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Nomination of Robert Califf to Serve As Fda Commissioner S. HRG. 114–717 NOMINATION OF ROBERT CALIFF TO SERVE AS FDA COMMISSIONER HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED FOURTEENTH CONGRESS FIRST SESSION ON NOMINATION OF ROBERT CALIFF TO SERVE AS FDA COMMISSIONER NOVEMBER 17, 2015 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 97–694 PDF WASHINGTON : 2018 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 Nov 24 2008 11:51 Jan 25, 2018 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 S:\DOCS\97694.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 BARBARA A. MIKULSKI, Maryland JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania SUSAN COLLINS, Maine AL FRANKEN, Minnesota LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado MARK KIRK, Illinois SHELDON WHITEHOUSE, Rhode Island TIM SCOTT, South Carolina TAMMY BALDWIN, Wisconsin ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts BILL CASSIDY, M.D., Louisiana DAVID P. CLEARY, Republican Staff Director EVAN SCHATZ, Minority Staff Director JOHN RIGHTER, Minority Deputy Staff Director (II) VerDate Nov 24 2008 11:51 Jan 25, 2018 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 S:\DOCS\97694.TXT CAROL HELPN-004 with DISTILLER CONTENTS STATEMENTS TUESDAY, NOVEMBER 17, 2015 Page COMMITTEE MEMBERS Alexander, Hon. Lamar, Chairman, Health, Education, Labor, and Pensions Committee, opening statement ........................................................................... 1 Murray, Hon. Patty, a U.S. Senator from the State of Washington ................... 3 Burr, Hon. Richard, a U.S. Senator from the State of North Carolina ............... 5 Scott, Hon. Tim, a U.S. Senator from the State of South Carolina ..................... 6 Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode Island ...... 16 Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia ....................... 18 Warren, Hon. Elizabeth, a U.S. Senator from the State of Massachusetts ........ 20 Prepared statement .............................................................................................. 22 Roberts, Hon. Pat, a U.S. Senator from the State of Kansas .............................. 23 Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin .................. 25 Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana .......................... 27 Franken, Hon. Al, a U.S. Senator from the State of Minnesota .......................... 28 Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah ............................ 30 Bennet, Hon. Michael F., a U.S. Senator from the State of Colorado ................. 32 Sanders, Hon. Bernard, a U.S. Senator from the State of Vermont ................... 33 Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska ........................ 35 Casey, Hon. Robert P., Jr., a U.S. Senator from the State of Pennsylvania ...... 37 WITNESS Califf, Robert M., M.D., Deputy Commissioner for Medical Products and To- bacco, Department of Health and Human Services, Durham, NC ................... 7 Prepared statement .......................................................................................... 9 ADDITIONAL MATERIAL Statements, articles, publications, letters, etc.: Response by Robert M. Califf, M.D. to questions of: Senator Alexander ..................................................................................... 42 Senator Enzi .............................................................................................. 50 Senator Burr .............................................................................................. 50 Senator Isakson ......................................................................................... 53 Senator Isakson and Senator Murkowski ............................................... 56 Senator Isakson and Senator Murphy ..................................................... 56 Senator Collins .......................................................................................... 57 Senator Hatch ............................................................................................ 61 Senator Roberts ......................................................................................... 64 Senator Cassidy ......................................................................................... 68 Senator Murray ......................................................................................... 71 Senator Sanders ........................................................................................ 82 Senator Casey ............................................................................................ 86 Senator Bennet .......................................................................................... 90 Senator Baldwin ........................................................................................ 94 Senator Murphy ........................................................................................ 96 Senator Warren ......................................................................................... 99 Comprehensive Clinical Trials Conducted by Dr. Califf ............................... 112 Drug price comparisons in the United States and Canada ........................... 117 (III) VerDate Nov 24 2008 11:51 Jan 25, 2018 Jkt 000000 PO 00000 Frm 00003 Fmt 0486 Sfmt 0486 S:\DOCS\97694.TXT CAROL HELPN-004 with DISTILLER VerDate Nov 24 2008 11:51 Jan 25, 2018 Jkt 000000 PO 00000 Frm 00004 Fmt 0486 Sfmt 0486 S:\DOCS\97694.TXT CAROL HELPN-004 with DISTILLER NOMINATION OF ROBERT CALIFF TO SERVE AS FDA COMMISSIONER TUESDAY, NOVEMBER 17, 2015 U.S. SENATE, COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, Washington, DC. The committee met, pursuant to notice, at 10:05 a.m., in room SD–430, Dirksen Senate Office Building, Hon. Lamar Alexander, chairman of the committee, presiding. Present: Senators Alexander, Burr, Isakson, Collins, Murkowski, Kirk, Scott, Hatch, Roberts, Cassidy, Murray, Mikulski, Sanders, Casey, Franken, Bennet, Whitehouse, Baldwin, Murphy, and War- ren. OPENING STATEMENT OF SENATOR ALEXANDER The CHAIRMAN. The HELP Committee will come to order. Today we’re reviewing the nomination of Dr. Robert Califf to serve as Commissioner of Food and Drugs. Dr. Califf, welcome. Congratulations on your nomination. Wel- come to you and to your family members. We’re glad they have been able to come up, some of them from Columbia, SC, and I en- joyed having the opportunity to meet with you in my office. If you’re confirmed to lead the Food and Drug Administration as its Commissioner, you will be in charge of steering the agency re- sponsible for the safety and effectiveness of our Nation’s medical products and protecting our country’s food supply. This is a huge job. The FDA affects nearly every single American almost every day and regulates about a quarter of all of our consumer spending in the United States, over $4 trillion annually. It is responsible for product areas as diverse as prescription drugs for humans and ani- mals, medical devices, biologics, cosmetics, over-the-counter medi- cations, food, and tobacco. It’s a vital mission, and we all want to make sure that the right person is leading it. The President has nominated you to do that job, and like every full-time nominee, you’ve been through an ex- haustive process to make sure that you don’t have any conflicts of interest or other problems in your background. If you’ll permit me, I had the privilege of coming before this com- mittee about 24 or 25 years ago and sitting in the chair where you sit. It’s not always a pleasant experience. One of the Democratic Senators said to me, ‘‘Governor’’—my family was sitting where yours is—said to me, ‘‘Governor Alexander, I’ve heard some very (1) VerDate Nov 24 2008 11:51 Jan 25, 2018 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\DOCS\97694.TXT CAROL HELPN-004 with DISTILLER 2 disturbing things about you, but I don’t think I’ll bring them up this morning,’’ and Senator Kassebaum leaned over and said, ‘‘Well, Howard, I think you just did.’’ And then he held me up for 3 months. I don’t expect that would be happening with you, because like every full-time nominee, you’ve been through an exhaustive process to make sure of the conflicts of interest, as I said. Before the Presi- dent announced your nomination, there was an extensive vetting process by the White House and the FBI. You submitted paperwork to the Office of Government Ethics— that’s been carefully reviewed—including your financial informa- tion. They found several recusals, which you have committed to do, so there wouldn’t be any remaining conflicts of interest that would prevent you from doing your job, in the opinion of the Office of Gov- ernment Ethics. The form you submitted is public. It includes every source of income over $200 and every asset worth more than $1,000 and every potential conflict that the Office of Government Ethics determined would require a recusal. I’m going through this so people will
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