This report builds upon current insights with findings from a new survey which examines two important stakeholder groups and analyzes what drives these groups’ use and trust in OTC medicines.
CHPA supports FDA's goals of reducing medical errors, simplifying device use information into data systems, identifying devices with adverse events, facilitating recall efficiency, and focusing communication.
Enclosed are comments on "Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products that Contain Acetaminophen."
Presentation by Scott Melville, president and CEO of CHPA regarding using innovative technologies and other conditions of safe use to expand which drug products can be considered nonprescription.
The reason we’re here today is to discuss a provision of the Affordable Care Act that requires holders of tax‐preferred healthcare accounts to seek a prescription if they wish to use those accounts to purchase an OTC medicine. We believe this requirement is bad policy for both the American consumer and the U.S. healthcare system.
The proposed rule will require child-resistant packaging for OTC and prescription products containing the equivalent of 0.08 milligrams or more of an imidazoline.
CHPA encourages FDA to work with industry and other stakeholders to develop and discuss alternatives to an ingredient ban. Given the extremely low levels of gluten in OTC drugs today, a ban would unnecessarily disrupt the supply chain and may limit the availability of important products relied on by millions of consumers.
