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Oral History Interview with Lawrence Bachorik Director Office of Communications 1978-2015

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Oral History Interview with Lawrence Bachorik Director Office of Communications 1978-2015 Oral History Interview with Lawrence Bachorik Director Office of Communications 1978-2015 FDA Oral History Program Final Edited Transcript July 18, 2016 Table of Contents Table of Contents ............................................................................................................................ 2 Oral History Abstract ...................................................................................................................... 3 Keywords ........................................................................................................................................ 3 Citation Instructions ........................................................................................................................ 3 Interviewer Biography .................................................................................................................... 4 FDA Oral History Program Mission Statement .............................................................................. 4 Statement on Editing Practices ....................................................................................................... 4 Index ............................................................................................................................................... 5 Interview Transcript ........................................................................................................................ 9 Curriculum Vitae ........................................................................................................................ 247 Deed of Gift ................................................................................................................................ 249 Lawrence Bachorik Oral History 2 Lawrence Bachorik, c. 2013 Oral History Abstract Lawrence Bachorik came to FDA in the fall of 1978, as a speechwriter in the Office of the Commissioner. Over the next three and half decades he played an instrumental role in developing and administering FDA communications and media relations, writing speeches for Commissioners Donald Kennedy, David Kessler, and Jane Henney, and starting FDA’s Office of Public Affairs (now the Office of External Affairs). Keywords public affairs; media; public information; speechwriting; communications; stakeholders Citation Instructions This interview should be cited as follows: “Lawrence Bachorik Oral History Interview,” History Office, U.S. Food and Drug Administration, Department of Health and Human Services, July 18, 2016. Lawrence Bachorik Oral History 3 Interviewer Biography Catherine Copp, J.D. is former Associate Counsel for Foods and Policy Advisor in FDA’s Center for Food Safety and Applied Nutrition. Prior to her work in CFSAN, Catherine served in FDA’s Office of General Counsel for over fifteen years. She retired after thirty years at FDA, and joined the FDA History Office as an oral historian. She earned her law degree from the University of Michigan. Suzanne Junod, Ph.D. is an historian in the FDA History Office at the U.S. Food and Drug Administration. Soon after beginning her career at FDA in 1984, Suzanne helped to organize the FDA History Office. She is a subject matter expert in FDA history and her scholarly writings have been published in the Food, Drug, and Cosmetic Law Journal, the Journal of Federal History, and the Journal of the History of Medicine and Allied Sciences, as well as edited compilations. She earned her Ph.D. at Emory University in Atlanta, where she studied under James Harvey Young. FDA Oral History Program Mission Statement The principal goal of FDA’s OHP is to supplement the textual record of the Agency’s history to create a multi-dimensional record of the Agency’s actions, policies, challenges, successes, and workplace culture. The OHP exists to preserve institutional memory, to facilitate scholarly and journalistic research, and to promote public awareness of the history of the FDA. Interview transcripts are made available for public research via the FDA website, and transcripts as well as audio recordings of the interviews are deposited in the archives of the National Library of Medicine. The collection includes interviews with former FDA employees, as well as members of industry, the academy and the legal and health professions with expertise in the history of food, drug and cosmetic law, policy, commerce and culture. These oral histories offer valuable first-person perspectives on the Agency’s work and culture, and contribute otherwise undocumented information to the historical record. Statement on Editing Practices It is the policy of the FDA Oral History Program to edit transcripts as