Pharmaceutical-Related Warning Letters and Letters of Violation Released by the FDA between 1997 and 2010: Were they affected by Changes in the Federal Administration?

Objectives: The US Food and Drug Administration (FDA) conducts enforcement activities to protect the public health by assuring the safety, effectiveness, and security of pharmaceuticals. These enforcement activities include warning letters and notice of violation letters to pharmaceutical companies. The objectives of this study were to assess the trends in the pharmaceutical-related warning letters released by the FDA headquarters during the period 1997-2010. The study also assessed differences in the average number and type of warning letters released during the Second Clinton administration, the two Bush administrations, and the first two years of the Obama administration. Data and Methods: Data for warning letters and letters of violation released by the FDA between 1997 and 2010 derived from the FDA webpage. Information about the FDA Division releasing the letter, date, company, and drug-related violation was collected from each letter in an Excel file. Letters were classified by federal administration in the study period. Descriptive statistics were performed for the analysis. Results: Between 1997 and 2010 the FDA headquarters released 1177 warning letters and notice of violation letters related to pharmaceuticals. The majority of the letters were released by the Division of Drug Marketing, Advertising and Communications (DDMAC) (819, 69.6% of the total), followed by the Division of Scientific Investigations (DSI) (111, 9.43%), and the Office of Compliance (OC) (105, 8.92%). The average number of letters varied depending on the federal administration. During the period 1997-2000 (2nd Clinton Administration) the average number of letters per year was 141.5±39.3, during the period 2001-2008 (Bush Administration) it was 48.7±16.8, and during 2009-2010 (first two years of the Obama administration) it was 110.5±6.4. The average number of letters released by DDMAC also varied by administration: Clinton (122.0±36.8), Bush (29.5±16.2) and Obama (47.5±6.4). Conclusions: Most warning letters and letters of violation were related to marketing and advertising activities of pharmaceutical companies. The number of letters was related to the federal administration. The number of warning letters was highest during the second Clinton administration, diminished significantly during the Bush administrations, and increased again during the first two years of the Obama administration. An assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.