A House Energy and Commerce subcommittee questioned Food and Drug Administration (FDA) Commissioner Margaret Hamburg on April 16, 2013, about the agency’s oversight of compounding pharmacies as part of an ongoing congressional investigation into FDA’s response to a fungal meningitis outbreak that purportedly resulted in 53 deaths and sickened more than 700.
The committee has also released a staff report based on a review of thousands of FDA documents. According to Oversight and Investigations Subcommittee Chair Tim Murphy (R-Pa.), the documents show that the agency had been notified before the outbreak by doctors, patients, providers, and whistleblowers about questionable practices and conditions at the New England Compounding Center, which produced the drugs linked to the outbreak, but “focused on perfecting [its] legal reasons for inaction instead of protecting families.”
Rep. Edward Markey’s ((D-Mass.) staff issued a report titled “State of Disarray: How States’ Inability to Oversee Compounding Pharmacies Puts Public Health at Risk.” Its premise is that with pharmacies under the jurisdiction of state regulators and given conflicting judicial rulings regarding FDA’s authority over compounding pharmacies, Congress must act to give the agency the necessary authority to avoid future outbreaks. The report summarizes findings from House Democrats’ investigation of state boards of pharmacies and concludes that “most states are incapable of assuring the safety of compounded drugs [and] . . . poor record-keeping practices by the states make it difficult, if not impossible, for the states to identify compounding pharmacies with systemic, repetitive compounding safety problems.”
The Congressional Research Service (CRS) has also released a report on the regulation of compounded drugs. Titled “Federal Authority to Regulate the Compounding of Human Drugs,” the April 12 report provides a brief history of drug regulation in the United States and notes that FDA did not historically use its authority under the Food, Drug, and Cosmetic Act (FDCA) to regulate compounding because “it was widely recognized that compounded drugs could not meet the FDCA’s ‘new drug’ requirements. As the [U.S.] Supreme Court has noted, subjecting compounding pharmacies to the statute’s approval requirements ‘would as a practical matter, eliminate the practice of compounding, and thereby eliminate availability of compounded drugs for those patients who have no alternative treatment.’”
According to the CRS report, courts “that have examined the issue have all agreed that the FDA has some authority to regulate compounding. Specifically, case law appears to find that the FDCA does provide the federal government with the authority to prohibit pharmacists from manufacturing under the guise of compounding.” Still, “the legislative history of the FDCA appears to support the view that manufacturers were the intended target of the regulatory scheme imposed by the 1938 act,” and that its enactment did not disturb the traditional approach to pharmacies which are subject to state oversight. The CRS report concludes, “absent further congressional action, the limits of the FDA’s authority to regulate all forms of compounding will likely continue to be unresolved.”
Meanwhile, FDA has issued a statement to report that it has conducted 29 of 31 priority inspections of compounding pharmacies and concluded that most employed sterile drug-production practices that create a risk of contamination. Among FDA’s observations were “incomplete and/or inadequate drug product batch failure investigations, inappropriate and/or inadequate clothing for sterile processing, lack of appropriate air filtration systems, and insufficient microbiological testing.” FDA coordinated most of the inspections with state oversight officials because it does not have authority over those compounders operating within the bounds of traditional pharmacy compounding and indicated that it will refer appropriate cases to state regulators for enforcement. See 2013 FDA Pharmacy Inspection Assignment, April 11, 2013.