FDA's Center for Drug Evaluation and Research ("CDER") establishes standards, known as monographs, for over-the-counter ("OTC") therapeutic drug classes. In late March, CDER held a hearing to address pitfalls with the current monograph system and examine potential reforms. CDER Director Janet Woodcock said current challenges include the lengthy, three-phase rulemaking process for promulgating final monographs and the difficulty of keeping up with advances in scientific knowledge and safety information once a monograph is finalized. She suggested adopting an alternative to rulemaking as a way to complete monographs more efficiently. Some attendees at the hearing expressed concerns about changing the monograph system, for example noting that 80 percent of monographs are final and that FDA can establish reasonable schedules within the current procedure to complete the remaining bunch.
These considerations come as FDA attempts to revamp other procedures for regulating products. On March 25, FDA issued a proposed rule to simplify the process by which medical devices may be reclassified. For more information, see the Jones Day Alert discussing this proposal.
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