Submissions

Letter from the Consumer Healthcare Products Association, the Food Marketing Institute, the Healthcare Distribution Management Association, and the National Association of Chain Drugstores regarding controlled substances and Lis I chemical registration application fees.

With this letter, the Consumer Healthcare Products Association expresses its great interest in the selection of the industry representative to serve on the Nonprescription Drugs Advisory Committee.

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by the Joint Oral Care Task Group CHPA and the Cosmetic, Toiletry, and Fragrance Association with respect to the Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.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

The CHPA Dietary Supplements Committee supports maintaining A-priority level for several goals listed in the 2005 Program Priorities that specifically address dietary supplement issues. We also support efforts to fully implement the Dietary Supplement Health and Education Act of 1994 as currently written.

CHPA and CTFA request a 60-day extension of the comment period on the Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for the Treatment and Prevention.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