GxP Lifeline Feature Article
As corporate corruption--with or without executive intent--increasingly comes to light within the life science sector the FDA is reciprocally given additional power to administrate punitive measures. The FDA's increased powers include the following:
The FDA's power is also supported by the U.S. Supreme Court which, via the Park Doctrine, ruled that upper management should accept the ultimate responsibility for FDC violations.
- Significant inspectional authority under the Federal Food, Drug, and Cosmetic Act and the ability to determine by its own judgment whether a life science executive exercises the control necessary for strict adherence to his or her company's quality policies;
- Authority to issue warning letters, seek civil, administrative or criminal actions against a company;
- Authority to seek the personal liability of executives.1
Take, for example, the punitive measures doled out to the Purdue Frederick Company: $634.5 million after the defendants pleaded guilty to the intentional misbranding and the illegal promotion of the company's OxyContin drug.2 As astounding as this fine is, it is absolutely intimidating (at least for executives) that a sizeable portion of this original fine ($34.5 million) was directly ascribed to the company's General Counsel, the Chief Medical Officer, and the Chief Executive Officer. These execs paid a high price for intentional deceit of the public. However, even those execs devoid of intent to deceive are not exempt from egregious fines and jail time. In fact, every life science executive should be aware that protecting himself or herself means gaining control of every aspect of quality and compliance within his or her jurisdiction.
The following defensive measures will help executives gain an increased ability to oversee all aspects of quality and compliance within their respective environments:
Defense #1: Select a Responsible Quality Management Representative
Executives need to be aware of their company's quality and compliance-related documentation and whether or not the documentation addresses all applicable FDA regulations. Executives must also ensure that all company policies and additional regulatory documents are comprehended and adhered to by employees. If these responsibilities are not met, any company becomes an FDA target and its executives nothing more than a bull's eye.
To ease the burden of documentation and training management, executives should select a responsible quality management representative who will, for all intents and purposes, act as a member of the executive team. This quality executive should ensure that all quality documentation and processes are inspection-ready at any time. To do so, he or she should also consider the use of technology enablers that can electronically streamline document control, training, and process management.
Defense #2: Quality Review
Medical device companies are required by the FDA's QSR to perform a quality management review. This review is also highly recommended for pharmaceutical, blood/biologics, and other life science companies. The review should occur at least annually (according to the FDA's interpretation of a QSR required quality review) and should include the following:
- The attendance of all upper management members;
- Discussion regarding product problems, post-market issues, CAPAs, adverse events, complaints or recalls;
- The implementation or verification of CAPAs and other action items.
Defense #3: Creating a Strong Quality Policy
If executives want their employees to "live by" their company's quality policies then those policies must be implemented from top to bottom. For example, the communication of quality policies should be clear, with policies being posted throughout the employees' respective work environments. In addition, quality policies should be included in every employee/quality manual and employees should be continuously assured that providing constructive criticism in regard to company policies is always acceptable.
Defense #4: Implementing Technology Enablers
Implementing technology enablers in life science environments is of extreme value because they enable control over high-level iterative processes and streamline tedious--and costly--administrative work. For example, technology enablers can streamline documentation and processes associated with regulatory procedures, leaving executives with more time, more information, more confidence and less opportunity for error, fines or worst of all--jail time.
References1. The FDA's power is also supported by the U.S. Supreme Court which, via the Park doctrine, ruled that upper management should accept the ultimate responsibility for FDC violations. In other words, executives are ultimately responsible for actions taken by any employee that goes against FDA standards and documented company policies and documents.
Marci Crane is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).