FDA Compliance Issues and Due Diligence - Discussion from FDLI Enforcement Conference 2021

Enforcement & Compliance Issues and Their Impact on Due Diligence in Transactions Involving FDA-Regulated Companies and Products

John (“Jack”) C. Garvey, Managing Partner, Compliance Architects LLC
Michael A Swit, Sr. Corporate Counsel, Regulatory Affairs, Varian Medical Systems
Suzie L. Trigg, Partner, Haynes, and Boone LLP
Moderated by Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
With the increasing difficulties in internally generated product development, medical product companies of all sizes are increasingly looking for deals to augment product lines. Whether in the form of single products or whole companies, transactions can make or break your company's future. However, often lost is the critical need to ensure that regulatory, clinical, and quality considerations do not undermine the value or viability of a deal. This session will address the regulatory, clinical, or quality issues – including data integrity failings – that must be reviewed when purchasing an FDA-regulated product or company and how to address those concerns in the due diligence phase.

Chapters:
00:00:00 - Introduction and Panelist Introductions
00:06:41 - The Importance of Due Diligence in Mergers and Acquisitions
00:13:28 - The Complexity of Quality Compliance and Due Diligence
00:20:14 - Key Documents and Effective Due Diligence
00:27:18 - Avoiding Quick Conclusions and Setting Expectations in Due Diligence
00:34:25 - Due diligence considerations for a company acquisition
00:41:20 - Regulatory reviews for combination products
00:47:55 - Data Integrity and GCP Issues
00:54:42 - The Importance of Value and Focus Areas in Quality Compliance during COVID-19.