How would you define Regulatory Intelligence & Policy, and how is it different than Regulatory Affairs or other Regulatory synonyms?
There are many different roles that contribute to a robust Regulatory team. Regulatory Intelligence & Policy involves policy coordination internally and externally with other external-facing departments of the company. Assessments of the regulatory impact of federal and state legislation are increasingly important parts of this role, along with international policy coordination. There’s also an opportunity for regulatory news coordination and delivery, monitoring of relevant regulatory developments, and disseminating assessments of that information internally. Ensuring that there is active participation by the company in trade association regulatory committees can be a part of this as well.
Internal roles of a Regulatory Intelligence team include applying knowledge of regulatory authority operations and health authority intelligence to company activities, often within project teams. This may include: explanation of PDUFA time tables and their application to specific filings; assessment of orphan drug options; overview of expedited review options; and coordination of internal working groups to comment on external Regulatory Intelligence & Policy issues.
Also, Regulatory Intelligence fields ad hoc requests from management, including analyses of regulatory precedence and competitive intelligence with a regulatory twist. Those are the roles I’ve seen in Regulatory Policy & Intelligence as applicable (and necessary) to most Regulatory Affairs teams in Life Sciences.
A former colleague of mine once said, “Anything above the Review division at the FDA is Regulatory Intelligence & Policy; anything at the Review division and below is Regulatory Affairs.” While simplistic, it’s a description of some value, although the caveat is that both Regulatory Intelligence & Policy and Regulatory Affairs should be working closely together to achieve the company’s regulatory agenda. One role helps create the application and pushes it through the agency; the other helps look at the rest of the environment that affects the company’s plans about its product line, pending submissions, currently licensed products, regulatory precedents, future competitors, unique patient populations, and regulatory opportunities.
Regulatory Intelligence areas of interaction are often externally focused. How does the company affect health authority policy making? How is the company participating in that process? Are company comments on regulatory developments going through its trade association? Or are we submitting our own company comments, and if so, what are they going to be? Regulatory Intelligence often coordinates that role.
In addition, Regulatory Intelligence & Policy also informs some of the work that is done legislatively for a couple of reasons:
- First, it’s been a trend for the last 15 years for Congress to try and write as much regulation into the law as it possibly can, leaving the regulatory agencies, including FDA, less wiggle room about details – that can be good or bad depending on how you view it, what the issue is, and its impact on your company
- Second, there’s a strong activist patient role now that has not been there before. As a result, patient organizations are utilizing the Congressional Oversight and Appropriations processes to affect change for patients and diseases
Regulatory Intelligence and Policy is a growing field within Regulatory Affairs and I’ve enjoyed my career experiences and feel the role has added immense value to regulatory operations.
About the Author: Anne Marie Finley, Managing Expert, YourEncore Regulatory Center of Excellence, and former Vice President, Government Relations & Public Policy at Celgene, is a subject matter expert in regulatory strategy for pharmaceutical and biotech organizations. As a former executive of Regulatory Policy and current President of Biotech Policy Group, Anne Marie has developed robust regulatory solutions and provided holistic perspectives for the entirety of her career. She is currently on the Board of Directors of the FDA Alumni Association and was named to the list of "Top 50 Global Thought-Leaders in Orphan Drugs and Rare Diseases" by the World Orphan Drug Congress as "an expert with an expert with access to different national regulators. Anne Marie has a unique holistic perspective on the challenges surrounding orphan drug development across multiple markets."
Be sure to stay tuned for a follow-up Q&A on Regulatory Intelligence & Policy, coming soon from YourEncore.