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Next Steps Hearing Committee on Health, Education, Labor S. HRG. 109–111 BIODEFENSE: NEXT STEPS HEARING BEFORE THE SUBCOMMITTEE ON BIOTERRORISM AND PUBLIC HEALTH PREPAREDNESS OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED NINTH CONGRESS FIRST SESSION ON EXAMINING THE BIODEFENSE RESEARCH PROGRAM OF THE NATIONAL INSTITUTES OF HEALTH, FOCUSING ON THE DEVELOPMENT OF MED- ICAL COUNTERMEASURES AGAINST A BIOTERRORIST ATTACK FEBRUARY 8, 2005 Printed for the use of the Committee on Health, Education, Labor, and Pensions ( U.S. GOVERNMENT PRINTING OFFICE 98–930 PDF WASHINGTON : 2005 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 11-MAY-2000 10:12 Sep 09, 2005 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 98930.TXT SLABOR2 PsN: SLABOR2 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 SUBCOMMITTEE ON BIOTERRORISM AND PUBLIC HEALTH PREPAREDNESS RICHARD BURR, North Carolina, Chairman JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa MIKE DEWINE, Ohio BARBARA A. MIKULSKI, Maryland JOHN ENSIGN, Nevada JEFF BINGAMAN, New Mexico ORRIN G. HATCH, Utah PATTY MURRAY, Washington PAT ROBERTS, Kansas JACK REED, Rhode Island MICHAEL B. ENZI, Wyoming (ex officio) ROBERT KADLEC, M.D., Staff Director DAVID C. BOWEN, Minority Staff Director (II) VerDate 11-MAY-2000 10:12 Sep 09, 2005 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 98930.TXT SLABOR2 PsN: SLABOR2 CONTENTS STATEMENTS TUESDAY, FEBRUARY 8, 2005 Page Burr, Hon. Richard, Chairman, Subcommittee on Bioterrorism and Public Health Preparedness, opening statement .......................................................... 1 Kennedy, Hon. Edward M., a U.S. Senator from the State of Massachusetts, opening statement ................................................................................................ 3 Enzi, Hon. Michael B., Chairman, Commmittee on Health, Education, Labor, and Pensions, prepared statement ..................................................................... 4 Roberts, Hon. Pat, a U.S. Senator from the State of Kansas, prepared state- ment ...................................................................................................................... 6 Fauci, Anthony, M.D., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services; Penrose C. Albright, Ph.D., Assistant Secretary for Science and Technology, Department of Homeland Security ........................... 7 Prepared statements of: Anthony Fauci, M.D. ................................................................................. 10 Penrose C. Albright, Ph.D. ....................................................................... 22 Painter, George, Ph.D., CEO, Chimerix, INC.; Jon Abramson, M.D., Professor and Chair, Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, North Carolina; Gerald L. Epstein, Senior Fellow for Science and Security, Homeland Security Program, Center for Strategic and International Studies; Gordon Cameron, CEO, Acambis, PLC ................ 46 Prepared statements of: George Painter, Ph.D. ............................................................................... 49 Jon Abramson, M.D. .................................................................................. 54 Gerald L. Epstein ...................................................................................... 60 Gordon Cameron ....................................................................................... 70 ADDITIONAL MATERIAL Statements, articles, publications, letters, etc.: Summary of the President’s 2006 budget for Homeland Security ................ 31 Questions of Senator Roberts to Mr. Albright, Ph.D. .................................... 37 Questions of Senator Roberts to the panel ..................................................... 37 Questions of Senator Enzi to Mr. Albright, Ph.D. ......................................... 44 Generic Pharmaceutical Association ............................................................... 82 Randi Airola ...................................................................................................... 84 Meryl Nass, M.D. .............................................................................................. 87 The Military Vaccine Education Center ......................................................... 