Tag Archives: FDA

John D. Graham

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Collection: Perspectives on Modern Regulatory Governance
Dates of interview: March 2, 2016 and April 21, 2016
Interviewer: Ashton Merck, Edward Balleisen (Jonathan Wiener – first interview only)
Interview length: Two sessions of approximately two hours each
Transcript: (PDF)
Location of interview: Kenan Institute for Ethics, Duke University, Durham, NC

Brief biography: John D. Graham was the administrator of the Office of Information and Regulatory Affairs (OIRA) from 2001-2006. Graham holds an M.A. in Public Affairs from Duke University and a B.A. from Wake Forest University, and received his Ph.D. in Urban and Public Affairs from Carnegie Mellon University. Graham is a leading scholar in the field of risk analysis and cost-benefit analysis, authoring or co-authoring 10 books and over 200 articles. Graham founded the Harvard Center for Risk Analysis in 1989 and directed it until he left for OIRA in 2001. After leaving OIRA, Graham became an academic administrator; Graham is currently the Dean of the School for Public and Environmental Affairs at Indiana University.

Brief summary: The first interview provides an overview of Graham’s early life and professional trajectory as an academic, concluding with his nomination for the position of OIRA Administrator, and describing the experience of the Senate confirmation process. The second interview discusses Graham’s tenure as OIRA administrator, including several significant changes to OIRA’s policies and practices, as well as the substance of several key regulations that were subjected to OIRA review during Graham’s term in office. The interview includes a discussion of Graham’s career since completing his service in government, and some reflections on the past and future of regulatory review.

Time range of discussion: 1978-2015

Agencies mentioned:
Office of Management and Budget
Office of Information and Regulatory Affairs
Council on Competitiveness
Council on Wage and Price Stability
Occupational Safety and Health Administration
Environmental Protection Agency
National Transportation and Highway Safety Administration
Office of Science and Technology Policy

Institutions mentioned:
Brookings Institution
Center for Science and the Public Interest
Harvard University Kennedy School of Government
Harvard Center for Risk Analysis
Harvard School of Public Health
ILSI International Life Sciences Institute
Indiana University School of Public and Environmental Affairs
Mercatus Center
National Academy of Sciences
National Science Foundation
Office of Economic Cooperation and Development
Pardee RAND School
Resources for the Future
Union of Concerned Scientists

Firms mentioned:
BASF/Bayer, Cummins Engine, DuPont, Dow Chemical, Rohm and Haas, Shell

Legislation, rules, and judicial rulings mentioned:
Circular A-4
Information Quality Act
REACH (EU)
Sarbanes-Oxley Act
Industrial Union Department, AFL-CIO v. American Petroleum Institute, et al. 448 U.S. 607 (1980) (the “benzene decision”)
Motor Vehicle Manufacturers Association of the United States, Inc., et al. v. State Farm Automobile Insurance Company et al., 463 U.S. 29 (1983)

Locations mentioned:
Carnegie Mellon University
Duke University
Harvard University
Washington, D.C.

Regulatory concepts discussed:
cost-benefit analysis
impact assessment
prompt letter
return letter
risk assessment

People mentioned:
Nancy Beck
Eula Bingham
James Blumstein
Joshua Bolten
Stephen Breyer
James S. Coleman
Susan Collins
Robert W. Crandall
Mitch Daniels
Tom Daschle
Bob Dole
Dick Durbin
Christopher Edley, Jr.
John Evans
Harvey Fineberg
Arthur Finkelstein
Steven Garber
Newt Gingrich
Wendy Gramm
Laura Green
Thomas Grumbly
Patricia Gwaltney (McGinnis)
Jim Hammond
Dennis Hastert
Jeff Holmstead
Al Hubbard
Bennett Johnston
Sally Katzen
Lester Lave
Carl Levin
Joseph Lieberman
Charles Lindblom
Trent Lott
Granger Morgan
Daniel Patrick Moynihan
Paul Noe
Howard Raiffa
William Reilly
William Ruckelshaus
Eileen Serene
Olympia Snowe
Cass Sunstein
Kimberly Thompson
Fred Thompson
James Vaupel
Arnold Weber
Milt Weinstein
Christie Todd Whitman
Jonathan Wiener

Selected bibliography for additional background:

