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The Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on Tuesday, December 10 entitled, “Securing the U.S. Drug Supply Chain: Oversight of the Food and Drug Administration (FDA)’s Foreign Inspection Program."
ASA is pleased that Congress continues to examine the issue of pharmaceutical quality as related to drug shortages. In September 2018, ASA hosted, with other stakeholders, a summit: Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure. The meeting examined vulnerabilities in the supply chain and revealed many of the issues acknowledged in the hearing. In fact, one of the recommendations stemming from the summit recognized the need to streamline the global regulatory environment and harmonize international standards. In addition, other recommendations asked Congress to enact legislation requiring a risk assessment of foreign source active pharmaceutical ingredients (APIs) and recommended that FDA work with manufactures to develop a quality rating system.
Testimony at the hearing revealed that foreign manufacturers are a critical source for American drugs; the FDA has estimated that nearly 40 percent of finished drug products and 72 percent of API are manufactured outside the United States. Several Subcommittee members noted the importance of securing the global pharmaceutical supply chain to prevent drug shortages.
Witnesses at the hearing included Mary Denigan-Macauley, Ph.D., Director of Health Care, Government Accountability Office (GAO), and Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research at FDA.
One of the primary mechanisms for overseeing the United States’ drug supply is through FDA inspections. In 2010, GAO found that the FDA was not conducting enough overseas inspections, at which point the FDA gained additional resources to address the issue of disparities between the number of overseas inspections and those in the U.S. According to a recent report, however, GAO concludes that the FDA continues to face challenges in conducting foreign drug inspection in India and China.
GAO testimony mentioned that issues remain regarding advance warnings to foreign facilities, reliability on independent translators and quality/timeliness of data. Similarly, the FDA expressed that staffing was the biggest challenge— both administratively and with foreign vacancies. The agency also mentioned the lack of transparency with manufacturing quality and cited their recent drug shortages task force report, Drug Shortages: Root Causes and Potential Solutions, recommending the need for a quality rating system, which ASA supports.
ASA looks forward to working with Congress and the FDA to address challenges in U.S. dependence on foreign-sourced pharmaceutical ingredients.
