WASHINGTON, DC - Bipartisan leaders of the House Energy and Commerce Committee today sent a letter to the Comptroller General at the nonpartisan Government Accountability Office (GAO) asking the office to examine some issues about the Food and Drug Administration’s (FDA) activities in foreign drug inspections and foreign offices.
“According to FDA, imports of pharmaceutical products have more than doubled since 2002. We import more than $52 billion in human drugs every year and many of these products come from countries with less sophisticated regulatory systems than our own. … The volume of imported drugs, the growing numbers of foreign entities producing these drugs, and the increasing complexity of the pharmaceutical supply chain have all significantly complicated FDA’s ability to provide sufficient oversight," wrote full committee Chairman Fred Upton (R-MI), full committee Ranking Member Frank Pallone Jr. (D-NJ), Subcommittee on Oversight and Investigations Chairman Tim Murphy (R-PA), and Subcommittee on Oversight and Investigations Ranking Member Diana DeGette (D-CO).
GAO has issued reports on how FDA has responded to globalization, but questions remain about what changes have taken place and what work lies ahead. The leaders continued that since 2010, “FDA has adopted a multipronged approach to address globalization and has indicated it is utilizing a variety of strategies to partner with other agencies and organizations around the world to strengthen its regulatory capacity. … While we recognize that FDA has implemented many changes since 2010, we remain concerned about the agency’s actual progress in meeting the demands of a global pharmaceutical supply chain."
Given these concerns, the bipartisan committee leaders are asking GAO to revisit these areas of concern to reassess FDA’s changes and determine what accomplishments have taken place in regards to their foreign drug inspections and foreign offices.
Read the letter online here.
