Emerging markets are playing an increasingly important role in the strategy of pharmaceutical companies from both a revenue and supply perspective. Attendant to that increased globalization comes additional regulatory oversight and cooperation. The author highlights recent efforts by FDA to develop greater collaborative and innovative approaches in overseeing the pharmaceutical supply chain.
The increased globalization of the pharmaceutical industry is not only reflected in the rising importance of emerging markets to pharmaceutical companies’ bottom lines, but also in the supply chain for pharmaceutical ingredients. As overall trade, including pharmaceuticals, increases between the United States and other countries, regulatory agencies are tasked with overseeing an increasingly more expansive and complex supply chain.
Challenges of globalization
To address these challenges, FDA is using a variety of engagement strategies. Solomon noted that these efforts are in line with the 2012 US National Strategy for Global Supply Chain Security, which emphasizes a layered, risk-based approach for achieving global supply-chain systems that are secure, efficient, and resilient (1, 2). In 2011, FDA also released its report, Pathway to Global Product Safety and Quality, which outlines the agency’s strategy to transform itself from a predominantly domestically focused agency to one that is engaged in the complex, globalized regulatory environment (1, 3). Solomon further outlined some of those activities as they apply to international offices, risk-based monitoring of imported products, technical cooperation and capacity building, and new laws to increase FDA’s authority.
International offices and foreign posts. FDA’s international offices and posts are designed to build partnerships with foreign counterparts by providing enhanced opportunities for cooperation and capacity building. They also are designed to expand the agency’s knowledge base and provide a platform for inspection of foreign facilities. The agency has a permanent FDA presence in 12 foreign posts in nine countries with employees located in China, India, Latin America, Europe, the Middle East, and South Africa, noted Solomon (1).
Risk-based monitoring of imported products. Solomon also pointed to FDA’s strategy of using risk-based monitoring for imported products. “While FDA does not have sufficient resources to physically inspect all imported shipments, even if we had such resources, physically inspecting all imports would be neither practical nor strategic,” said Solomon. “However, the agency electronically screens all imports using an automated risk-based system to determine if shipments meet identified criteria for physical examination or other review,” he said (1). To enhance the agency’s ability to target high-risk products, FDA developed the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). PREDICT is a screening system that uses intelligence from many sources, such as intrinsic product risks, past inspection results, intelligence data, and other information that would affect shipments, to provide the entry reviewer with risk scores on every import line. PREDICT uses information sources that include FDA and US Customs and Border Protection (CBP) data as well as data collected from foreign offices, foreign regulatory counterparts, other federal agencies, and US state counterparts. It also uses risk analyses received from agreements with academic institutions and international organizations (1).