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.
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