On April 3, 2014, Food and Drug Administration (“FDA”) Commissioner Margaret A. Hamburg, MD testified at a Senate Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies hearing on FDA plans for regulation of compounding pharmacies. Dr. Hamburg addressed the agency’s increased funding for regulation of compounding pharmacies as proposed in the fiscal year 2015 federal budget; FDA would be allocated $25 million in budget authority for enhanced pharmacy compounding oversight activities in the coming year. “Serious product safety and quality lapses in recent years have caused serious public health situations, most notably those involving foodborne illness and the compounding of unsafe drugs, so FDA is seeking increases in order to strengthen oversight of the pharmacy compounding industry and to support food safety and implementation of [the Food Safety Modernization Act].”
Dr. Hamburg noted that since a 2012 fungal meningitis outbreak, “28 firms ceased sterile operations. . . . FDA has learned of at least 20 compounders that may have shipped contaminated drug products, and has received at least 125 reports of adverse events, including serious infections, associated with drugs.” Dr. Hamburg expressed the agency’s intent to “continue risk-based, follow-up, and for-cause inspections of compounding pharmacies to identify pharmacies with deficient sterile compounding practices.” As part of this initiative, FDA will be “encouraging purchasers of compounded products to buy from registered outsourcers, a new category of compounder created by [the Drug Quality and Security Act] and that will be subject to enhanced FDA oversight and federal quality standards.”
Dr. Hamburg’s statement before the subcommittee is available here.