Comments regarding "Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph".
These comments are submitted in response to the public meeting of June 26 on evaluating drug names for similarities, which was co-sponsored by the FDA, PhRMA, and the Institute for Safe Medication Practices.
Letter to Daniel E. Troy, Esq. regarding whether there should be different trade-name evaluation procedures for different classes of drugs (Rx versus OTC).
CHPA supports the intent of the proposed rule to add a bar code to many medications intended to be dispensed in hospitals. We support the view that this rule will help arm busy healthcare professionals with technology to help avoid medication mistakes.
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.
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.
