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Examining the Increase in Drug Shortages Hearing EXAMINING THE INCREASE IN DRUG SHORTAGES HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS FIRST SESSION SEPTEMBER 23, 2011 Serial No. 112–88 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 77–032 PDF WASHINGTON : 2013 For sale by the Superintendent of Documents, U.S. Government Printing 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 Aug 31 2005 13:50 Mar 13, 2013 Jkt 037690 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 F:\112-08~4\112-88~1 WAYNE COMMITTEE ON ENERGY AND COMMERCE FRED UPTON, Michigan Chairman JOE BARTON, Texas HENRY A. WAXMAN, California Chairman Emeritus Ranking Member CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan ED WHITFIELD, Kentucky Chairman Emeritus JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York MARY BONO MACK, California FRANK PALLONE, JR., New Jersey GREG WALDEN, Oregon BOBBY L. RUSH, Illinois LEE TERRY, Nebraska ANNA G. ESHOO, California MIKE ROGERS, Michigan ELIOT L. ENGEL, New York SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas Vice Chairman DIANA DEGETTE, Colorado JOHN SULLIVAN, Oklahoma LOIS CAPPS, California TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas BRIAN P. BILBRAY, California JAY INSLEE, Washington CHARLES F. BASS, New Hampshire TAMMY BALDWIN, Wisconsin PHIL GINGREY, Georgia MIKE ROSS, Arkansas STEVE SCALISE, Louisiana JIM MATHESON, Utah ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina CATHY MCMORRIS RODGERS, Washington JOHN BARROW, Georgia GREGG HARPER, Mississippi DORIS O. MATSUI, California LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin Islands BILL CASSIDY, Louisiana KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky PETE OLSON, Texas DAVID B. MCKINLEY, West Virginia CORY GARDNER, Colorado MIKE POMPEO, Kansas ADAM KINZINGER, Illinois H. MORGAN GRIFFITH, Virginia 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 EDOLPHUS TOWNS, New York MIKE ROGERS, Michigan ELIOT L. ENGEL, New York SUE WILKINS MYRICK, North Carolina LOIS CAPPS, California TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas PHIL GINGREY, Georgia TAMMY BALDWIN, Wisconsin ROBERT E. LATTA, Ohio MIKE ROSS, Arkansas CATHY MCMORRIS RODGERS, Washington JIM MATHESON, Utah LEONARD LANCE, New Jersey HENRY A. WAXMAN, California (ex officio) BILL CASSIDY, Louisiana BRETT GUTHRIE, Kentucky JOE BARTON, Texas FRED UPTON, Michigan (ex officio) (II) VerDate Aug 31 2005 13:50 Mar 13, 2013 Jkt 037690 PO 00000 Frm 00002 Fmt 0486 Sfmt 5904 F:\112-08~4\112-88~1 WAYNE CONTENTS Page Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement ................................................................... 1 Prepared statement .......................................................................................... 3 Hon. John Shimkus, a Representative in Congress from the State of Illinois, opening statement ................................................................................................ 5 Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey, opening statement .......................................................................... 5 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement ............................................................................. 6 Hon. Fred Upton, a Representative in Congress from the State of Michigan, prepared statement .............................................................................................. 158 Hon. John D. Dingell, a Representative in Congress from the State of Michi- gan, prepared statement ...................................................................................... 160 Hon. Edolphus Towns, a Representative in Congress from the State of New York, prepared statement .................................................................................... 161 WITNESSES Howard K. Koh, Assistant Secretary of Health, Department of Health and Human Services ................................................................................................... 7 Prepared statement .......................................................................................... 11 Jonathan M. Kafer, Vice President Sales and Marketing, Teva Health Sys- tems ....................................................................................................................... 66 Prepared statement .......................................................................................... 69 John M. Gray, President and CEO, Healthcare Distribution Management Association ............................................................................................................ 78 Prepared statement .......................................................................................... 80 Kevin J. Colgan, Corporate Director of Pharmacy, Rush University Medical Center, on behalf of the American Society of Health-System Pharmacists .... 87 Prepared statement .......................................................................................... 89 Mike Alkire, Chief Operating Officer, Premier, Inc. ............................................. 101 Prepared statement .......................................................................................... 103 W. Charles Penley, Chair, Government Relations Committee, American Soci- ety of Clinical Oncology ....................................................................................... 117 Prepared statement .......................................................................................... 120 Richard Paoletti, Vice President, Operations: Pharmacy, Laboratory, and Ra- diology, Lancaster General Health ..................................................................... 131 Prepared statement .......................................................................................... 133 Robert S. DiPaola, Director, The Cancer Institute of New Jersey ...................... 141 Prepared statement .......................................................................................... 144 SUBMITTED MATERIAL Statement, dated September 23, 2011, of the National Coalition for Cancer Research, submitted by Mr. Pallone ................................................................... 25 Statement, dated September 23, 2011, of the National Community Phar- macists Association, submitted by Mr. Pitts ...................................................... 32 Letter, dated September 22, 2011, from J. Evan Sadler, President, American Society of Hematology, to subcommittee leadership, submitted by Mr. Pitts . 35 Statement, dated September 23, 2011, of the Generic Pharmaceutical Associa- tion, submitted by Mr. Pitts ................................................................................ 39 Statement, dated September 23, 2011, of Fight Colorectal Cancer, submitted by Mr. Pallone ...................................................................................................... 151 (III) VerDate Aug 31 2005 13:50 Mar 13, 2013 Jkt 037690 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 F:\112-08~4\112-88~1 WAYNE VerDate Aug 31 2005 13:50 Mar 13, 2013 Jkt 037690 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 F:\112-08~4\112-88~1 WAYNE EXAMINING THE INCREASE IN DRUG SHORTAGES FRIDAY, SEPTEMBER 23, 2011 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. The subcommittee met, pursuant to call, at 9:36 a.m., in room 2322 of the Rayburn House Office Building, Hon. Joseph Pitts (chairman of the subcommittee) presiding. Members present: Representatives Pitts, Burgess, Shimkus, Myrick, Murphy, Blackburn, Gingrey, Lance, Cassidy, Guthrie, Walden, Pallone, Dingell, Schakowsky, Matheson, DeGette, and Waxman (ex officio). Staff present: Clay Alspach, Counsel, Health; Ray Baum, Senior Policy Advisory/Director of Coalitions; Marty Dannenfelser, Senior Advisor, Health Policy and Coalitions; Andy Duberstein, Special Assistant to Chairman Upton; Debbee Keller, Press Secretary; Jeff Mortier, Professional Staff Member; Katie Novaria, Legislative Clerk; John O’Shea, Professional Staff Member, Health; Chris Sarley, Policy Coordinator, Environment and Economy; Alan Slobodin, Deputy Chief Counsel, Oversight; Heidi Stirrup, Health Policy Coordinator; John Stone, Associate Counsel; Phil Barnett, Democratic Staff Director; Stephen Cha, Democratic Senior Profes- sional Staff Member; Alli Corr, Democratic Policy Analyst; Eric Flamm, FDA Detailee; Ruth Katz, Democratic Chief Public Health Counsel; Elizabeth Letter, Democratic Assistant Press Secretary; and Karen Lightfoot, Democratic Communications Director and Senior Policy Advisor. Mr. PITTS. This subcommittee will come to order. The chair rec- ognizes himself for 5 minutes for an opening statement. OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REP- RESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA In 2005, 61 drug shortages were reported to FDA.
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