Making Exclusivity Less Confusing? FDA Establishes Exclusivity Board to Assist with Exclusivity Determinations

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has established an Exclusivity Board to help evaluate marketing exclusivity decisions. The area of drug exclusivity remains a challenge for FDA and industry, frequently resulting in court challenges. The Board’s creation is an attempt to clarify whether exclusivity should be granted in a particular case and, if so, the scope of the exclusivity. The Board also answers industry questions related to exclusivity issues, reviews CDER exclusivity policies, and maintains records of exclusivity decisions.

The Board does not intend to resolve or answer questions related to every exclusivity decision. The Board’s jurisdiction is limited to issues related to five-year new chemical entity exclusivity, three-year new clinical trial exclusivity, and biological products exclusivity. However, even if a particular exclusivity decision falls within one of these categories, there is no assurance that the Board will review it.

The Board’s authority does not extend to decisions regarding 180-day generic drug exclusivity, seven-year orphan drug exclusivity, and six-month pediatric exclusivity. Where necessary, the Board will communicate with the FDA personnel responsible for handling these respective determinations.

While time will tell if the Board is able to provide guidance and consistency on exclusivity decisions, its creation is a positive step to try to address these complex, but commercially significant, issues.

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