Supreme Court Cases
Historically, the FDA has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as FDCA legal cases that establish that the manager of a corporation can be prosecuted under the Federal FDCA, even if there is no affirmation of wrong-doing of the corporation manager individually.
In the Dotterweich case, the jury found Dotterweich, the president and general manager of a drug repackaging company, guilty on two counts for shipping misbranded drugs in interstate commerce, and a third for shipping an adulterated drug. One dissenting judge of the Circuit Court of Appeals reversed the decision on the grounds that only the corporation was the “person” subject to prosecution, thus protecting the president personally. But the Supreme Court reversed the decision thus holding Dotterweich individually responsible, not just the manufacturer. Justice Frankfurter delivered the opinion of the Court, “... under § 301 a corporation may commit an offense and all persons who aid and abet its commission are equally guilty….”
In the Park case, the chief executive officer was found guilty on all counts involving food held in a building accessible to rodents and being exposed to contamination by rodents, resulting in the adulteration of the food within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA). Park’s defense was that he had an organizational structure responsible for certain functions to handle such matters. However, evidence from inspections of multiple locations indicated the same problems and inadequate system for which he had overall responsibility. Chief Justice Burger delivered the opinion of the Court, “... by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so... the imposition of this duty, and the scope of the duty, provide the measure of culpability...”
FDASIA
More recently, Public Law 112-144 (July 9, 2012) called the Food and Drug Administration Safety and Innovation Act (FDASIA) added to the definition of CGMP in the Food and Drug Cosmetic Act (Section 501, 21 U.S.C. 351) to explicitly include management oversight of manufacturing to ensure quality. Section 711 of FDASIA states:
- For the purpose of paragraph (a)(2)(B), the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacturing of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.
The addition of oversight and controls to the definition of CGMP has strengthened the FDA position with specific language for management’s responsibility for oversight and control as a requirement in the Act. The question remains how to practically and operationally to perform this responsibility. The following model describes essential elements of a CGMP Management System for oversight and control.
Management System
The implication of the impact of CGMP noncompliance on the business is not theoretical. There are ample examples in the pharmaceutical industry where ineffective implementation of CGMP systems resulted in the loss of control that materially affected product quality, which, in turn, affected inventory and patient supply. Establishing a Pharmaceutical Quality System (PQS) that effectively implements the CGMPs is the means for maintaining a state of control—the fundamental intent of these regulations.
Management does not assume positions of responsibility with the intent of neglecting CGMP compliance. However, management may not enter the top position fully equipped to assume responsibility for CGMPs in a practical way. Management may delegate all CGMP matters to the Quality Department and take a hands-off approach and rely on this function to bring matters to its attention at their discretion. Such passivity leads to hearing only the bad news when it is far too late to contain and resolve the problem in the most cost-effective way with least risk to public safety.
Likewise, some Quality Departments may not be adequately equipped to bridge the space between top management and daily operations with effective structures and processes that enable management to exercise its responsibility for CGMP oversight. Too often the default position is to rely upon the outcome of regulatory inspections. But as one might expect, a good outcome can give a false sense of security, and a poor outcome can be viewed as the exhaustive list of problems. As in any area of the business where risks must be managed, there is no better approach than having an intentional management system in place that provides actionable data to know internally where your daily operation stands at any given moment.
Assess, Improve, and Implement--and Perform
For nearly 20 years, John Snyder and Company has served the pharma industry to assess, improve, and implement the Pharmaceutical Quality System (PQS). Our Management Triad Model will help you to assess and develop the crucial structures, systems, and processes for Management Oversight and Control for monitoring your state-of-control and to become an anticipating organization.
Please contact me at john@john-snyder.com. I want to partner with you.
The QA Pharm
