Regulatory Mediator

Regulatory Mediator

Mediation is an increasingly used tool both by courts and parties to avoid litigation. When a dispute involves regulatory issues, such as FDA compliance questions, a regulatory mediator can help parties reach a resolution without spending valuable time educating a mediator about the regulations. Common regulatory disputes involve Lanham Act for unfair trade practices, trademark or patent disputes, personal injury, and contract disputes ranging from distribution or contract manufacturing agreements to drug or device development. In regulatory disputes, the parties will often present competing versions of FDA regulations or FDA enforcement actions. A mediator will need to quickly understand what regulations are controlling and the key facts determining compliance. This can be a difficult job for a mediator lacking a regulatory background.

Mediation is one of several alternative dispute resolution (ADR) options available to parties. A mediator works with both parties as a neutral facilitator working to negotiate an agreeable resolution. Other ADR methods, like arbitration, function similar to a private trial. A mediator does not make a decision for the parties like a judgment. A mediator is simply a neutral third party.

Most mediations will end with a mutually agreed mediation agreement. A mediation agreement may be binding depending on the individual jurisdictions. In general mediation, agreements are considered enforceable contracts. If there is ongoing litigation or court-ordered mediation then the mediation agreement becomes a court judgment. If no agreement is reached then the parties can continue the dispute in other forums like court.

Mediation is increasingly seen as an efficient use of both parties time and money compared to the rigors of discovery and trial. Parties with a regulatory dispute should consider engaging a regulatory mediator to resolve their dispute.

The FDA Atty firm now offers a certified mediator available for regulatory mediations. Contact our Research Triangle or Washington D.C. office for more information.

Share this:
Posted in , and tagged with

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

Leave a Comment

You must be logged in to post a comment.

Are you in trouble with the FDA?

Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.

Expert knowledge of FDA regulations that helps you strategically grow your business