points in the chain are key to ensuring adequate security and when investigating in-transit theft related incidents.
    
6. Discussion regarding signature responsibility on the DEA Form 106, timeliness of reporting an in-transit loss, establishing a chain of custody policy and in-transit controlled substances storage.
    
7. Lastly, given the growing increase in contract carriers, emphasis was placed on providing education to carriers as an integral security factor, including the establishment of operational guidelines to reduce driver chances of being victimized.

Kevin Johnson and John Bostic of Consolidated Freightways provided a corporate security perspective from the Trucking Association. Corporate security faces many challenges, the largest being 5 billion dollars in losses annually in the high tech industry. Cargo thefts by themselves are linked to approximately 10 – 12 million dollars in losses annually. Some additional factors are that 70 per cent of cargo thefts occur during transportation and 80 per cent involve insider theft. There has been a major shift in organized crime activity from narcotics to cargo theft.

Consolidated Freightways has instituted several new safeguards including in-depth pre-employment screening of all personnel prior to employment, annual motor vehicle record reports, in-transit security alerts, increased awareness of high value shipments, security tracking of firearms transportation and a secret witness program. Solutions recommended by Consolidated Freightways include use of careful packaging in shipping (e.g., banding tubes, shrink wrapping 2 to 3 times) and avoidance of 3^rd party carriers where possible.

The issue of in-transit thefts/losses is regarded as one of such importance that attendees have requested that it be addressed in a separate conference or working group meeting.

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The panel was comprised of Patricia Good, Chief, Liaison and Policy Section, DEA, Steve Bruck, PEC Solutions, Kathy Sierra, McKesson Supply and Greg Knowles, Purdue Pharma.

Patricia Good opened the panel discussion and introduced Steve Bruck, Project Manager of PEC Solutions, Inc. PEC Solutions is the contractor hired by DEA to engineer the two key electronic commerce initiatives, Electronic Prescriptions for Controlled Substances (EPCS) and Controlled Substances Ordering System (CSOS). Mr. Bruck provided an explanation of both projects. Using digital signatures, EPCS will allow prescriptions to be transferred electronically and would eliminate paper requirements. CSOS will represent the replacement of DEA Form 222 in the electronic world. A core group comprised of DEA and industry representatives has been instrumental in developing standards for CSOS. Current participants in the pilot program are AmeriSource Bergen, McKesson, Purdue Pharma, Cardinal Health, Abbott Laboratories and HDMA.

CSOS is currently in Phase three of Transaction Processing. CSOS is expected to bring numerous benefits to the manufacturing, distribution and pharmacy communities, including elimination of errors, more line items on a single order, and more frequent orders. CSOS allows for keeping less product on the shelf so that smaller orders could be placed more frequently and at substantial cost savings to industry. It is anticipated that CSOS will be implemented during the first quarter FY 2004.

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James Pacella, Chief, DEA Registration and Program Support Section, provided an update on the Office of Diversion Control’s Website and Future Enhancements over the past six months. The Website has a number of DEA Forms available on line in Adobe Acrobat format. The forms are only partially interactive. The reader must complete the form, print locally, sign and mail the form to DEA. DEA Application Forms 224, 225, 363 and 510 are now available for new registrants. Also available are quota applications, quota year-end reports, and Import/Export Forms DEA-357 and 486. DEA Forms 236 and 486 for import/export of drug/chemical products Theft and Loss (DEA-106) and Drug Destruction (DEA-41) can also be accessed on line.

In the very near future, renewal applications, address changes, schedule/drug code changes, duplicate certificates and DEA –222 requests will be available on line. Long term plans include fully interactive reports and applications. Steps are underway to implement DEA’s Electronic Data Interchange (EDI), which will allow for the full electronic reporting of ARCOS data. The projected initial implementation date is in a time frame of December 31, 2002. Voluntary responses from industry are being evaluated. Following the system build, the program will be tested with selected firms and go into full operation.

An update of miscellaneous registration related issues, including mail delays due to the Anthrax situation, DEA-222’s and the Toll Free Call Center was provided. The appearance of the DEA Website site will change in the very near future to make navigation easier. The most current information available will be posted on the Website.

