Limitless Surveillance at the Fda: Pro- Tecting the Rights of Federal Whistle- Blowers

LIMITLESS SURVEILLANCE AT THE FDA: PRO- TECTING THE RIGHTS OF FEDERAL WHISTLE- BLOWERS HEARING BEFORE THE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS SECOND SESSION FEBRUARY 26, 2014 Serial No. 113–88 Printed for the use of the Committee on Oversight and Government Reform ( Available via the World Wide Web: http://www.fdsys.gov http://www.house.gov/reform U.S. GOVERNMENT PRINTING OFFICE 87–176 PDF WASHINGTON : 2014 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 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 C:\DOCS\87176.TXT APRIL COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM DARRELL E. ISSA, California, Chairman JOHN L. MICA, Florida ELIJAH E. CUMMINGS, Maryland, Ranking MICHAEL R. TURNER, Ohio Minority Member JOHN J. DUNCAN, JR., Tennessee CAROLYN B. MALONEY, New York PATRICK T. MCHENRY, North Carolina ELEANOR HOLMES NORTON, District of JIM JORDAN, Ohio Columbia JASON CHAFFETZ, Utah JOHN F. TIERNEY, Massachusetts TIM WALBERG, Michigan WM. LACY CLAY, Missouri JAMES LANKFORD, Oklahoma STEPHEN F. LYNCH, Massachusetts JUSTIN AMASH, Michigan JIM COOPER, Tennessee PAUL A. GOSAR, Arizona GERALD E. CONNOLLY, Virginia PATRICK MEEHAN, Pennsylvania JACKIE SPEIER, California SCOTT DESJARLAIS, Tennessee MATTHEW A. CARTWRIGHT, Pennsylvania TREY GOWDY, South Carolina TAMMY DUCKWORTH, Illinois BLAKE FARENTHOLD, Texas ROBIN L. KELLY, Illinois DOC HASTINGS, Washington DANNY K. DAVIS, Illinois CYNTHIA M. LUMMIS, Wyoming PETER WELCH, Vermont ROB WOODALL, Georgia TONY CARDENAS, California THOMAS MASSIE, Kentucky STEVEN A. HORSFORD, Nevada DOUG COLLINS, Georgia MICHELLE LUJAN GRISHAM, New Mexico MARK MEADOWS, North Carolina Vacancy KERRY L. BENTIVOLIO, Michigan RON DESANTIS, Florida LAWRENCE J. BRADY, Staff Director JOHN D. CUADERES, Deputy Staff Director STEPHEN CASTOR, General Counsel LINDA A. GOOD, Chief Clerk DAVID RAPALLO, Minority Staff Director (II) VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 C:\DOCS\87176.TXT APRIL C O N T E N T S Page Hearing held on February 26, 2014 ....................................................................... 1 WITNESSES The Hon. Charles E. Grassley, A U.S. Senator from the State of Iowa Oral Statement ................................................................................................. 9 Written Statement ............................................................................................ 13 Mr. Walter Harris, Chief Operating Officer and Acting Chief Information Officer, U.S. Food and Drug Administration, Accompanied by Jeffrey Shuren, M.D., Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration, and Ruth McKee, Associate Director for Management, Center for Devices and Radiologic Health, U.S. Food and Drug Administration Oral Statement ................................................................................................. 21 Written Statement ............................................................................................ 24 Ms. Angela Canterbury, Director of Public Safety, Project on Government Oversight APPENDIX HHS Office of IG Report, Submitted by Rep.Issa ................................................. 88 Joint Staff Report, Submitted by Rep. Issa ........................................................... 119 Letter to Rep. Cummings from Rep. Issa, Submitted by Rep. Issa ..................... 271 (III) VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 C:\DOCS\87176.TXT APRIL VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 C:\DOCS\87176.TXT APRIL LIMITLESS SURVEILLANCE AT THE FDA: PRO- TECTING THE RIGHTS OF FEDERAL WHIS- TLEBLOWERS Wednesday, February 26, 2014 HOUSE OF REPRESENTATIVES, COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM, WASHINGTON, D.C. The committee met, pursuant to call, at 10:00 a.m., in Room 2154, Rayburn House Office Building, Hon. Darrell E. Issa [chairman of the committee] presiding. Present: Representatives Issa, Mica, Turner, Duncan, Jordan, Walberg, Lankford, Amash, Farenthold, Woodall, Massie, Collins, Meadows, Bentivolio, Cummings, Maloney, Lynch, Connolly, Speier, Kelly, and Lujan Grisham. Staff Present: Alexia Armstrong, Legislative Assistant; Molly Boyl, Deputy General Counsel and Parliamentarian; Lawrence J. Brady, Staff Director; Ashley H. Callen, Deputy Chief Counsel for Investigations; Sharon Casey, Senior Assistant Clerk; John Cuaderes, Deputy Staff Director; Lamar Echols, Counsel; Adam P. Fromm, Director of Member Services and Committee Operations; Linda Good, Chief Clerk; Caroline