1 UNITED STATES OF AMERICA DRUG ENFORCEMENT ADMINISTRATION + + + + + PUBLIC MEETING + + + + + PROCEDURES FOR THE SURRENDER OF UNWANTED CONTROLLED SUBSTANCES BY ULTIMATE USERS + + + + + WEDNESDAY JANUARY 19, 2011 + + + + + The Public Meeting was held in the Grand Ballroom of the Renaissance Mayflower Hotel, 1127 Connecticut Avenue N.W., Washington, D.C., 20036 at 9:00 a.m., Mark Caverly, Moderator, presiding. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 2 T A B L E O F C O N T E N T S Joseph T. Rannazzisi, Deputy Assistant Administrator, DEA Office of Diversion Control ........................................... 4 Emcee: Mark Caverly, Section Chief, DEA Liaison and Policy Section.. ...............12 Colin Clark, Program Analyst, DEA Regulatory Drafting Unit ............................. 16 Timothy P. Condon, Science Policy Advisor, Office of National Drug Control Policy .... 32 Douglas F. Gansler, Attorney General, State of Maryland .................................. 56 Richard Stanek, Ed Hutchinson, Stephanie Garlock, National Sheriffs' Association ... 68 Lonnie Grabowska, Chief Agent, North Dakota Bureau of Criminal Investigations ......... 94 Roy E. McKinney, Director, Maine Drug Enforcement Agency ....................... 133 Presentations from the Registered Public Marcie Bough ............................. 158 Steve Brachman ........................... 171 David Case ............................... 191 Cynthia Finley ........................... 203 Philip Burgess ........................... 209 Dave Galvin .............................. 218 Doug Hebert .............................. 228 Shirley Reitz ............................ 240 Daniel Turissini ......................... 252 Stevan Gressitt .......................... 263 Nadine You ............................... 272 Sierra Fletcher .......................... 280 Mary Hendrickson ......................... 291 Jeanie Jaramillo ......................... 308 Derrick Bell ............................. 321 John Waffenschmidt ....................... 331 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 3 Open Microphone Claudia Schlosberg ....................... 338 Susan Boehme............................. 340 Selin Hoboy.............................. 345 Charlene Aiduks.......................... 352 Mr. Parham............................... 356 Adjourn...................................359 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 4 1 P-R-O-C-E-E-D-I-N-G-S 2 8:59 a.m. 3 MR. RANNAZZISI: Good morning. 4 Thank you for coming out on this dreary 5 Washington morning. 6 A bit of a housekeeping note. If 7 everyone would please silence all their 8 communication devices, any computers, whatever 9 the device you carry that's going to make 10 noise and interrupt the speakers or the 11 audience. I appreciate you all doing that 12 now. 13 My name is Joe Rannazzisi. I'm 14 the Deputy Assistant Administrator for the DEA 15 Office of Diversion Control. On behalf of 16 Administrator Michelle Leonhart and the more 17 than 9600 men and women of the Drug 18 Enforcement Administration, welcome to the DEA 19 public meeting to discuss the development of 20 procedures for the surrender of unwanted 21 controlled substances by ultimate users and 22 long-term care facilities for disposal. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 5 1 Specifically, this meeting is 2 intended to allow all interested persons, the 3 general public, ultimate users, health care 4 professionals, pharmaceutical industry groups, 5 retail pharmacies, regulators, law 6 enforcement, reverse distributors, and all 7 others to express their ideas and views on the 8 most safe and effective method for the 9 transfer and disposal of pharmaceutical 10 controlled substances in compliance with the 11 Controlled Substances Act and with the new 12 public law, 111-273, the Secure and 13 Responsible Drug Disposal Act of 2010. 14 And I want to take this 15 opportunity today to thank Representatives Jay 16 Inslee, Lamar Smith, Bart Stupak, and James 17 Moran, and Senators Amy Klobuchar, John 18 Cornyn, Chuck Grassley, and Sherrod Brown for 19 their leadership in passing this legislation. 20 This is the first opportunity for 21 public comment since the passage of this act. 22 The public will get a second opportunity to NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 6 1 provide written comments after a Notice of 2 Proposed Rulemaking is published in the near 3 future. 4 All statements that are made today 5 will be transcribed and incorporated into a 6 formal record of this meeting that will be 7 posted on the DEA website. 8 We're interested in hearing your 9 views, and we look forward to all of your 10 presentations. 