McNeil Healthcare, Puerto Rico: FDA Case Study

FOOD AND DRUG ADMINISTRATION CASE STUDY The U.S. Food and Drug Administration (FDA) is the principal regulatory agency for the U.S. bio-pharmaceutical (BP) industry. In that role, it provides guidance, supervision and oversight. Together with the BP industry, the FDA has the task of ensuring that its products are safe, effective, and manufactured in accordance with "cGMP," the current Good Manufacturing Practice (U.S. Food and Drug Administration [FDA], 2004a). This paper is a case study of McNeil Consumer Healthcare and one of its main manufacturing facilities at Las Piedras, Puerto Rico. During this 12-year period, 2000 to 2011, the FDA determined that this manufacturing facility had significant out of compliance problems. These findings are highlighted in plant inspection reports, Form 483 observational reports, and warning letters (WLs) as well as product recalls, and a court ordered consent decree. This material offers a valuable window on FDA activities and performance over a 12-year period at this site. Using data from this in-depth case study provides a first step in understanding FDA performance in terms of compliance, oversight, and governance (FDA, 2004a). To determine whether the initial findings fit into a larger pattern of FDA practices, the results were then compared with other research that focuses on FDA performance using sector-wide data. The two principal academic investigations of the FDA's quality assurance (QA) that we are aware of are Adis' risk studies (2007; 2008) of the BP industry, and Marcher and Nickerson's (2006) review of quality systems. Both were sector evaluations, rather than a case study. Adis has also done some work with BP case studies (Adis, 2011). The McNeil Las Piedras facility is noteworthy in that it posed significant compliance challenges to the FDA during the 12-year period. That facility, as well as the Ft. Washington manufacturing site, was subject to several FDA Field Alerts concerning failed manufacturing processes and several large-scale recalls of such popular product as Tylenol, Motrin, and Listerine. McNeil's ongoing violations and the magnitude of the drug recalls have forced the FDA to post the 12-year history of inspections and out of compliance reports. With these reports, one can track and review FDA oversight and plant compliance (EIR, 2008). For the researcher, this opens the door to the site inspection process, and therefore quality assurance and risk prevention activities at Las Piedras. In addition, there are other public documents available: a judicial consent decree to mandate external monitoring, congressional transcripts of the FDA testimony concerning McNeil's recalls, and public statements from McNeil's management and their parent company Johnson and Johnson. Together, these documents fill in the narrative of activities during this timeframe of large-scale pharmaceutical recalls. The FDA's supervisory agency, the Center for Drug Evaluation Research (CDER), is directly responsible for the Finished Pharmaceuticals sector, which includes over -the-counter drugs (U.S. Food and Drug Administration, Center for Drug Evaluation Research [CDER], 2007). It is a large agency with approximately 960 FTE field employees and an annual budget approximately $195 million. It performs hundreds of inspections and enforcement activities per year, just in the area of over the counter drugs. Consequently, this review of McNeil Las Piedras is in fact a very narrow investigation into CDER' s quality assurance activities, presenting some initial evidence about CDER performance and its use of quality assurance techniques. To supplement these findings, the research then looked at CDER's activities and performance at inspection sites throughout the BP sector. BACKGROUND: MCNEIL CONSUMER HEALTHCARE McNeil, a subsidiary of Johnson and Johnson, had annual sales of U.S. $2.1 billion and 2600 employees in 2004. …