Ingram, Professional Staff Mem- ber; Mark D. Marin, Deputy Staff Director for Oversight; Ashok M. Pinto, Chief Counsel, Investigations; Krista Boyd, Minority Deputy Director of Legislation/Counsel; Aryele Bradford, Minority Press Secretary; Jennifer Hoffman, Minority Communications Director; Elisa LaNier, Minority Director of Operations; Una Lee, Minority Counsel; Juan McCullum, Minority Clerk; and Dave Rapallo, Mi- nority Staff Director. Chairman ISSA. The committee will come to order. The Oversight Committee’s mission statement is that we exist to secure two fundamental principles: First, Americans have a right to know that the money Washington takes from them is well spent; and, second, Americans deserve an efficient, effective government that works for them. Our duty on the Oversight and Government Reform Committee is to protect these rights. Our solemn responsibility is to hold government accountable to taxpayers, because taxpayers have a right to know what they get from their government. It is our job to work tirelessly in partnership with citizen watch- dogs and whistleblowers to deliver the facts to the American people and bring genuine reform to the Federal bureaucracy. Before I deliver my opening statement, because we have Senator Grassley here, I am going to ask unanimous consent that the IG report released last night entitled Department of Health and (1) VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCS\87176.TXT APRIL 2 Human Services IG Report, ‘‘Review of the Food and Drug Admin- istration’s Computer Monitoring of Certain Employees in Its Center for Devices and Radiological Health’’ be placed in the record. With- out objection, so ordered. Additionally, I ask that the joint staff report entitled ‘‘Limitless Surveillance at the FDA: Protecting the Rights of Federal Whistle- blowers,’’ be placed in the record. Mr. CUMMINGS. Mr. Chairman? Chairman ISSA. Yes. Mr. CUMMINGS. I have no objections, but I just want to make sure it is clear that that is the staff report of the Republicans. Is that right? Chairman ISSA. It is a joint report of the House and Senate Re- publicans. Mr. CUMMINGS. House and Senate. So the Senate Democrats were not involved. In this report, the Senate Democrats—— Chairman ISSA. This report is a result of an investigation in which all your Democrats’ staff were in there, but we did not ask for or provide a long comment period to your people. You are entitled to place a minority staff report at your convenience. You have the same information. Mr. CUMMINGS. We will definitely do that. I just wanted to make it clear on the record. Chairman ISSA. Absolutely. Without objection, so ordered. They are both in the record. And I will place my entire opening statement in the record and be brief. Today’s hearing is about a questionable practice at the FDA, one that has been under investigation for over 2 years—or almost 2 years, July of 2012, by the Inspector General, one that we do not consider to be political in any way, shape, or form, or partisan in any way, shape, or form. We consider it to be questionable, if not despicable, that whistleblowers, a known whistleblower and others, appear to have been targeted for an investigation proactively monitoring, effectively a wiretap on their computers, in order to see if they could get the dirt on employees so that they could take action. The FDA justified this based on a leak to the New York Times. However, to the best of our investigation, rather than working ret- rospectively to see if they could discover who had in the past leaked, they began a practice of monitoring computers, one that captured all information, forwarded all information, including, at a minimum, correspondence as whistleblowers with three members of Congress’s staff, Senator Grassley’s, our staff, and Chris Van Hollen of Maryland. It does not matter whether it is one or all. It does not matter whether it is a Republican or a Democrat. This committee believes in whistleblowers, encourages whistleblowers, and particularly believes that communications with members of Congress, the other branch, Article 1, are, in fact, off limits to that kind of monitoring. It appears as though no protections were placed on that, but, rather, this was an attempt at ‘‘gotcha.’’ There may have been good reason to be concerned. An investigation into leaks may have been very justified. In this case, we are not questioning whether or not VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\87176.TXT APRIL 3 an investigation should have occurred, but, rather, the tactics and the lack of protection there. Today

Load more