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.
CHPA takes this opportunity to share comments on the agency's proposed rule for Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests.
The industry favors and supports the development of reasonable guidance. However, the agency’s attempt to redefine the NDI notification process contradicts the letter and spirit of DSHEA. The Draft Guidance would undo nearly two decades of agency practice and policy.
