CHPA appreciates the opportunity to provide comments on the Alternative Database Rule Proposal that has been made by Commissioners Anne Northup and Nancy Nord.
This report examines the role of OTC medicines in the U.S. healthcare system as reflected through professional treatment guidelines, medication use data, as well as clinical and consumer research.
CHPA does not believe scheduling of dextromethorphan under the Controlled Substances Act is warranted. The prevalence and scope of reported abuse is limited. CHPA believes that there are more effective interventions to address OTC cough medicine abuse.
CHPA and its members support the Transparency Initiative and support FDA's goal of facilitating transparency that promotes public health and innovation, while maintaining confidentiality of trade secrets and individually identifiable patient information.
In order to ensure the continued safe reporting of adverse events associated with our member's products and prevent consumer confusion, we strongly believe OTC and dietary supplement product incident reports should not be included in the CPSC safety incident database.
Today, the manufacturers of OTC medicines containing pseudoephedrine call on Congress to improve the Combat Methamphetamine Epidemic Act by requiring a unified, national electronic tracking system to block illegal sales of PSE‐containing medicines.
CHPA and its member companies have an interest and expertise in dosage delivery devices and support FDA's efforts to develop guidance for industry on this important topic.