  • Graham, John D., and James W. Vaupel. “The Value of a Life: What Difference Does It Make?” In Risk/Benefit Analysis in Water Resources Planning and Management, 233–43. Springer US, 1981.
  • Graham, John D., and Patricia Gorham. “NHTSA and Passive Restraints: A Case of Arbitrary and Capricious Deregulation.” Administrative Law Review, 1983, 193–252.
  • Tengs, Tammy O., Miriam E. Adams, Joseph S. Pliskin, Dana Gelb Safran, Joanna E. Siegel, Milton C. Weinstein, and John D. Graham. “Five-Hundred Life-Saving Interventions and Their Cost-Effectiveness.” Risk Analysis 15, no. 3 (1995): 369–90.
  • Graham, John D. “The Perils of the Precautionary Principle: Lessons from the American and European Experience.” Vol. 818. Heritage Foundation, 2004.
  • Graham, John D., Paul R. Noe, and Elizabeth L. Branch. “Managing the Regulatory State: The Experience of the Bush Administration.” Fordham Urban Law Journal 33 (2005): 953.
  • Bagley, Nicholas, and Richard L. Revesz. “Centralized Oversight of the Regulatory State.” Columbia Law Review 106, no. 6 (2006): 1260–1329.
  • Graham, John D. “Saving Lives through Administrative Law and Economics.” University of Pennsylvania Law Review, 2008, 395–540.
  • Wiener, Jonathan Baert, and John D. Graham. Risk vs. Risk: Tradeoffs in Protecting Health and the Environment. Harvard University Press, 2009.

Select newspaper articles

  • Stephen Power, Jacob M. “Redrawing the Lines: Bush’s Rules Czar Brings Long Knife to New Regulations — `Smart’ Style Helps to Disarm Critics while Developing Business-Friendly Agenda — Outdoing EPA on Emissions.” Wall Street Journal, Jun 12, 2002, Eastern edition.
  • Cindy Skrzycki, “Nominee’s Business Ties Criticized,” The Washington Post, May 15, 2001, E01.
  • “Graham’s Cracker.” Wall Street Journal, Jun 27, 2001, Eastern edition.
  • Ellen Nakashima, “Influence of Industry on Rules Agency Questioned,” The Washington Post, March 13, 2002, A27.
  • Ellen Nakashima, “For Bush’s Regulatory ‘Czar,’ The Equation Is Persuasion; Graham Wields Cost-Benefit Analysis For, Against Rules,” The Washington Post, May 10, 2002, 35.
  • ———. “Regulations Face Stiffer Review in Win for Bush Business Allies.” Wall Street Journal, Aug 29, 2003, Eastern edition.
  • Judith Weinraub, “The Hidden Fat; Some scientists have known about the dangers of trans fats for more than two decades. What took the government so long?” The Washington Post, September 10, 2003, F01.
  • McKinnon, John D. “How U.S. Rules are made is Still a Murky Process.” Wall Street Journal, Oct 22, 2003, Eastern edition.
  • Alex Fryer, “Bush administration’s gatekeeper weighs costs, benefits of new regulations.” Seattle Times, September 29, 2004.
  • Cindy Skrzycki, “Report Sheds Light on Changing Role of Regulation,” The Washington Post, January 25, 2005, E01.
  • Rick Weiss, “’Data Quality’ Law Is Nemesis Of Regulation,” The Washington Post, August 16, 2004, A1.
  • Cindy Skrzycki, “Looking Back on the Presidents’ Policy Wonks,” The Washington Post, November 1, 2005, D01.

Lyndon Johnson Library

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The Lyndon Johnson library website hosts numerous fully transcribed and searchable oral history interviews. Topics span Johnson’s full political career, including his time in the House and Senate, as vice president to John Kennedy and as president. Some interviewees themselves had long political careers as civil servants and elected officials. Therefore, researchers interested in regulatory politics of the entire post-war period should search the LBJ library for relevant content.

Unlike some other presidential library oral history projects (see for example the summary of the Carter library), regulation is not a focal point of the LBJ library interviews. Consequently, relevant discussions are scattered throughout the interviews and are often only incidental to any given interview’s general themes.

Nevertheless, some themes of interest do emerge. Interviews that focus on LBJ’s Congressional career include topics pertaining to energy policy and the challenges and opportunities these posed for Johnson as a delegate from Texas. Oil and gas regulation, particularly pertaining to the 1956 “Bill to Amend the Natural Gas Act,” receive attention for its importance of LBJ’s career trajectory and establishment of his position as a national figure. Great Society and Civil Rights legislation, hallmarks of the LBJ administration, also contained regulatory provisions. The follow is a partial list, roughly in descending order of prevalence, of regulatory topics addressed in the transcribed and searchable LBJ library interviews.

  • Oil and Natural Gas (Texas Railroad Commission (in the context of energy policy))
  • Antitrust enforcement though the Justice Department (especially during the Kennedy administration)
  • Regulation of the outdoor advertising industry
  • Lobbying by interest groups and influence on regulatory policy making
  • Kennedy-era attempts to reorganize regulatory agencies
  • Route assignments by the Civil Aeronautics Board
  • Regulatory commission appointments
  • FDA response to the thalidomide tragedy
  • USPS regulations
  • Interviews pertaining to the institution of Medicare and Medicaid and certain provisions of the Civil Rights Act may also have content pertaining to regulation

This list is not exhaustive. It only reflects topics that emerged in an initial survey.  See suggested search strategies for ideas on how to more thoroughly explore this archive’s offerings.

