{"id":546931,"date":"2010-04-29T09:59:46","date_gmt":"2010-04-29T13:59:46","guid":{"rendered":"http:\/\/news.harvard.edu\/gazette\/?p=44599"},"modified":"2010-04-29T09:59:46","modified_gmt":"2010-04-29T13:59:46","slug":"peering-into-gearworks-of-fda","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/546931","title":{"rendered":"Peering into gearworks of FDA"},"content":{"rendered":"

Topping off at 800 pages, \u201cReputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA<\/a>\u201d is Daniel Carpenter<\/a>\u2019s opus.<\/p>\n

Carpenter, the Allie S. Freed Professor of Government and director of the Center for American Political Studies<\/a>, became fascinated with the Food and Drug Administration<\/a> (FDA)\u00a020 years ago \u201cbecause the agency was always in the news and because its decisions were so controversial at the same time that the agency was so highly respected in scientific and popular circles.\u201d<\/p>\n

But Carpenter said the research on the FDA then was \u201cincredibly simplistic. In these works, the FDA is either great or it\u2019s horrible; it\u2019s either purely altruistic or it\u2019s power-hungry. A number of well-informed scholars and careful observers of the agency told me the same thing: namely, that previous treatments had oversimplified the agency. I wanted to step outside of those binary narratives.\u201d<\/p>\n

One of his approaches was examining the FDA\u2019s reputation. \u201cA big part of the FDA\u2019s power comes from the way it is viewed by different audiences,\u201d said Carpenter. \u201cSo I spent a lot of time not only in the records and archives of the FDA, but in the records of medical associations and researchers, drug companies, research hospitals like Mayo Clinic and M.D. Anderson, European and Indian drug regulators and health agencies, politicians, and Supreme Court justices, social movement organizations, and interest groups.\u201d<\/p>\n

Behind the scenes, much of what happens at \u201cresearch universities around the world is dependent upon FDA rules, regulations, and discussions,\u201d said Carpenter.<\/p>\n

But what about the American people? Have they become disillusioned by dodgy pharmaceuticals and lawsuits?<\/p>\n

\u201cFor the audience of the mass public, the FDA\u2019s reputation is compelling because people believe that the agency has kept them safe, and that the FDA generally \u2018gets it right,\u2019\u201d he noted.<\/p>\n

\u201cThe most vivid event in building this reputation was FDA officer Frances Kelsey\u2019s\u00a0refusal to let thalidomide on the U.S. market,\u201d he said. \u201cWhen that drug was marketed in Europe and Australia, thousands of children were born with irreversible birth defects, and there were uncounted stillbirths and abortions.\u201d (Kelsey\u2019s photo is on the cover of the book.)<\/p>\n

\u201cThe general public does, on the whole, trust the FDA, though not as much as it used to,\u201d said Carpenter, who believes the next five to 10 years will be critical for the agency.<\/p>\n

\u201cReputation and Power\u201d also chronicles pivotal FDA decisions, from the 1980s AIDS crisis to oral contraceptives, to chemotherapy, to phased trials and manufacturing.<\/p>\n

\u201cThis has been 12 years, over 100 archival collections, and three continents of research in the making,\u201d said Carpenter. \u201cI think my proudest moment came when Richard Merrill, a former FDA general counsel and the nation\u2019s top legal scholar on drug regulation \u2014 and a tough critic \u2014 told me that the book was the best treatment of new drug regulation he had ever seen. From someone who lived it and studied it for decades, that was a nice endorsement.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

Topping off at 800 pages, \u201cReputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA\u201d is Daniel Carpenter\u2019s opus. Carpenter, the Allie S. Freed Professor of Government and director of the Center for American Political Studies, became fascinated with the Food and Drug Administration (FDA)\u00a020 years ago \u201cbecause the agency was always in the […]<\/p>\n","protected":false},"author":4175,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-546931","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/546931","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/4175"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=546931"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/546931\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=546931"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=546931"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=546931"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}