Patricia Good, Chief, DEA’s Liaison and Policy Section, provided an update of current regulatory issues and clarification on questionable regulatory matters. She noted that the entire Code of Federal Regulations is in the process of being rewritten in plain language. The contractor, ICF, has been assisting DEA with this project for one year. Ms. Good covered the Interim Rule defining reverse distributors as distributors and pointed out that the business activity of a Reverse Distributor is still considered distribution and requires the same records/reports as a distributor. With regard to the disposal of List 1 Chemicals by a Reverse Distributor, the use of the DEA Form 41 for destruction of List 1 Chemicals is not currently required under the CSA. For the benefit of Industry, Ms. Good outlined the established procedures for publishing Federal regulations. Clarification was provided on the issues regarding Long Term Care Facilities (LTCF) and their ability to independently store controlled substances. Although most LTCF’s are not presently registered with DEA, DEA regulations currently allow a LTCF to register with DEA, if licensed by its state to handle controlled substances. DEA registers LTCF’s in one of the following categories (e.g., retail pharmacy, hospital/clinic, mid-level practitioner or practitioner), based upon the type of state license issued and the activities authorized by the state license. It is projected that DEA will likely create some new registration category in the future to institutionalize LTCF’s controlled substance activities. Clarification regarding the transferring of controlled substance samples was provided. The Controlled Substances Act does not address samples. Simply put controlled substance samples are treated no differently in requirements for purchases and/or sales than any other controlled substances. Lastly, Ms. Good covered the subject of significant loss, which takes on different meaning in different circumstances. Differences relative to business activity, size of business, volume of controlled substances handled, etc., must all be taken into account in determining whether a loss is regarded as significant. The requirement is that the firms maintain accountability, which provides for detection of significant loss.

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Terrance Woodworth, Deputy Director, Office of Diversion Control, opened this segment (Panel Discussion) and introduced the Panel which included Frank Sapienza, Chief, Drug and Chemical Evaluation Section Dr. Richard Allman, Albert Einstein Medical Center.

Mr. Sapienza restated DEA’s 30-year historical opposition of direct to consumer advertising of controlled substances. He expressed disappointment in the resurgence of this practice by industry. After detailing DEA’s position and providing background information, he emphasized DEA’s serious concern with the issues of controlled substances prescription drug abuse and diversion, escalating prescribing and production of controlled substances and increase in the size of the controlled substances market. Direct to consumer advertising of controlled substances does in fact increase demand, which increases production, which increases availability, which leads to increased potential for diversion, abuse and public risks. It is for those reasons that DEA believes direct to consumer advertising of controlled substances is contrary to the spirit of the Controlled Substances Act.

The pharmaceutical industry’s spending on direct to consumer advertising was approximately 2.5 billion dollars in 2000. Between 1998 and 1999, direct to consumer advertising expenditures rose 38.5%. Since 1991, expenditures rose 3,300%. As a result of direct to consumer advertising of prescription drugs, prescription drugs is now the largest and fastest selling group of medicines. According to the National Institute for Healthcare Management, this group of drugs is also becoming more and more popular and abused. The whole basis for this is that there is a prescription drug abuse problem. Additional data was provided showing the corresponding dramatic increases in prescription drug abuse (e.g., 1999 NIDA Report which revealed approximately 9 million Americans (age 12 and older)) have used prescription drugs for non medical reasons in 1999). Other data indicates the misuse of prescription drugs may be the most common form of drug abuse among elderly.

Direct to consumer advertising has become more prevalent. The ongoing concern of the International Narcotics Control Board (INCB) with the over consumption of primarily psychotropic substances has led to the conclusion that the overall problem of prescription drug abuse is a shared responsibility among government, healthcare professionals and among industry to ensure that only that amount of medicine needed is produced, distributed and dispensed. The World Health Organization has communicated its concerns to DEA in this area as well and will be consulting with FDA and INCB. The issue of direct to consumer advertising of scheduled drugs is clearly one of international concern.

Dr. Richard Allman covered the subject of ethical obligations of physicians and why they do not always fit with industry practices. His discussion focused on what he viewed the proper relationship to be between physicians and the pharmaceutical industry. He noted that physicians and the pharmaceutical industry are two distinct groups whose work is aimed at two entirely different ends; for physicians, provision of patient care is the primary goal, while the pharmaceutical industry’s focus is always an increase in the market share. Medicine on the other hand is or should be focused upon the patient’s needs. Dr. Allman talked about what he viewed the roles of physicians and industry to be, specifically with regard to the appropriate use of controlled substances. He suggested that industry "back off" in its vigorous marketing ploys and allow the medical profession to be advocates for appropriate and necessary utilization. Dr. Allman provided very serious ethical considerations for industry and physicians and stressed that legitimate medical need is central. A major theme throughout his discussion was that physicians should be able to act in good conscience and in a medically appropriate way without fear, coercion or corporate enticement. Lastly, profits should not drive the motivation for how controlled substances are distributed.

