The struggle between science and policy: President Ronald Reagan and the FDA in the 1980s. (360G-Wellcome-080071_Z_06_Z)

The struggle between science and policy: President Ronald Reagan and the FDA in the 1980s I have begun the task of researching President Ronald Regan's regulatory reform initiatives pertaining to the Food and Drug Administration, specifically focusing on the Center for Drug Evaluation and Research (CDER), the branch of the FDA that oversees and governs prescription medications. I hope to expand the historiography pertaining to President Ronald Reagan by introducing a work of medical/regulatory history into the existent corpus of literature. My examination of the Food and Drug Administration, the principal regulator of countless prescription medications, was subject to the same widespread ideological change as numerous other U.S. governmental agencies. How is this relevant to the history of medicine? The Food and Drug Administration's mission statement holds that the agency is to protect the public health and to ensure Americans get the accurate, science-based information they need. The medications approved by the Office of Drug Safety, one part of the Center for Drug Evaluation and Research, prolong countless lives and in other cases cause harmful side effects. Assessing how this scientific process was impacted by Reagan's policies is of utmost importance for future American policy. Was the prescription drug approval process undermined? Did the FDA fall into disarray in the 1980s, due to budget tightening, personnel downsizing, program atrophy and scandal? Did the FDA promote sales over science, serving as a de facto subsidiary of the very industry it was supposed to oversee? Answers to these questions will serve both Reagan historians and medical historians. The significance of this task and my project is underscored by the fact that this is centennial year of the passage of the 1906 Pure Food and Drugs Act, which established federal authority and jurisdiction to regulate and control most aspects of the drug industry. Now is the time to create awareness of this neglected component of the Reagan historiography and to incorporate aspects of medical history into that historiography.