Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke at the United States Pharmacopeial (USP) Convention last week and put forth her underlying philosophy as commissoner: building collaborative models to address ongoing challenges to secure public health, which includes oversight of pharmaceutical products. Part of that effort involves building greater cooperation with USP in working on the development and modernization of USP monographs as well as strategies for combating adulteration of products and ensuring product quality.
Hamburg emphasized that the agency’s interest in working more closely with USP is part of a larger policy position by FDA to seek collaborative models between regulators, industry, and other organizations to meet the rising need for science-based regulation in an increasingly complex and global supply chain. “After I become Commissioner, many people began asking whether the agency is now leaning pro-industry or pro-consumer,” said Hamburg in her remarks to the USP Convention. “This is the wrong way to think about FDA’s role. Both consumers and industry groups have a tremendous stake in a strong FDA that takes science-based action on behalf of public health….An FDA that can promote health and well-being through quality products and acts quickly and strategically to protect consumers from unsafe products earns the trust and confidence it needs to do its job well.”
To meet that goal, Hamburg outlined two major priorities: increasing FDA’s scientific capacities to strengthen the field of regulatory science and responding to the growing demands of globalization as evident by the exponential increase in FDA-regulated imports (i.e., drugs, food) to the United States. She estimated that 20 million shipments of FDA-regulated imports are expected to come into the US this year from more than 150 countries compared with approximately 6 million shipments 10 years ago. “FDA simply does not have—and will never have—the resources to inspect every foreign manufacturer, or every shipment of products from overseas. So the new global reality requires that we build partnerships to handle the load,” she said.
Hamburg said that such an approach requires FDA to work more closely with other national regulatory authorities, other international and national organizations, and with industry. “We must find new ways to harmonize standards and approaches, as well as share information,” she said.
Part of that effort, says Hamburg, is to further build a collaborative relationship with USP. “Clearly many of our interests and priorities are aligned,” she said. “In some earlier discussions with USP, we have talked about opportunities and strategies to promote public health through our work together. There is a lot to be done,” she said.
She said that one of the most pressing tasks is to update monographs, pointing to a successful collaboration between USP and FDA in updating standards for heparin in the wake of the problems with adulterated heparin. “This type of collaboration is essential…and can be used as a model for how to move forward proactively to modify monographs in a way that they can identify counterfeited or intentionally adulterated products…before they enter the healthcare system,” she said. “Now, we must jointly identify drug ingredients and products that would benefit from an up-to-date monograph..starting with those that have the greatest impact on public health.”
FDA’s Office of Regulatory Affairs supports the USP Reference Standard Program through a Cooperative Research and Development Agreement, and Hamburg spoke of three future initiatives to take place under this agreement to expand efforts to promote the quality, purity, and efficacy of current and new drugs. First, Reference Standard Candidate Assessments will test standard candidate materials that are controlled substances. Second, to combat economic adulteration, FDA and USP will exchange information on hand-held device applications designed to screen drugs for adulteration or contamination and will explore ways to integrate the requirements of those new technologies into USP’s documentary standards. And third, FDA will assist in the development and modernization of USP monographs providing enhanced tests and assays to better assess and characterize drug ingredients and products.
Adapting regulatory and compendial approaches with a mindset to more collaborative efforts to deal with the evolving dynamics of the pharmaceutical industry is a positive development. The complexity and broadening of the global pharmaceutical supply chain, along with the greater complexity of new drug development, requires FDA, other national and international regulatory bodies, standard-setting organizations, and science-based organizations, to raise the bar in oversight through new models of cooperation, better use of scientific technologies, and risk-mitigation strategies. The recently announced initiatives between USP and FDA are good steps in that direction.