Mr. Terry Woodworth began his discussion emphasizing that profits should not be the driving motivation for how controlled substances are distributed throughout the United States. The real reason as specified in the law is legitimate medical need. Sales are a piece of DEA’s formula in conjunction w/FDA in determining the quantities allowed to be produced for legitimate medical need in the US.

Marketing, promotion & advertising are of great strategic importance to the DEA and affect each and every level of the distribution system (including manufacturer, distributor, importer, exporter, physician, pharmacy, etc.). Control mechanisms in the law (e.g., records, quotas, the number of establishments allowed to be registered, etc,) are all impacted by marketing, promotion and advertising.

Mr. Woodworth reiterated DEA’s position of 30 years that it is inappropriate to advertise controlled substances directly to consumers. This conviction is held in view of potential harm caused by controlled substances and drug abuse problems witnessed historically. The scope of DEA’s position here is limited to controlled substances and does not include over the counter drugs or prescription drugs. The DEA position does not in any way prohibit or consider inappropriate, advertising controlled substances directly to practitioners and/or other health care professionals.

Mr. Woodworth summarized how historically, governments in general have arrived at drug control and dealt with the challenges presented in the marketing, advertising and promotion of these products. He used China, India and the United States’ handling of Opium, Morphine, Cocaine and other drugs and the advertising of these products as examples of how the problems associated with drug control can escalate. He discussed how the CSA established effective drug control in the United States and how the need for control is greater than that for free competition. In line with the CSA, Congress determined that DEA should provide for adequate and uninterrupted controlled substances supplies.

Mr. Woodworth discussed DEA’s requirement of effective controls by registrants in order to become and remain registered. The Constitutional issues relating to direct to consumer advertising were discussed briefly. Congress gave DEA authority to limit production quantities and the number of registrants who handle these substances. The need for control is greater.

In closing, DEA is not trying to prohibit the use of controlled substances. However, given legitimate demand for controlled substances and the abuse/dependence factors present, DEA has the responsibility of ensuring adequate domestic controlled substances supplies, while at the same time, monitoring registrants to prevent diversion. Educating persons about controlled substances is a shared responsibility among industry, the medical profession and the Federal government. The distribution of controlled substances in the United States should be motivated by legitimate medical need.

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Keynote Speaker Mary Anne Bobinski delivered a very timely and thought provoking keynote address to the Conference by tying together information covered in earlier presentations by the other speakers. Dr. Bobinski stressed the need for collaboration between the medical profession and the pharmaceutical industry in balancing both sides of the issues, specifically, the provision of adequate access to controlled substances, healthcare and information. She was well received by the audience who expressed very positive comments about her address.

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Frank Sapienza opened this session with a discussion of determining legitimate medical need for controlled substances, an issue that must be resolved to establish quotas for controlled substances. DEA is required by law to set annual production quotas for the estimated medical, scientific research and industrial needs in the US and to take into consideration controlled substances exports, inventories or stocks. This data is also used for international drug control related issues. The issue of determining legitimate medical need has been a challenging issue to DEA since its inception. Mr. Sapienza’s presentation focused on different approaches to establishing legitimate medical need, advantages and disadvantages, balancing of critical factors and future revision plans.

Information used by DEA to establish quotas is derived from 3 primary sources in the middle of the closed system, namely sales data (dosage form level), prescription audit data (what is actually prescribed), and information from FDA (IMS data such as anticipated new products/dosage forms, recalled products, new product indications, etc.). Drug utilization is also factored in to determine legitimate medical need. The advantage of using a sales data based system is that it generally appears to meet the current industry needs. Although this system is imperfect, it provides the materials needed by industry to meet retail level demands. This data is a general indicator of what is produced, distributed and consumed and is not based on projections or estimates. This method takes other factors into consideration (e.g., needs for research and development, production schedules and difficulties, introduction of new companies and products, waste, etc.). The negative aspect is that this data may not be truly representative of what the legitimate medical need for a particular substance is because it inherently includes extra materials that go to retail level (e.g., either materials diverted, abused or not properly prescribed, etc.). This system is not predictive and requires repeated revision based on additional data submitted.

