A Friday letter from bipartisan leaders of the House Energy and Commerce Committee to the comptroller general at the nonpartisan Government Accountability Office (GAO) called on the GAO to examine issues about activities in foreign drug inspections and foreign offices by the Food and Drug Administration (FDA).
“According to FDA, imports of pharmaceutical products have more than doubled since 2002,” 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) wrote in the letter. “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.”
Despite reports from the GAO on how the FDA has responded to globalization, questions remain about changes that have taken place and the work that remains.
“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,” the letter said. “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.”
The letter asks the GAO to revisit certain areas of concern as a means of reassessing the FDA’s changes and determining what accomplishments have been achieved in regards to foreign drug inspections and foreign offices.