1. See D.P. Carpenter , “Adaptive Signal Processing, Hierarchy, and Budgetary Control in Federal Regulation,”American Political Science Review(June 1996 ): 283 –302.
2. R. Widmark , “Memo regarding Hepatotoxicity of Bromfenac,” undated [December 1995], 3, NDA File 20-535, FDA CDER. See also “Wyeth-Ayerst Duract Hepatotoxicity Warning Was Suggested during NDA Review,”Pharmaceutical Approvals Monthly, F-D-C Reports (April 1998 ): 34 .
3. This is not necessarily the case. If the hazards of drug products are easily discerned and newsworthy, then the assumption is safe. But solid knowledge about product hazards often emerges only many years after market entry and is disseminated more in academic discussions than in the popular news media (the thousands of lost lives attributable to malprescription of arrhythmia drugs such as Tambocor and Encaid). See Hilts ,Protecting America’s Health, 231 –232
4. TheWashington Postand the Vanderbilt TV News database both have electronically searchable archives. For the methodology used to aggregate stories, see D.P. Carpenter , “Groups, the Media, Agency Waiting Costs, and FDA Drug Approval,”American Journal of Political Science(July 2002 ): 490 –505.
5. R.A. Merrill , “Modernizing the FDA: An Incremental Revolution,”Health Affairs(Mar/Apr 1999 ): 96 –111.