little as possible, to ensure that they reflect the interviewee’s comments as accurately as possible. Minimal editing is employed to clarify mis-starts, mistakenly conveyed inaccurate information, archaic language, and insufficiently explained subject matter. FDA historians edit interview transcripts for copy and content errors. The interviewee is given the opportunity to review the transcript and suggest revisions to clarify or expand on interview comment, as well as to protect their privacy, sensitive investigative techniques, confidential agency information, or trade secrets. Lawrence Bachorik Oral History 4 Index abortifascients Codex Alimentarius, 217 mifepristone (RU-486), 170 congressional affairs abortifscients Barton, Joseph, 133 mifepristone (RU-486), 177 leadership, 182 aspirin, 50, 52, 53 testimony, 103, 106, 133 Benson, James (Jim), 33, 62, 63, 71 Corey, Beverly. See Blackwell, Michael, 129 Cox, Virginia, 226 bovine spongiform encephalopathy (BSE), Crawford, Lester, 181, 209, 211 124, 125, 127 Crout, Richard (Dick), 28 Brand, Daniel, 40 Deighton, Gerry, 102 buildings Department of Health and Human Services Parklawn Building, 21, 26, 28, 56, 72, 79, relationship with FDA, 229 142, 143, 145, 151, 165, 228 deregulation, 29, 45 cancer fraud impact on FDA work culture, 56 Burzynski, Stanislov, 139 President's Council on Regulatory Relief, Cannon, Hugh, 68 46 career dietary supplements, 112, 115 Assistant Commissioner for External Dietary Supplement Health and Education Relations, 220 Act (DSHEA), 113 Associate Commissioner for Public Dingell, John, 120 Affairs, 98, 168 District Directors Commissioner’s speechwriter, 54, 55, public affairs, 235 210, 219 editing congressional testimony, 49 food labeling regulations, 29, 31 director of public relations at Fairfax medical device regulations, 31 Hospital Association (Inova Health education, 9 System), 57, 243 Ph.D. in 18th Century British literature, director of speechwriters, Office of Public 10 Affairs, 61 Edwards Committee, 69 George Mason University, 14 Edwards, Charles (Charlie), 69 George Washington University, 13 European Medicines Evaluation Agency Georgetown University, 12 (EMEA), 212 Office of Public Affairs, 54 external communications policy analyst, 47 digital communications, 98 recruitment to FDA, 15 FDA Consumer Updates, 222 return to FDA, 60 FDA Voice blog, 226 speechwriter, 39 external communications (media affairs), 90, training specialist, 38 92, 94, 95, 100, 123, 132, 141, 142, 162 writer/editor, Office of Policy interview clearance process, 215, 216 Coordination, 16, 20, 24 external communications (public affairs) centralization press releases, 194 human resources, 190 rollouts, 210 Chesemore, Ronald, 80 Talk Papers, 194 Chief Counsel, 203 Fairfax Hospital Association/INOVA Lawrence Bachorik Oral History 5 communications, 58 newsletter, 224, 225, 226 Feigal, David, 136 internal/external communications Flieger, Ken, 45 Commissioner's correspondence, 19, 23, Food and Drug Administration 27, 35 Modernization Act (FDAMA), 145 complex subject matter, 34 Food and Drug Law Institute (FDLI) annual Operation SHAKESPEARE, 24, 25, 26, meeting 27, 28, 29, 31 FDA Commissioner speeches, 70, 73, 74, plain language, 21, 22, 29 106, 107, 110 style guide, 25 food contamination training, 27, 28 Odwalla juice, 130, 148, 150, 151 international affairs, 213 food labeling, 66, 116, 117 imports, 174 fresh, 85, 88 investigational new drug (IND), 50 Freedom of Information (FOI) requests, 101, Kennedy, Donald, 14, 18, 19, 21, 22, 23, 24, 102 25, 26, 27, 29, 32, 35, 36, 43, 48, 49, 51, Friedman, Michael, 144, 145, 146, 161, 162, 78, 185 164, 165 notoriety, 78 generic drug scandal, 64, 65 Kessler, David, 47, 49, 63, 67, 68, 69, 70, Gladwell, Malcolm, 64 72, 73, 74, 76, 77, 80, 82, 84, 85, 86, 87, Gottlieb, Scott, 218 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, Goyan, Jere, 27, 35, 36, 37, 179 100, 103, 104, 106, 108, 109, 110, 111, Grumbly, Thomas, 14 112, 113, 114, 115, 116, 117, 118, 120, Halperin, Jerry, 28 126, 130, 131, 132, 133, 134, 139, 140, Hamburg, Margaret (Peggy), 222 141, 144, 145, 146, 148, 149, 150, 151, Hayes, Arthur, 37, 39, 44, 46, 54, 107 152, 153, 158, 159, 160, 161, 162, 164, headquarters-field relations, 82, 228, 229, 167, 172, 173, 175, 199, 245 234, 235 leadership, 154, 157, 158 Henney, Jane, 102, 109, 112, 144, 160, 161, notoriety, 78, 79 163, 164, 165, 166, 167, 168, 169, 170, scholarly publications, 159 171, 172, 176, 177, 178, 179, 180, 181, work ethic, 154 182, 183, 185, 186 Kubic, Milan (Mike), 62 hiring, 199 Larkin, Timothy, 36, 37 HIV/AIDS, 80, 108, 110 Levitt, Joseph (Joe), 60, 62 ACTUP protest, 79 L-tryptophan, 112 blood supply safety, 119, 120, 121 Lumpkin, Mac, 218 Hubbard, William (Bill), 59, 60 Martin, Jack, 68 human tissue safety, 207 Martino, Elizabeth (Beth), 224 information technology McClellan, Mark, 109, 182, 192, 193, 194, Wang word
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