In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization.
USP chief executive officer Ron Piervincenzi is consulting with stakeholders, reviewing the organization’s operations, and examining options for growth and change as part of the agenda for the next USP convention in April 2015.
Piervincenzi comes to USP with training in bioengineering and expertise in management gained at McKinsey & Co., where he worked on multiple projects involving regulatory and medical affairs for many parties involved in USP activities, including manufacturers of drugs, dietary supplements, veterinary medicine, and foods. As the biomedical world has become more complex, notes USP president Timothy Franson, USP needs leadership with deep scientific understanding, as well as strong management skills and broad experience in stakeholder areas.
A top priority for Piervincenzi is to strengthen USP relations with FDA, which is key for harmonizing and updating standards. One proposal is to establish more regular interactions between senior leadership of both organizations to better understand each other’s goals related to global quality, biosimilar testing standards, and priorities for monograph modernization.
USP’s core business remains the development and revision of monographs and general chapters on test methods. As always, leadership is required to gain agreement among multiple stakeholders on quality standards for biopharmaceutical products; broad acceptance of USP decisions can be difficult, as seen in recent debate over recommended test methods and assays to ensure appropriate levels of ingredients such as chondroitin sulfate sodium in medical products and dietary supplements.
USP schedules frequent stakeholder forums on drugs, excipients, dietary supplements, and veterinary medicines to provide opportunities for manufacturers, pharmacists, physicians, consumers, and other interest groups to weigh in with their perspectives.
Susan Schniepp, vice-president, Quality and Regulatory Affairs at allergy Laboratories, who in the past has raised concerns about USP’s standards-setting process, said in a recent interview with PharmTech that she detects greater interest by USP today in incorporating modern technologies into chapters more quickly and in encouraging broad input from all relevant parties. USP acknowledges its reliance on pharmaceutical industry support for its standards-development activities, and continues to work with manufacturers to gain voluntary submission of necessary data and material for developing monographs and providing reference standards. An expert panel is developing standards for producing synthetic peptides, a complex process that is detailed in a three-part article published in Pharmaceutical Technology and BioPharm International to encourage broad input on the current proposal.
The development of more complex biotech therapies has prompted increased USP focus on standards related to biosimilars. USP is looking for increased communication with European regulators to learn about their process for ensuring appropriate characterization of these products. Biosimilar “naming” also has emerged as an important issue for tracking brand and biosimilar products on the market, as there are questions about how to cross-reference in monographs a similar, but not identical, biologic.
Drug compounding has been a core issue for USP since its early days and now has gained prominence on its agenda due to serious drug quality concerns raised by some compounding operations. Public demand for assurance that compounded drugs meet standards for quality, consistency, purity, identity, and strength has prompted USP to launch a new effort to revise general chapters on compounding both sterile and non-sterile products.
USP also has expanded its global presence with offices in China, India, and Brazil, and the US Agency for International Development recently extended its program for providing assistance to regulatory authorities in third-world nations that strive to develop the capacity to ensure the quality and safety of locally produced medicines. Efforts continue to harmonize pharmacopeial standards and test methods for ensuring drug quality around the world, an important challenge for USP that is discussed further in the June 2014 issues of PharmTech and BioPharm International.