91 (III) VerDate 11-MAY-2000 10:12 Sep 09, 2005 Jkt 000000 PO 00000 Frm 00003 Fmt 0486 Sfmt 0486 98930.TXT SLABOR2 PsN: SLABOR2 VerDate 11-MAY-2000 10:12 Sep 09, 2005 Jkt 000000 PO 00000 Frm 00004 Fmt 0486 Sfmt 0486 98930.TXT SLABOR2 PsN: SLABOR2 BIODEFENSE: NEXT STEPS TUESDAY, FEBRUARY 8, 2005 U.S. SENATE, SUBCOMMITTEE ON BIOTERRORISM AND PUBLIC HEALTH PREPAREDNESS, COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, Washington, DC. The subcommittee met, pursuant to notice, at 10:05 a.m., in room SD–430, Dirksen Senate Office Building, Hon. Richard Burr, chair- man of the subcommittee, presiding. Present: Senators Burr, Roberts, Enzi [ex officio], Kennedy, Mur- ray and Reed. OPENING STATEMENT OF SENATOR BURR Senator BURR. I would ask that the subcommittee hearing come to order. I want to thank you for coming to the first hearing of the Health Subcommittee on Bioterrorism and Public Health Prepared- ness. I am looking forward to working with the chairman of the full committee, Senator Enzi, the ranking member, Senator Kennedy, and all the members of this subcommittee throughout this session of Congress. I think that we have the distinction of holding the first Health subcommittee hearing of the year, but I have always believed that when it comes to bioterrorism, you have to be ahead of the curve. Already the Senate has before it S. 3, the Bioterrorism Legislation, introduced by Senator Gregg. I know that Senator Hatch and Sen- ator Lieberman have also been working hard on a Bioshield II bill. Bioterrorism has been an important issue to me for some time. In fact, I sponsored the first bioterrorism legislation in the House before September 11. It was obvious to me the United States had a very real vulnerability to being held hostage to bioterror. After September 11, it became even more apparent that the threat was real and the government needed to work with industry to build up our protection and our ability to react to any type of an attack. As a freshman senator, I recognized that many senators before me have worked very hard on strengthening our Nation’s defense against bioterrorist attacks. I am humbled to have the opportunity to work with them and many of whom are members of this commit- tee and specifically this subcommittee. As I mentioned earlier, as a member of the House of Representa- tives, I sponsored the first bioterrorism legislation in the House, the Public Health Threats and Emergency Act of 2000. I was pleased to help create the Public Health Security and Bioterrorism (1) VerDate 11-MAY-2000 10:12 Sep 09, 2005 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 98930.TXT SLABOR2 PsN: SLABOR2 2 Preparedness Response Act of 2002, and followed that legislation up with the Smallpox Emergency Personnel Protection Act of 2003. This subcommittee has a lot of important work ahead of it. Last year, the Project Bioshield Act was signed into law, but many peo- ple believe that there is a need for subsequent legislation that will further strengthen the program’s viability. This year we will take up that discussion and legislative action on this important subject. Next year, unbelievably, it will be time to reauthorize the bio- terrorism legislation from 2002. The goal of today’s hearing is to examine implementation of Project Bioshield. I believe that Bio- shield has begun to address the bioterrorism threat but acknowl- edge that more is needed to fully protect our country. In order to increase critical scientific effort in the area of the bioterrorism pre- paredness, the government must have full participation in this work from the pharmaceutical and biologic industries. I hope that today’s witnesses will help us understand what we can do, what industry can do, to achieve the best working relation- ship that benefits the American people. Our first panel we have Dr. Tony Fauci, Director of the National Institute of Allergy and Infectious Diseases. Dr. Fauci is the lead scientist and director of the HHS effort on bioterrorism. We also have Penrose Albright, Assistant Secretary of Science and Technology Directorate at the Department of Homeland Secu- rity. Mr. Albright has been involved in the national security arena since 1986 and is directly involved in the implementation of Project Bioshield at the Department of Homeland Security. On our second
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