Daniel G Dauner1, Kim Nichols Dauner2, Annalisa L H Peterson3. 1. Social and Administrative Pharmacy Program, College of Pharmacy, University of Minnesota, USA. Electronic address: ddauner@d.umn.edu. 2. Department of Economics and Health Care Management, Labovitz School of Business and Economics, University of Minnesota Duluth, USA. Electronic address: kdauner@d.umn.edu. 3. Department of Economics and Health Care Management, Labovitz School of Business and Economics, University of Minnesota Duluth, USA. Electronic address: alhp@d.umn.edu.
Abstract
BACKGROUND: The 2007 reauthorization of the Prescription Drug User Fee Act empowered the Food and Drug Administration (FDA) to require and enforce postmarketing studies to monitor the safety of prescription drugs, an increasing number of which are approved under expedited development or review programs. However, compliance rates for postmarketing requirements are low, and the FDA has not exercised its enforcement authority, allowing the very safety concerns that prompted the expansion of its power to continue. Prior evaluations have found that the FDA lacks reliable, timely, and readily accessible data for tracking postmarket safety issues, and that it has failed to enforce the postmarket surveillance measures it requires of the pharmaceutical industry. OBJECTIVE: This study provides an updated evaluation of FDA oversight of postmarketing requirements and commitments and assesses whether there have been improvements since 2010. METHODS: This study utilized data from the FDA's annual Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. It evaluated studies opened in FY 2011-2014 and tracked their status through the FDA's FY 2018 report (data as of September 30, 2018), thereby allowing the pharmaceutical industry 4-7 years to complete a given PMR/PMC. Descriptive statistics were calculated, and differences in the status of postmarketing requirements and postmarketing commitments between FYs 2011-2014 and FY 2009-2010 were evaluated. RESULTS: During fiscal years 2011-2014, there was little difference in the FDA's oversight of postmarketing studies compared to fiscal years 2009-2010. While there were some year-to-year significant differences, the overall trend indicated no change. CONCLUSIONS: The FDA's oversight of postmarketing studies has not improved since 2010. This paper discusses implications for providers and patients who unduly assume the responsibility of postmarketing surveillance due to the lack of FDA oversight.
BACKGROUND: The 2007 reauthorization of the Prescription Drug User Fee Act empowered the Food and Drug Administration (FDA) to require and enforce postmarketing studies to monitor the safety of prescription drugs, an increasing number of which are approved under expedited development or review programs. However, compliance rates for postmarketing requirements are low, and the FDA has not exercised its enforcement authority, allowing the very safety concerns that prompted the expansion of its power to continue. Prior evaluations have found that the FDA lacks reliable, timely, and readily accessible data for tracking postmarket safety issues, and that it has failed to enforce the postmarket surveillance measures it requires of the pharmaceutical industry. OBJECTIVE: This study provides an updated evaluation of FDA oversight of postmarketing requirements and commitments and assesses whether there have been improvements since 2010. METHODS: This study utilized data from the FDA's annual Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. It evaluated studies opened in FY 2011-2014 and tracked their status through the FDA's FY 2018 report (data as of September 30, 2018), thereby allowing the pharmaceutical industry 4-7 years to complete a given PMR/PMC. Descriptive statistics were calculated, and differences in the status of postmarketing requirements and postmarketing commitments between FYs 2011-2014 and FY 2009-2010 were evaluated. RESULTS: During fiscal years 2011-2014, there was little difference in the FDA's oversight of postmarketing studies compared to fiscal years 2009-2010. While there were some year-to-year significant differences, the overall trend indicated no change. CONCLUSIONS: The FDA's oversight of postmarketing studies has not improved since 2010. This paper discusses implications for providers and patients who unduly assume the responsibility of postmarketing surveillance due to the lack of FDA oversight.
Authors: Osman Moneer; Beatrice L Brown; Jerry Avorn; Jonathan J Darrow; Mayookha Mitra-Majumdar; Krysten W Joyce; Murray Ross; Catherine Pham; Aaron S Kesselheim Journal: Drug Saf Date: 2022-02-19 Impact factor: 5.228