Monograph Reform Legislation In Play As FDA, OTC Industry Get Real On Changes
FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.
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Both bills allow 18-month market exclusivity periods for marketers of some products made available through additions or changes to OTC monograph, through which the majority of nonprescription drugs are made available in US. Senate bill in markup 31 October.
Industry and the FDA agree that the OTC drug monograph system is direly in need of reform, but innovating with noncompliant dosage forms and indications, without approved new drug applications, is a risk companies need to weigh seriously, says Arnall Golden Gregory partner Alan Minsk. The FDA offers perspective on its OTC monographs for acne and antiperspirant products.
US consumers currently don't have access to enough private label/store brand competition for Aleve PM (naproxen/diphenhydramine), the FDA decides in granting Apotex its first OTC ANDA approval with Competitive Generic Therapy designation and eligibility for a type of exclusivity unlike any other previously allowed for OTCs.