The Coalition is pleased that FDA has issued guidance that takes a risk-based approach to compliance. We strongly support this approach as a more realistic and effective way to protect public health.
CHPA is supportive of the FDA’s proposed regulation to implement Section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act. However, CHPA encourages FDA to make the implementation of the Act less burdensome on industry while ensuring the safeguards that Congress sought to construct for the American public.
CHPA is supportive of the FDA’s proposed regulation to implement Section 305 of the Bioterrorism Act. However, CHPA encourages FDA to reconsider its position with respect to the definition of food and the confidentiality afforded to the information provided to the agency.
We understand that FDA is considering a switch of a second generation antihistamine, from prescription to OTC status, over the objections of the company. CHPA opposes a policy to force switch over the objections of the drug sponsor.
CHPA endorses PhRMA’s analysis and conclusions concerning the First Amendment protections for trade names. These legal principles apply equally to the selection and use of trade names for OTC medicine and dietary supplement products.
CHPA supports efforts to reduce medication errors, including those that encompass errors in information acquisition by the consumer, who is the principal end user of self care products, and by health professionals as well.
The January 4 Federal Register included a request for comments on the Secretary’s initiative and advisory committee on ways to reduce challenges that can inhibit the delivery of health care or the development of medical products. We have two general comments and three specific comments.
Enclosed for FDA review are final reports on 2-year carcinogenicity studies with topically applied benzoyl peroxide gels in F344 rats and B6C3F1 mice submitted by the Benzoyl Peroxide Study Group of CHPA.
CHPA wishes to draw attention to varying restrictions on how nonprescription medicines can be displayed or accessed among European Union Member States as a barrier to market entry for such products.
