IMPROVING PREDICTABILITY AND TRANSPARENCY IN DEA AND FDA REGULATION HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS SECOND SESSION APRIL 7, 2014 Serial No. 113–137 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PUBLISHING OFFICE 90–872 PDF WASHINGTON : 2015 For sale by the Superintendent of Documents, U.S. Government Publishing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING COMMITTEE ON ENERGY AND COMMERCE FRED UPTON, Michigan Chairman RALPH M. HALL, Texas HENRY A. WAXMAN, California JOE BARTON, Texas Ranking Member Chairman Emeritus JOHN D. DINGELL, Michigan ED WHITFIELD, Kentucky FRANK PALLONE, JR., New Jersey JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California GREG WALDEN, Oregon ELIOT L. ENGEL, New York LEE TERRY, Nebraska GENE GREEN, Texas MIKE ROGERS, Michigan DIANA DEGETTE, Colorado TIM MURPHY, Pennsylvania LOIS CAPPS, California MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois Vice Chairman JIM MATHESON, Utah PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina STEVE SCALISE, Louisiana JOHN BARROW, Georgia ROBERT E. LATTA, Ohio DORIS O. MATSUI, California CATHY MCMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin Islands GREGG HARPER, Mississippi KATHY CASTOR, Florida LEONARD LANCE, New Jersey JOHN P. SARBANES, Maryland BILL CASSIDY, Louisiana JERRY MCNERNEY, California BRETT GUTHRIE, Kentucky BRUCE L. BRALEY, Iowa PETE OLSON, Texas PETER WELCH, Vermont DAVID B. MCKINLEY, West Virginia BEN RAY LUJAN, New Mexico CORY GARDNER, Colorado PAUL TONKO, New York MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky ADAM KINZINGER, Illinois H. MORGAN GRIFFITH, Virginia GUS M. BILIRAKIS, Florida BILL JOHNSON, Ohio BILLY LONG, Missouri RENEE L. ELLMERS, North Carolina SUBCOMMITTEE ON HEALTH JOSEPH R. PITTS, Pennsylvania Chairman MICHAEL C. BURGESS, Texas FRANK PALLONE, JR., New Jersey Vice Chairman Ranking Member ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York MIKE ROGERS, Michigan LOIS CAPPS, California TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah PHIL GINGREY, Georgia GENE GREEN, Texas CATHY MCMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina LEONARD LANCE, New Jersey JOHN BARROW, Georgia BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin Islands BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida H. MORGAN GRIFFITH, Virginia JOHN P. SARBANES, Maryland GUS M. BILIRAKIS, Florida HENRY A. WAXMAN, California (ex officio) RENEE L. ELLMERS, North Carolina JOE BARTON, Texas FRED UPTON, Michigan (ex officio) (II) VerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00002 Fmt 0486 Sfmt 5904 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING CONTENTS Page Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement ................................................................... 1 Prepared statement .......................................................................................... 44 Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey, opening statement .......................................................................... 45 Hon. John D. Dingell, a Representative in Congress from the State of Michi- gan, opening statement ....................................................................................... 47 Hon. Fred Upton, a Representative in Congress from the State of Michigan, opening statement ................................................................................................ 47 Prepared statement .......................................................................................... 48 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, opening statement ............................................................................ 48 Prepared statement .......................................................................................... 66 Hon. Ed Whitfield, a Representative in Congress from the Commonwealth of Kentucky, opening statement ......................................................................... 67 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement .................................................................................... 67 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement ............................................................................. 68 WITNESSES Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services ......... 69 Prepared statement .......................................................................................... 72 Answers to submitted questions ...................................................................... 184 Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Department of Justice ............... 80 Prepared statement .......................................................................................... 82 Answers to submitted questions ...................................................................... 194 Nathan B. Fountain, Chair, Professional Advisory Board, Epilepsy Founda- tion of America ..................................................................................................... 122 Prepared statement .......................................................................................... 126 John M. Gray, President and Chief Executive Officer, Healthcare Distribution Management Association ..................................................................................... 134 Prepared statement .......................................................................................... 136 D. Linden Barber, Partner and Director, DEA Compliance and Litigation Practice, Quarles & Brady, LLP ......................................................................... 141 Prepared statement .......................................................................................... 143 Answers to submitted questions ...................................................................... 212 Wendy K.D. Selig, President and Chief Executive Officer, Melanoma Research Alliance ................................................................................................................. 155 Prepared statement .......................................................................................... 157 Scott Faber, Senior Vice President for Government Affairs, Environmental Working Group ..................................................................................................... 163 Prepared statement .......................................................................................... 165 SUBMITTED MATERIAL H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act of 2013, submitted by Mr. Pitts ................................................................... 2 H.R. 4250, the Sunscreen Innovation Act, submitted by Mr. Pitts ..................... 15 H.R. 4299, the Improving Regulatory Transparency for New Medical Thera- pies Act, submitted by Mr. Pitts ......................................................................... 41 (III) VerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING IV Page Letter of April 7, 2014, from Gina F. Adams, Corporate Vice President, Government Affairs, FedEx Corporation, to Mr. Upton, et al., submitted by Mrs. Blackburn ................................................................................................ 50 Statement of April 7, 2014, by the National Association of Chain Drug Stores, submitted by Mrs. Blackburn ............................................................................. 51 Letter of April 7, 2014, from Alliance to Prevent the Abuse of Medicines to Hon. Tom Marino and Mrs. Blackburn, submitted by Mrs. Blackburn ...... 64 Letter of April 4, 2014, from Brett M. Coldiron, President, American Academy of Dermatology Association to Mr. Pitts and Mr. Pallone, submitted by Mr. Whitfield ........................................................................................................ 108 Letter of April 7, 2014, from Bill Piper, Director, Office of National Affairs, Drug Policy Alliance, to Mr. Pitts and Mr. Pallone, submitted by Mr. Pallone .................................................................................................................. 120 Statement of April 7, 2014, by the Global Healthy Living Foundation, sub- mitted by Mr. Pitts .............................................................................................. 182 VerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING