McNeil, Ft. Washington: FDA Case Study

FOOD AND DRUG ADMINISTRATION CASE STUDY The FDA is the supervisory agency that provides oversight and guidance to the bio-pharmaceutical (BP) industry. It safeguards the public by ensuring that BP products are safe, effective, and manufactured in accordance with current Good Manufacturing Practice (U. S. Food and Drug Administration, 2004a). This paper provides a case study of McNeil Consumer Healthcare and its main manufacturing facility at Ft. Washington, Pennsylvania, from 2000 to 2011. Over this 12-year period, the case study details FDA activities at this site. This includes plant inspections, Form 483 observational reports (483), and warning letters (WLs), as well as recalls and plant closures. While it would be premature to extrapolate from one case study to overall FDA performance, it is fair to say that certain insights can be gained concerning procedures, performance, oversight, and governance. Similarly, these findings about FDA performance provide an opportunity to review how its newly adopted risk methodology and quality assurance practices are incorporated into its oversight practices. To put this case study into appropriate perspective, the findings were compared with other research that focuses on more quantitative studies of FDA performance using sector-wide data. The two principal academic investigations of FDA and quality assurance (QA) that we are aware of are Adis' risk studies (2007; 2008), and Marcher and Nickerson's (2006) review of quality systems. Both were sector evaluations, rather than a case study. The McNeil Ft. Washington facility is noteworthy in that it posed significant compliance challenges to the FDA during the 12-year period. There were several FDA Field Alerts about failed manufacturing processes and several large scale recalls of such popular product as Motrin, Tylenol, and Listerine. The problems at this site have caused the FDA to take the unusual step of making available the Establishment Inspection Reports (EIRs) for this facility. With these reports, one can track FDA interactions with the Ft. Washington site and review FDA oversight and plant compliance (Betterchem, 2008). In other words, the researcher has an insider's picture of quality assurance and risk prevention activities at Ft. Washington. The FDA rarely makes EIRs available because it respects manufacturers' concerns about releasing proprietary and confidential information. In addition, part of its mandate is to provide guidance, so a non-adversarial environment is preferred. Therefore findings from EIR plant inspections are regularly withheld, even from the provisions of the Freedom of Information Act (U. S. Food and Drug Administration, 2008a). But in this instance, due to the seriousness of the infractions at the McNeil site, the FDA has released the 12-year history of inspections and oversight. Though this material has been heavily redacted to maintain confidentiality, it is still a valuable resource. Furthermore, due to the extent and flagrance of the violations, there are additional public documents: a consent Decree to close the Ft. Washington plant, transcripts of the FDA testimony at congressional hearings about McNeil's recalls, and public statements from McNeil's management and their parent company Johnson and Johnson. These were helpful in piecing together the activities of the principals, during this time period of 7 major recalls. The Center for Drug Evaluation Research (U. S. Food and Drug Administration, Center for Drug Evaluation and Research, 2007) is the FDA agency directly responsible for the Finished Pharmaceuticals sector that includes over-the-counter drugs. It has thousands of employees and performs hundreds of inspections per year. Consequently, this case study review can be only a very narrow investigation into its quality assurance activities. By reviewing the data in this case study, the research is establishing some anecdotal evidence about CDER performance and its use of quality assurance techniques. …