Mr. Sapienza provided a comparison of various drug products, taking into account available prescription data, ARCOS data and year-end data and resulting quotas established for these products, noting there should be some general agreement at the manufacturer, distributor and retail levels over time. The comparison was done to show that in fact, no single system should be used to determine drug utilization and thus legitimate medical need, as factors may vary dependent upon a particular substance, its availability and many other variables. Finally, none of this defines what legitimate medical need really is. What it does indicate is what is produced, what is distributed and what is consumed.

An alternate approach for determining legitimate medical need is to look at disease prevalence (starting at the patient level), compared to other available data. Although there are clear advantages to this method, the difficulty in tracking sources of information and the possibilities of over or under estimation of legitimate medical need, does not provide for a balanced measure.

Mr. Sapienza covered briefly the methods utilized by the United Nations (UN) for determining legitimate medical need (morbidity and consumption methods) on a global basis. The UN has the difficult task of comparing the use of drug products between different countries. Based on exclusion of products in demand, new strains of products, lag time between cultivation and ultimate use, and losses occurring at differing states, there is evidence that the system is in need of revision. The noted drawbacks of both methods are that they provide for inaccurate assessments of legitimate medical need and have led to criticisms suggesting drug shortages.

Most recently, an international study was commissioned by the INCB to examine how supply/demand is calculated. Based upon its findings, new recommendations are being made on how reporting should be revised to better determine supply and demand, according to its guidelines. Additional information on this new system will be provided along with instructions at a later time. DEA proposed to meet with firms that provide raw material data to discuss the new system. It is regarded as a better system, which is more current and takes into account changes in narcotic raw material processing and medical use.

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Julie Tisinger’s presentation covered the top 20 quota related myths and provided clarification and background information helpful to the registrant public. She detailed special exceptions, distinguished registration business activities, quantitative data and answered questions relative to registrant reporting requirements. Industry representatives were strongly advised to contact DEA should any questions arise or further clarification be required. Mrs. Tisinger also provided direction regarding policy changes, year -end reports, quotas and other related issues.

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Frank Sapienza provided an overview of current DEA scheduling activities, including a brief review of the controlled substance scheduling process and criteria for scheduling. The issues that go into scheduling decisions along with the difficulties encountered were covered as well. Predictive versus reactive scheduling actions were also discussed. Other miscellaneous scheduling related information was covered, including where to obtain certain controlled substance related information, HHS’s role in scheduling actions and various data sources.

The only DEA scheduling action slated for this year is possibly the rescheduling of Buprenorphine from Schedule 5 to Schedule 3 to be used for narcotic addiction treatment. Petitions to decontrol the drugs Quazepam, Cybutramine and Meridia are also pending.

THC derivatives and Hemp were discussed. The CSA clearly defines and controls Marijuana but contains no definition for Hemp. This was not considered an issue until recently, when products derived from the uncontrolled portion of the plant (i.e., hemp brownies, beer, candy, clothing, etc.) that contained THC began to appear on the market.

Other miscellaneous scheduling related information was covered, including where to obtain certain controlled substances related information, reactive versus proactive scheduling, HHS’ role in scheduling actions along with other data sources.

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Dr. James H. Woods – College on Problems of Drug Dependence

Dr. Woods provided an overview of the role and history of the College on Problems of Drug Dependence (CPDD) along with some discussion regarding abuse liability testing. In existence since 1929, the CPPD is the longest standing group in the U.S. addressing problems of drug dependence and abuse. The CPDD’s role has evolved over the years into a membership organization which serves as an interface among governmental, industrial and academic communities. The CPDD further maintains liaisons with regulatory and research agencies, as well as educational, treatment, and prevention facilities in the drug abuse field. The CPDD also functions as a collaborating center of the World Health Organization.

The CPDD’s scientific and professional activities include an Annual Scientific Meeting with representatives of regulatory agencies, scientists, and clinical investigators from industry, academia and government. The College provides support for research and for drug dependence testing in animals in major university testing facilities sponsored by the College. The College also supports drug assessment activities that provide information to national and international government agencies, the pharmaceutical industry, academia and the public to assist in evaluating the dependence potential and or abuse liability of new drugs. The CPDD is involved in consultation activities and sponsors the journal Drug and Alcohol Dependence.