11 To get a view of why 12 pharmaceutical controlled substance disposal 13 is of great concern, let's look at some 14 statistics. 15 The 2009 National Survey on Drug 16 Use and Health data related to prescription 17 drug abuse is alarming. Seven million 18 Americans age 12 and older abuse 19 psychotherapeutic drugs for non-medical 20 purposes. That was up 13 percent in just one 21 year. 22 5.3 million abuse narcotic pain NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 7 1 relievers for non-medical reasons. 2.6 2 million age 12 and older initiated for the 3 first time with psychotherapeutic drugs last 4 year. This averages to more than 7,000 per 5 day. 6 There was an increase in 98.4 7 percent of ER visits attributed to 8 pharmaceuticals alone, yet there was no 9 significant increase in ER visits related to 10 cocaine, heroin, marijuana, or 11 methamphetamine. 12 The number of people seeking 13 treatment for pain reliever abuse is up more 14 than six fold in the age category 18 to 34. 15 Every day, 2500 teens on average use 16 prescription drugs to get high for the first 17 time, and 16 percent of the teens who abuse 18 pain relievers did so before the age of 15. 19 62 percent of those surveyed 20 believe that teens got their prescription 21 medications from where? Their family's own 22 medicine cabinet for free. NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 8 1 Every leading indicator reflects a 2 common theme. America has a serious drug 3 problem, prescription drug problem, and the 4 problem is getting worse. 5 As the statistics reveal, one 6 contributing factor to this problem is the 7 household medicine cabinet. Prior to the 8 passage of the Secure and Responsible Drug 9 Disposal Act of 2010, DEA did not have the 10 authority to promulgate regulations to allow 11 an ultimate user to deliver controlled 12 substances to an authorized entity for 13 disposal. 14 There was confusion among the 15 public concerning the proper method to dispose 16 of pharmaceuticals. 17 Most U.S. communities did not 18 routinely offer opportunities to properly 19 dispose of unused, unwanted, or expired 20 pharmaceuticals or pharmaceutical controlled 21 substances. 22 As a result, many people kept the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 9 1 drugs in their households because they didn't 2 know how to dispose of them. The household 3 medicine cabinet has become a free source of 4 supply for non-medical users. 5 Now, local and state law 6 enforcement agencies, regulators, and 7 community groups have been addressing this 8 problem for years. Law enforcement and their 9 community partners conducted local, county, 10 and statewide take-back programs that 11 collected unused pharmaceuticals. These take- 12 back programs involved duly authorized law 13 enforcement officials collecting unused 14 pharmaceuticals from the public. 15 Unfortunately, these events were 16 not available in every community, and were 17 not, in many cases, regularly scheduled 18 programs. 19 Most recently, DEA, in partnership 20 with state and local law enforcement agencies, 21 regulators, community leaders, and local 22 governments, conducted a nation-wide NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 10 1 prescription pharmaceutical controlled 2 substance collection and disposal initiative 3 in September of 2010. 4 The collaborative effort with the 5 International Association of the Chiefs of 6 Police, National Association of Attorneys 7 General, National District Attorneys 8 Association, the Federation of State Medical 9 Boards, National Association of Boards of 10 Pharmacy, and the Partnership for a Drug-Free 11 America resulted in the collection of 12 approximately 244,000 pounds of 13 pharmaceuticals from the public by 14 approximately 3,000 agencies out of 4,000 15 collection locations. 16 We'll be conducting another 17 nationwide initiative on April 30, 2011, and 18 every six months thereafter, until we have 19 disposal regulations in place. 20 Although serving a public need, 21 these initiatives are temporary measures and 22 do not take the place of a uniform, widely NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 11 1 available disposal program. 2 However, the passage of the Secure 3 and Responsible Drug Disposal Act has provided 4 DEA with the authority to promulgate 5 regulations to create a system for the safe 6 and secure transfer of pharmaceutical 7 controlled substances for disposal. 8 This hearing is the first step, or 9 this meeting is the first step towards the 10 creation of these regulations. 11 I know that some of you have 12 traveled great distances to be here and to be 13 heard, and I thank you.