The U.S. Pharmacopeial Convention (USP) submitted a series of public comments in 2014 in response to proposed regulations and policy initiatives by Federal agencies with an emphasis on appropriate appreciation and awareness of public standards. USP sets legally-recognized quality standards that help define the identity and purity of medicines, food ingredients and dietary supplements sold in the United States.
Below are summaries and links to USP comments submitted in 2014:
Drugs
• USP described to the Food and Drug Administration (FDA) possible approaches in addressing Over the Counter (OTC) monograph modernization and noted, “USP is committed to doing its part in removing barriers to innovation and the introduction of new products into the OTC system.”
• USP offered the Federal Trade Commission (FTC) and FDA background information on the manner in which chemical and biologic drugs are named, also underscoring to FDA that compendial identity is different from regulatory identity. USP emphasized the importance of “clarify[ing] the role and application of our standards, and why this role should not be confused with regulatory decisions regarding similarity or market access.”
• USP encouraged FDA to allow for alternative approaches to validation of analytical procedures and methods: “USP values its role as a ‘recognized source’ for analytical procedures and reference standards and appreciates its relationship with FDA and industry.”
Food Ingredients
• USP proposed FDA approach economically-motivated adulteration (EMA) separate from preventive controls, focusing on vulnerability assessments and ways to mitigate food fraud: “EMA should be addressed as its own unique category of food adulteration.”
• Additionally, USP highlighted its proposed guidance on food fraud mitigation, noting it offers “a common framework to guide manufacturers and regulators in implementing effective mitigation approaches to safeguard the most fraud-vulnerable and impactful ingredients in the supply chain.”
• USP outlined for the U.S. Department of Agriculture (USDA) a possible role for standards for the identity of honey, noting that it would be scientifically feasible to create such a standard, “providing greater certainty to consumers and manufacturers that honey is in fact honey and is of the appropriate purity – thereby helping to prevent illicit and/or unknown and potentially harmful substances from entering the food supply.”
Health Care
• USP responded to a request for comment by the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS), related to prescription benefits under the Patient Protection and Affordable Care Act (ACA) – noting the role USP Medicare Model Guidelines have played in the first round of implementing ACA, but also acknowledging the challenges experienced by the CMS Center for Consumer Information and Insurance Oversight (CCIIO) and stakeholders in adapting those Medicare Model Guidelines to support the needs outlined in the Affordable Care Act. USP underscored the expertise provided by USP’s expert committees in setting public standards for outpatient formularies and emphasized a desire for continued discussions, stressing “we (USP) would welcome ongoing dialogue to further explore developing a classification tool specifically for an ACA population.”
Standards Development
• USP urged the Office of Management and Budget (OMB) to “avoid over reliance on voluntary consensus standards and to provide the necessary flexibility and discretion for Federal agencies to continue to use standards developed by other means.” USP noted the benefit of non-consensus standards – such as USP quality standards for drugs, dietary supplements, and food ingredients – developed through an objective, purely scientific process that utilizes the work of independent experts, adding “each type of standard has its place.”
The U.S. Pharmacopeial Convention is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are used worldwide.
Release Date: December 30, 2014
Source: The U.S. Pharmacopeial Convention