Robert Walsh, Chief, Regulatory Affairs Branch, Division of Treatment Research and Development at the National Institute on Drug Abuse (NIDA), Bethesda, Maryland, began his presentation with an explanation of NIDA’s mission. He explained that NIDA is mainly a research granting organization whose focus is purely research driven and which disseminates facts found based upon research. Mr. Walsh introduced the Prescription Drug Diversion Initiative, an effort undertaken by NIDA, in partnership with a number of organizations (American Association of Retired Persons, National Association of Chain Drug Stores and others). The Initiative includes a number of components, including a news conference, scientific meeting, publishing of research report, program announcement, etc.

The Prescription Drug Diversion Initiative was the direct result of recent drug abuse trend data that indicated significant increases in prescription drug abuse, across age and gender lines. NIDA’s Website was provided as a source for researching the extent of the problem, potential prevention approaches, ways to deal with drug abuse, etc.

Patricia Good, Chief, Liaison and Policy Section, introduced the Panel consisting of Diane Goyette, Healthcare Distribution Management Association, (HDMA); Mary Ann Wagner, National Association of Chain Drug Stores (NACDS); Marietta Niess, Director, Abbott Laboratories; and Mitchell Blackman, Capital Returns. This session is reserved as an open forum for industry and its affiliated associations to communicate any issues and concerns to DEA and to each other.

Diane Goyette, Director of Regulatory Affairs Program at HDMA (HDMA is a trade association representing healthcare product distribution in the U.S.) made the following very positive comments regarding the relationship between DEA and industry.

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Mary Ann Wagner, Vice President, Pharmacy Regulatory Affairs, NACDS represents owners and operators of U.S. chain drug stores, comprised of approximately 190 companies which fill 60% of outpatient prescriptions in the U.S. She described the working relationship between DEA and industry as a very good one, stating that most issues have been resolved over the years. Ms. Wagner’s comments are summarized as follows:

Marietta Niess, Director, Regulatory Compliance, Abbott Laboratories, acknowledged ongoing, positive working relations between DEA and industry.

Mitchell Blackman of Capitol Returns represents the Reverse Distribution industry, which is approximately 12 years old and includes approximately 38 members. Mr. Blackman noted the Reverse Distributor Association is a member of HDMA. The Reverse Distributor will soon become a designated DEA business activity and will no longer be classified as a regular Distributor. He acknowledged DEA’s support of the reverse distributor industry and the industry’s efforts to ensure secure methods of destroying outdated controlled substances. Other items mentioned by Mr. Blackman were as follows:

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Terry Woodworth, Deputy Director, Office of Diversion Control agreed with industry’s assessment that things have gotten better over the years. He noted the shared responsibility of DEA, industry and medical practitioners for drug abuse prevention and control. DEA is making efforts to place Diversion policy on its Website in order to provide consistent interpretation of its policies and procedures. These issues are being addressed at the Diversion Program Manger and Group Supervisor levels as well.

Methamphetamine issues continue to be a challenge for DEA and industry as the chemical law remains relatively new and its scope and oversight is very different from the closed system which regulates controlled substances. Regarding DEA funding for prescription monitoring programs, states will require serious help/support in carrying out these programs, otherwise they will not succeed. Program infrastructure is critical. Oxycontin robberies are of particular concern. It was recommended that a concept used in the past, the Pharmacy Theft Prevention Program be explored as a possible solution to preventing pharmacy robberies/burglaries. DEA will work closer with the reverse distributor industry to work out some of the existing issues. DEA will continue to solicit industry’s help in dealing the problem of prescription drug abuse. It was announced that DEA’s Diversion Control Program is being elevated to the divisional level which will result in greater focus on diversion related issues. Electronic commerce is one of the most important issues and will help resolve many of the difficulties relative to record keeping, reporting, etc. Security/In-Transit Loss related concerns will be addressed at the Working Group level. Again, there are no DEA scheduling actions anticipated over the next year. DEA will be working to address manufacturing and ARCOS issues. Mr. Woodworth thanked the attendees for their interest and participation and the Conference was called to a close.