Data integrity continues to be one of the topmost concerns for regulators and enforcement authorities in the pharmaceuticals and medical devices space. In recent years, scrutiny surrounding data integrity has heightened due to the high number of violations found during routine inspections. Breaches of data integrity can have severe consequences, such as damaging press coverage; denial, suspension, or withdrawal of an application; product recalls; and civil and criminal liability that, in the United States, can extend to senior executives.
Sidley has extensive experience representing pharmaceutical and medical device companies in complex data integrity matters. We have conducted data integrity investigations on five continents and have represented our clients in matters before the Food and Drug Administration as well as the U.S. Department of Justice. We advise clients throughout the whole life cycle of their products, ensuring they have procedures and systems in place to meet regulatory expectations, as well as to identify and remediate systemic gaps that could permit intentional or unintentional breaches of data integrity. Our team provides a range of services to clients in the United States and abroad, including:
- Conducting internal investigations on data integrity issues and whistleblower complaints arising in the manufacturing, preclinical, and clinical contexts
- Representing clients in potential civil and criminal exposure in connection with data integrity issues and actions on data integrity issues
- Compliance counseling on FDA data integrity requirements
- Advising clients on the design, operation, and monitoring of systems and controls to maintain data integrity
- Preparing regulatory response strategies for FDA inspectional observations involving data integrity violations
- Supporting remediation of data integrity breaches, including development of corrective actions and notification of regulatory bodies
- Conducting periodic data assessments to identify potential gaps and ensure compliance with regulations
- Advising on best practices for data integrity in connection with preclinical research and clinical trials
- Conducting and reviewing internal training on data integrity principles and best practices
Representative engagements:
- Conducting numerous internal investigations for pharmaceutical companies in connection with data integrity issues at manufacturing and clinical sites in the United States, Europe, China, India, Japan, and worldwide
- Representing a global pharmaceutical company in an internal investigation and disclosure to FDA concerning alleged laboratory data integrity violations at a foreign manufacturing facility
- Successfully obtaining DOJ declination for a multinational pharmaceutical company in a criminal and civil data integrity and good manufacturing practices (GMP) investigation conducted by District of New Jersey
- Successfully obtaining DOJ declination for a multinational pharmaceutical company in a criminal and civil data integrity and GMP investigation conducted by Southern District of New York
- Advising a global pharmaceutical manufacturer on compliance with a Consent Decree involving data integrity and GMP obligations
- Performing data integrity assessments for clients in Asia, Europe, and the United States