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Nomination Andrew Von Eschenbach and Paul Decamp Hearing Committee on Health, Education, Labor, and Pensions United States Senat S. HRG. 109–816 NOMINATION OF ANDREW VON ESCHENBACH AND PAUL DECAMP HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED NINTH CONGRESS SECOND SESSION ON ANDREW VON ESCHENBACH, OF TEXAS, TO BE COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH AND HUMAN SERVICES PAUL DeCAMP, OF VIRGINIA, TO BE ADMINISTRATOR OF THE WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR AUGUST 1, 2006 Printed for the use of the Committee on Health, Education, Labor, and Pensions ( Available via the World Wide Web: http://www.access.gpo/congress/senate U.S. GOVERNMENT PRINTING OFFICE 30–085 PDF WASHINGTON : 2007 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) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001 VerDate 0ct 09 2002 11:14 Apr 24, 2007 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 S:\DOCS\30085.TXT SLABOR1 PsN: DENISE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS MICHAEL B. ENZI, Wyoming, Chairman JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland JOHNNY ISAKSON, Georgia JAMES M. JEFFORDS (I), Vermont MIKE DEWINE, Ohio JEFF BINGAMAN, New Mexico JOHN ENSIGN, Nevada PATTY MURRAY, Washington ORRIN G. HATCH, Utah JACK REED, Rhode Island JEFF SESSIONS, Alabama HILLARY RODHAM CLINTON, New York PAT ROBERTS, Kansas KATHERINE BRUNETT MCGUIRE, Staff Director J. MICHAEL MYERS, Minority Staff Director and Chief Counsel (II) VerDate 0ct 09 2002 11:14 Apr 24, 2007 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 S:\DOCS\30085.TXT SLABOR1 PsN: DENISE CONTENTS STATEMENTS TUESDAY, AUGUST 1, 2006 Page Enzi, Hon. Michael B., Chairman, Committee on Health, Education, Labor, and Pensions, opening statement ....................................................................... 1 Kennedy, Hon. Edward M., a U.S. Senator from the State of Massachusetts, opening statement ................................................................................................ 7 Hutchison, Hon. Kay Bailey, a U.S. Senator from the State of Texas ................ 10 Von Eschenbach, Andrew, nominee to be Commissioner of Food and Drugs, Department of Health and Human Services ...................................................... 11 Prepared statement .......................................................................................... 14 DeCamp, Paul, nominee to be Administrator of the Wage and Hour Division, Department of Labor ........................................................................................... 16 Prepared statement .......................................................................................... 18 ADDITIONAL MATERIAL Statements, articles, publications, letters, etc.: Letters of support: Mark B. Leahy, Medical Device Manufacturers Association ................. 3 Michael J. Fitzpatrick, The Nation’s Voice on Mental Illness (NAMI) . 3 Stephen J. Ubl, Advanced Medical Technology Association (AdvaMed) .............................................................................................. 4 Anthony J. Dennis, OMERIS ................................................................... 5 Edwin A. Mirand, New York State Cancer Programs Association, Inc. .......................................................................................................... 6 Charles A. Reinwald, Cancer Cure Coalition .......................................... 6 Letters submitted by Senator Clinton: Michael O. Leavitt ..................................................................................... 35 Andrew von Eschenbach ........................................................................... 36 Response by Andrew C. von Eschenbach to questions of: Senator Enzi .............................................................................................. 53 Senator Kennedy ....................................................................................... 66 Senator Gregg ............................................................................................ 78 Senator Burr .............................................................................................. 85 Senator DeWine ......................................................................................... 86 Senator Ensign .......................................................................................... 93 Senator Hatch ............................................................................................ 100 Senator Sessions ........................................................................................ 102 Additional questions of Senator Sessions for Andrew C. von Eschenbach .. 