After a brief hiatus, DEA Chronicles is back. As always, I will be keeping you informed on changes in the relevant laws and regulations and how these may impact your business. But, as regular readers know, we go beyond simple reporting. DEA Chronicles identifies DEA enforcement trends. We engage in policy analysis across the spectrum of issues involving controlled substances. What regulatory approaches best combine an effective strategy for combating diversion with a workable framework for the various actors in the pharmaceutical industry? What are the best practices designed to ensure compliance? What are the red flags that should alert companies to potential problems within their organizations? We explore these and all other questions regarding the enforcement of controlled substance laws and regulations.
So why the hiatus? The answer is simple and, for me at least, kind of exciting. After six and a half years with Quarles & Brady, I am pleased to announce that I have moved the DEA Litigation and Compliance practice to my new firm, Cote Law PLLC. I bring to my DEA practice a unique set of experience and skills. For one, I worked at DEA at a management level in the enforcement area. I know my way around the agency. I know how it operates and how it thinks. It is one thing to read a statute or a regulation. It is another to understand how the people at the agency approach the enforcement of these laws.
My experience at DEA taught me something else. DEA has an important job to do. This is helpful to keep in mind. While I am always a strong advocate for my clients’ interests, the goal is not to battle it out with DEA (or any other governmental entity, for that matter) at every turn. I use my experience primarily to chart a course for my clients for effective compliance with all relevant laws and regulations regarding controlled substances. This is not always easy. The laws and regulations do not provide a clear road map for every possible scenario. There are “gray areas.” This is where my experience proves especially useful. I help to navigate my clients through any murky waters with a compliance strategy designed to avoid the dangers of bumping up against DEA enforcement priorities.
My approach is practical. I do not simply regurgitate the law. Creating a compliance strategy involves much more than that. An effective strategy must provide clear guidance to company management and the employees who work with controlled substances about processes that work and remain on the right side of the law. I am always mindful that you are running a business. These are not theoretical issues. Best practices must not simply be good ideas; they must work on the ground.
DEA Chronicles will continue to provide up-to-date law and policy news and analysis regarding all controlled substances issues. And Cote Law PLLC is here now to assist our clients with their particular needs and concerns. I look forward to working with you on both fronts.