OTC Medicines

CHPA sees no need for the agency to initiate a rulemaking on this matter. Sufficient precedent already exists for an active drug ingredient to be simultaneously marketed in both prescription and OTC drug products based on narrow distinctions.

The following comments are submitted by the Joint Oral Care Task Group CHPA and the Cosmetic, Toiletry, and Fragrance Association with respect to the Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.

CHPA is deeply concerned that safe and effective medicines manufactured by its member companies are being diverted to manufacture meth. We understand the scope of this problem and are committed to the need for strong action to prevent the diversion of these important medicines to the illegal manufacturing of methamphetamine.

CHPA has supported and continues to support the timely provision of complete and accurate product information to healthcare professionals and patients in an easily accessible format, and commends the Agency for considering new approaches to disseminating emerging drug safety-related data.

CHPA and CTFA request a 60-day extension of the comment period on the Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for the Treatment and Prevention.

Comments of Consumer Healthcare Products Association before the Institute of Medicine of the National Academies Committee on identifying and preventing medication errors.

CHPA appreciates the opportunity to provide comments concerning U.S. Government positions in preparation for the 33rd session of the Codex Committee on Food Labelling of the Codex Alimentarius Commission.

In considering the safety of NSAIDs, the use of OTC NSAIDs should be clearly distinguished from long-term prescription NSAID use. OTC medicines have a different overall benefit-to-risk equation and a wider margin of safety than prescription NSAIDs.

Given the millions of units of tooth whitening products used by U.S. consumers and the remarkable safety profile of these products, we believe the U.S. data supports the Colipa recommendation for the marketing of cosmetic tooth whitening products.

CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.