Regulatory Enforcement & Response
Adverse regulatory enforcement actions can cost FDA-regulated and life science companies millions to hundreds of millions of dollars. There are many theories on how to approach the development of FDA responses; however, one thing is clear: if you do not possess both a deep understanding of the enforcement process, and a practical, nuanced understanding of FDA’s requirements and expectations, your responses will miss their mark!
Further, enforcement responses are potentially only the beginning of a long, protracted negotiation with FDA regarding their view of operational changes that need to be implemented by your company. In order to negotiate with FDA and achieve the best outcomes, you need deeply experienced Counsel — that knows not only the law — but that understands the technical and operational context of the enforcement, and can distill response and remediation strategies and approaches from complex and difficult subject matter.
Jack Garvey has over 30 years of experience working in FDA-regulated industry. In both legal and non-legal roles, Jack’s background in chemical engineering combined with his deep understanding of applied Food and Drug law enables Jack to support companies in enforcement difficulties with a unique approach.
The Garvey Law Firm can provide the following services and support to FDA-regulated companies undergoing regulatory enforcement actions:
- FDA 483 Response Development & Remediation Plan Reviews
- Warning Letter Response Development & Remediation Plan Reviews
- Review of operational compliance under privilege, preserving confidentiality and supporting controlled remediation outcomes
- FDA mediation — negotiation and mediation of compliance deficiencies to achieve better enforcement resolution outcomes
- Consent Decree negotiation and support