CHPA says exclusivity periods are needed to help firms recover their investments needed to support monograph proposals.

"Innovations such as these require significant investments in data, including clinical efficacy trials, safety studies or special types of consumer behavior studies to show consumers understand how to follow labeled directions," the trade group said in a statement to the Pink Sheet.

It added that firm that sponsor innovative monograph proposals need a 24-month periods "to establish their brand and raise awareness in the marketplace before others follow." Firms typically need several months to produce market inventories of new products and complete labeling requirements and they need to coordinate product launches with retailers’ planning cycles.

"If a manufacturer misses that planning cycle, they’ve missed a year. This retail planning cycle is a reality not present in the prescription medicine world," CHPA said.

Under the current system, monograph formulations and indications can be used by any FDA-certified drug manufacturer, unlike approved applications for new OTC and Rx drugs, which are for the sponsors' products only. Some OTC products marketed after new drug application approvals, notably those containing ingredients switched from Rx-only, are eligible for three-year market exclusivity.

OTC Monograph Reform Momentum Carries Potential Exclusivity Snag

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