Summary by:  Elizabeth Brake

Dwight Eisenhower Library

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The website of the Eisenhower Library in Abilene, Kansas, is an access portal for oral histories of the administration that are available through multiple institutions, primarily the Eisenhower Library, the Columbia University Oral History Project, as well as other libraries with smaller collections. The library website provides detailed abstracts of linked interviews, but in most cases researchers must visit the repositories to access transcripts for audio files. (A limited number of transcripts are available online.) The full list of interviews is available at the Eisenhower library’s oral history page.

An initial survey reveals nineteen interviews with abstracts or transcripts available through the Eisenhower library that contain significant content pertaining to regulatory issues. These interviews provide a window on the evolution of the post-war American regulatory state, with particular attention to global contexts, including the Cold War, the Korean war, the development of the European Common Market, and advancements in and proliferation of nuclear energy technologies and weapons. The Atomic Energy Commission, the Federal Reserve, and the agricultural commodities trade (esp. sugar) receive particular attention in these geopolitical contexts. Domestically, post-war economic growth fostered renewed political debate over the federal government’s role in the economy and the continued utility of regulatory policies first instituted during the New Deal. Several interviews discuss the establishment of the Federal Aviation Agency (precursor to the Federal Aviation Administration) and the growth of the airline industry. Changes to the policy structures for the regulation of agricultural commodities are also a prominent themes. Many interviews cover issues related to  U.S. fiscal and economic policies and regulations. Several discuss the activities and internal politics of the president’s Council of Economic Advisors. Others discuss appointments, staffing, and regulatory actions by the Securities and Exchange commission and enforcement of anti-trust policy by the Justice Department.

Summary by:  Elizabeth Brake

Food and Drug Administration Oral History Program

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Collection description: The FDA began its oral history program in the mid 1970s, interviewing staff members towards the end of their careers. Per the oral history program’s description, “Though the program’s early focus was on agency staff directly connected to enforcement work, the History Office today collects oral histories from staff at all levels and across the agency.” More detailed information on the program can be found here.

Regulatory significance: This is a rich collection that explores in great detail the regulatory process from frontline monitoring to higher level rule-making.

Dates: 1974 – present

Digital access: Partial and full transcripts of many of these interviews can be found on the FDA website.

Physical access: Tapes and transcripts of the oral histories are deposited in the History of Medicine Division of the National Library of Medicine, in Bethesda, Maryland.

Interviewees: ~150

Women in the Federal Government Project

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Project description: The purpose of the project was to interview selected women who held civil service or appointed positions and to make the interview transcripts available to students and researchers interested in tracing the careers and contributions of women in the federal government. The project, which includes nine oral histories, focuses on women who began their government careers during the first half of the twentieth century, and includes narrators from such varied fields as law, education, economics, business, engineering, and medicine. Related interviews may be available at the Arthur and Elizabeth Schlesinger Library on the History of Women in America, which helped fund the project.

Regulatory significance: A few of these interviews suggest regulatory significance. The oral history with Caroline Ware involves consumer protection and the Food and Drug Administration. Other interviewees discuss social security, Medicare, Medicaid, and regulation to address employment discrimination.

Repository: Columbia Center for Oral History

Interview dates: 1981-1988

Digital access: Only abstracts. No online transcripts or audio.

Physical access: For transcripts and audio, researchers may visit the Columbia Center for Oral History.

Link: http://oralhistoryportal.cul.columbia.edu/document.php?id=ldpd_4073685

Interviewees: Ida Craven Merriam, Margaret Joy Tibbetts, Mabel Deutrich, Katnerine Brownell Oettinger, Caroline Ware, Ellen Black Winston, Mildred McAfee Horton, and Mary Dublin Keyserling.

Pioneers of the Medical Device Industry in Minnesota

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Project description: This collection of 17 interviews focuses on the growth of the medical device industry in Minnesota.

Regulatory significance: Many of these interviews discuss regulation of the medical device industry by the U.S. Food and Drug Administration. Discussions also involve liability, non-U.S. regulation in Europe and South America, and the role of trade groups and state support for the industry.

Repository: Minnesota Historical Society

Interview dates: 1995-2001

Digital access: Transcripts, as well as audio, are available online.

Physical access: Original interview materials are available at the Minnesota Historical Society in St. Paul, Minnesota.

Link: http://collections.mnhs.org/voicesofmn/index.php/10002544