S. HRG. 115–341 NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS COMMISSIONER OF FOOD AND DRUGS HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED FIFTEENTH CONGRESS FIRST SESSION ON EXAMINING THE NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS COMMISSIONER OF FOOD AND DRUGS APRIL 5, 2017 Printed for the use of the Committee on Health, Education, Labor, and Pensions ( Available via the World Wide Web: http://www.gpo.gov/fdsys/ U.S. GOVERNMENT PUBLISHING OFFICE 25–027 PDF WASHINGTON : 2018 VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS LAMAR ALEXANDER, Tennessee, Chairman MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania RAND PAUL, Kentucky AL FRANKEN, Minnesota SUSAN M. COLLINS, Maine MICHAEL F. BENNET, Colorado BILL CASSIDY, M.D., Louisiana SHELDON WHITEHOUSE, Rhode Island TODD YOUNG, Indiana TAMMY BALDWIN, Wisconsin ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts LISA MURKOWSKI, Alaska TIM KAINE, Virginia TIM SCOTT, South Carolina MAGGIE HASSAN, New Hampshire DAVID P. CLEARY, Republican Staff Director LINDSEY WARD SEIDMAN, Republican Deputy Staff Director EVAN SCHATZ, Minority Staff Director JOHN RIGHTER, Minority Deputy Staff Director (II) VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER CONTENTS STATEMENTS WEDNESDAY, APRIL 5, 2017 Page COMMITTEE MEMBERS Alexander, Hon. Lamar, Chairman, Committee on Health, Education, Labor, and Pensions, opening statement ....................................................................... 1 Murray, Hon. Patty, a U.S. Senator from the State of Washington, opening statement .............................................................................................................. 3 Murphy, Hon. Christopher, a U.S. Senator from the State of Connecticut ........ 6 Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming .................... 15 Sanders, Hon. Bernard, a U.S. Senator from the State of Vermont ................... 17 Young, Hon. Todd, a U.S. Senator from the State of Indiana ............................. 19 Kaine, Hon. Tim, a U.S. Senator from the State of Virginia ............................... 20 Scott, Hon. Tim, a U.S. Senator from the State of South Carolina ..................... 22 Warren, Hon. Elizabeth, a U.S. Senator from the State of Massachusetts ........ 24 Burr, Hon. Richard, a U.S. Senator from the State of North Carolina ............... 26 Casey, Hon. Robert P., Jr., a U.S. Senator from the State of Pennsylvania ...... 28 Paul, Hon. Rand, a U.S. Senator from the State of Kentucky ............................. 30 Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah ............................ 33 Bennet, Hon. Michael F., a U.S. Senator from the State of Colorado ................. 35 Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana .......................... 36 Franken, Hon. Al, a U.S. Senator from the State of Minnesota .......................... 38 Roberts, Hon. Pat, a U.S. Senator from the State of Kansas .............................. 40 Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin .................. 41 Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska ........................ 43 Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode Island ...... 45 Hassan, Hon. Margaret Wood, a U.S. Senator from the State of New Hamp- shire ....................................................................................................................... 47 WITNESS Gottlieb, Scott, M.D., Nominee to Serve as Commissioner of Food and Drugs, . 7 Prepared statement .......................................................................................... 10 ADDITIONAL MATERIAL Statements, articles, publications, letters, etc. Letters of Support ............................................................................................. 54 Response by Scott Gottlieb to questions of: Senator Alexander ..................................................................................... 59 Senator Murray ......................................................................................... 60 Senator Enzi .............................................................................................. 83 Senator Sanders ........................................................................................ 84 Senator Burr .............................................................................................. 86 Senator Casey ............................................................................................ 87 Senator Isakson ......................................................................................... 90 Senator Franken ........................................................................................ 92 Senator Paul .............................................................................................. 94 Senator Bennet .......................................................................................... 96 (III) VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00003 Fmt 5905 Sfmt 5905 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER Senator Collins .......................................................................................... 97 Senator Whitehouse .................................................................................. 100 Senator Cassidy ......................................................................................... 105 Senator Baldwin ........................................................................................ 106 Senator Hatch ............................................................................................ 107 Senator Murkowski ................................................................................... 109 Senator Murphy ........................................................................................ 110 Senator Roberts ......................................................................................... 113 Senator Warren ......................................................................................... 114 Senator Kaine ............................................................................................ 125 Senator Hassan ......................................................................................... 127 (IV) VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS COMMISSIONER OF FOOD AND DRUGS WEDNESDAY, APRIL 5, 2017 U.S. SENATE, COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, Washington, DC. The committee met, pursuant to notice, at 10:02 a.m. in room SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander, chairman of the committee, presiding. Present: Senators Alexander, Enzi, Burr, Paul, Cassidy, Young, Hatch, Roberts, Murkowski, Scott, Murray, Sanders, Casey, Franken, Bennet, Whitehouse, Baldwin, Murphy, Warren, Kaine, and Hassan. OPENING STATEMENT OF SENATOR ALEXANDER THE CHAIRMAN. The Senate Committee on Health, Education, Labor, and Pensions will please come to order. This morning, we are holding a hearing on the nomination of Dr. Scott Gottlieb to be the next Commissioner of Food and Drugs. Senator Murray and I will each have an opening statement then we will introduce Dr. Gottlieb. After his testimony, Senators will each have two rounds of 5-minute questions, if they wish to. Last year, the most important legislation that Congress enacted was the 21st Century Cures law. Those are not my words; they are Majority Leader McConnell’s words. The reason it was such an important bill is that it will drive for- ward research and the extraordinary medical miracles that are in the works and that have the potential to affect every American family. Dr. Francis Collins, at the National Institutes of Health, has talked about some of the discoveries that he predicts are possible in the next decade: Non-addictive painkillers; hearts rebuilt from our own stem cells; a universal flu vaccine; an HIV/AIDS vaccine; an artificial pancreas for diabetes patients who have spent decades injecting themselves with insulin. The key to making these miracles a reality is not just investment in research, but a regulatory process that is efficient and effective enough to bring safe discoveries to patients in a timely way. The Food and Drug Administration has always been important, but there has never been a more important time to capitalize on the significant funding Congress has given to medical research, and to realize the promise of 21st Century Cures. (1) VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER 2 Dr. Gottlieb, congratulations to you on your nomination. Wel- come to you and to your family members who are here. I hope you will introduce them at the appropriate time. We have enjoyed hav- ing the opportunity to visit with you in my office. If confirmed to lead the Food and Drug Administration as its commissioner, you will be in charge of steering the agency respon- sible for