REVIEW OF THE PROPOSED GENERIC DRUG AND BIOSIMILARS USER FEES AND FURTHER EXAM- INATION OF DRUG SHORTAGES HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS SECOND SESSION FEBRUARY 9, 2012 Serial No. 112–114 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 81–517 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 15:22 Jul 01, 2013 Jkt 037690 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 F:\112-11~1\112-11~1 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 15:22 Jul 01, 2013 Jkt 037690 PO 00000 Frm 00002 Fmt 0486 Sfmt 5904 F:\112-11~1\112-11~1 WAYNE CONTENTS Page Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement ................................................................... 1 Prepared statement .......................................................................................... 3 Hon. Tim Murphy, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement ................................................................... 4 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement ............................................................................. 4 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement .................................................................................... 5 Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey, opening statement .......................................................................... 16 Hon. John D. Dingell, a Representative in Congress from the State of Michi- gan, opening statement ....................................................................................... 17 Hon. Fred Upton, a Representative in Congress from the State of Michigan, prepared statement .............................................................................................. 170 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, prepared statement .......................................................................... 171 Hon. Cathy McMorris Rodgers, a Representative in Congress from the State of West Virginia, prepared statement ................................................................ 172 WITNESSES Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration .................................................................................... 18 Prepared statement .......................................................................................... 20 Answers to submitted questions ...................................................................... 173 Theresa Mullin, Director, Office of Planning and Informatics, Center for Drug Evaluation and Research 1 .................................................................................. Peter Beckerman, Senior Advisor, Office of Policy, Food and Drug Administra- tion 1 ...................................................................................................................... Valerie Jensen, Associate Director, Center for Drug Evaluation and Research, Drug Shortage Program, Food and Drug Administration 1 .............................. Heather Bresch, Chief Executive Officer, Mylan, Inc. .......................................... 97 Prepared statement .......................................................................................... 100 Answers to submitted questions ...................................................................... 189 David Gaugh, Vice President, Regulatory Sciences, Generic Pharmaceutical Association ............................................................................................................ 120 Prepared statement .......................................................................................... 122 Answers to submitted questions ...................................................................... 191 Bill Greene, Chief Pharmaceutical Officer, Pharmaceutical Services, Member, Pharmaceutical Sciences, St. Jude Children’s Research Hospital ................... 141 Prepared statement .......................................................................................... 144 Answers to submitted questions ...................................................................... 193 SUBMITTED MATERIAL Executive Summary of Society of Gynecologic Oncology’s Drug Shortage Sur- vey, dated September 2011, submitted by Mr. Burgess ................................... 8 Letter, dated January 6, 2012, from Dale P. Conner, Director, Division of Bioequivalence I, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health & Human Services, to Michael Dwyer, Azaya Therapeutics, submitted by Mr. Burgess .......................................................................................................... 14 Analysis, undated, of H.R. 1483, the Drug Safety Enhancement Act of 2011, submitted by Mr. Dingell .................................................................................... 46 (III) VerDate Aug 31 2005 15:22 Jul 01, 2013 Jkt 037690 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 F:\112-11~1\112-11~1 WAYNE IV Page Statement, dated February 9, 2012, of American Academy of Pediatrics, sub- mitted by Mr. Pitts .............................................................................................. 63 Statement, dated February 9, 2012, of American Society of Health-System Pharmacists, submitted by Mr. Pitts .................................................................. 69 Statement, dated February 9, 2012, of National Community Pharmacists Association, submitted by Mr. Pitts ................................................................... 73 Statement, dated February 7, 2012, of the Biotechnology Industry Organiza- tion, submitted by Mr. Pitts ................................................................................ 91 1 Ms. Mullin, Mr. Beckerman, and Ms. Jensen did not present statements for the record. VerDate Aug 31 2005 15:22 Jul 01, 2013 Jkt 037690 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 F:\112-11~1\112-11~1 WAYNE REVIEW OF THE PROPOSED GENERIC DRUG AND BIOSIMILARS USER FEES AND FUR- THER EXAMINATION OF DRUG SHORTAGES THURSDAY, FEBRUARY 9, 2012 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. The subcommittee met, pursuant to call, at 10:00 a.m., in room 2123 of the Rayburn House Office Building, Hon. Joe Pitts (chair- man of the subcommittee) presiding. Members present: Representatives Pitts, Burgess, Shimkus, Mur- phy, Gingrey, Latta, Lance, Cassidy, Pallone, Dingell, Towns, Engel, Capps, DeGette, and Waxman (ex officio). Staff present: Clay Alspach, Counsel, Health; Michael Beckerman, Deputy Staff Director; Nancy Dunlap, Health Fellow; Paul Edattel, Professional Staff Member, Health; Debbee Keller, Press Secretary;