103 Response by Andrew C. von Eschenbach to questions of: Senator Dodd ............................................................................................. 104 Senator Harkin .......................................................................................... 116 Senator Mikulski ....................................................................................... 117 Senator Jeffords ......................................................................................... 120 Senator Bingaman ..................................................................................... 120 Senator Murray ......................................................................................... 129 Senator Reed .............................................................................................. 136 Senator Clinton ......................................................................................... 139 Additional questions of Senator Clinton for Andrew C. von Eschenbach .... 152 (III) VerDate 0ct 09 2002 11:14 Apr 24, 2007 Jkt 000000 PO 00000 Frm 00003 Fmt 0486 Sfmt 0486 S:\DOCS\30085.TXT SLABOR1 PsN: DENISE VerDate 0ct 09 2002 11:14 Apr 24, 2007 Jkt 000000 PO 00000 Frm 00004 Fmt 0486 Sfmt 0486 S:\DOCS\30085.TXT SLABOR1 PsN: DENISE NOMINATION OF ANDREW VON ESCHENBACH and PAUL DeCAMP TUESDAY, AUGUST 1, 2006 U.S. SENATE, COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, Washington, DC. The committee met, pursuant to notice, at 10 a.m., in room SD– 430, Dirksen Senate Office Building, Hon. Mike Enzi, chairman of the committee, presiding. Present: Senators Enzi, Alexander, Isakson, Ensign, Hatch, Ken- nedy, Dodd, Harkin, Mikulski, Murray, Reed and Clinton. Also present: Senator Hutchison. OPENING STATEMENT OF SENATOR ENZI The CHAIRMAN. Good morning, and welcome to the confirmation hearing for Dr. Andrew von Eschenbach, to be the Commissioner of the Food and Drug Administration and Mr. Paul DeCamp, to be the Wage and Hour Administrator of the Department of Labor. Both nominees are superbly qualified for these positions, and I look forward to their testimony and responses today. The FDA has a very broad and critical mission in protecting the public health. Dr. von Eschenbach, you’ll be in charge of an Agency that regulates $1 trillion worth of products a year. The FDA en- sures safety and effectiveness for all drugs and biological products, such as vaccines, medical devices, and animal drugs and feed. It also oversees the safety of a vast variety of food products, as well as medical and consumer products, including cosmetics. As Commissioner of the FDA, you’ll be responsible for advancing the public health by helping to speed innovations in its mission areas and by helping the public get accurate, science-based infor- mation on medicines and foods. As a physician, I know you take this mission to heart. I’m pleased that we are now ready to hear Dr. von Eschenbach’s plan to take charge, to take action, and to take responsibility for leading the FDA in the best interests of public health. We’ve met several times during your tenure as Acting Commissioner, and dis- cussed a variety of issues, including drug safety, advisory commit- tees, and citizen petitions. At those meetings, I’ve been impressed by your dedication to solving problems, and your focus on patient care, and your knowledge. One item we’ve discussed many times is the application to make the Plan B emergency contraceptive avail- able without a prescription. You made a major announcement (1) VerDate 0ct 09 2002 11:14 Apr 24, 2007 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\DOCS\30085.TXT SLABOR1 PsN: DENISE 2 about that yesterday, and I’m going to ask you to go over that in some detail later this morning. The FDA has been without a confirmed Commissioner for all but 18 months out of the last 51⁄2 years. I think we all can agree we need a strong leader at the FDA right now, and one who has a mandate to act. We must be forward-looking. There are many items before the FDA that require the immediate attention of an FDA Commissioner vested with full authority. But that authority flows directly from the act of Senate confirmation. Without a Senate-con- firmed leader, we can’t expect the FDA to be as effective as we need it to be. I urge my colleagues to consider this as we move for- ward. I look forward to working with you, Senator Kennedy, and with members of the committee, to protect and promote the public health and to maintain the FDA’s status as one of the world’s strongest regulatory agencies. We’ve been working in a very bipar- tisan way to get a bill that we think will do that. A confirmed com- missioner would be very helpful in that. Also
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