GAO auditors concluded that the FDA's authority over drug compounding is “unclear,” noting in particular that two federal circuit court decisions have led to differing FDA authority in different regions of the country.
“According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have created challenges in FDA's ability to inspect and take enforcement action against entities engaging in drug compounding,” the GAO noted in its report. “FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority.”
The 50-page study's recommendations include a call for executive action as well as legislative action.
The FDA commissioner, the GAO said, should take steps to consistently collect reliable and timely information in the agency's existing databases on inspections and enforcement actions associated with compounded drugs. It also suggested that the FDA's database should “clearly differentiate” those manufacturers of FDA-approved drugs that the agency inspects for compliance with good manufacturing practices “from those entities compounding drugs that are not FDA-approved and that FDA does not routinely inspect.”
The GAO report comes as Congress considers at least three bills that attempt to address the regulatory holes that allowed the deadly meningitis outbreak to occur. The House Energy and Commerce Committee held a hearing to examine two bills in the House from Reps. Morgan Griffith (R-Va.) and Edward Markey (D-Mass.) and one from Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-Iowa). All three measures agree that traditional compounding should be regulated mostly by the states and should be exempt from certain FDA requirements that pertain to new drug approval, good manufacturing practices and labeling, according to a summary from the committee.
Reps. Elijah Cummings (D-Md.) and John Tierney (D-Mass.) requested the report. In addition to the analysis of federal regulation, they asked the auditors to review what states are doing or planning to improve their oversight of compounders, and the report describes work in California, Connecticut, Florida and Iowa. Florida, for example, required all pharmacies—including those in the state and out of state that sell drugs in Florida—to notify the Florida Board of Pharmacy about their compounding activities.
The GAO submitted a draft of its findings to HHS, which agreed with the conclusion that Congress consider clarifying FDA's authority on drug compounding. HHS also responded that the FDA will consider whether it's possible—or appropriate—to distinguish in its database those compounding pharmacies that register voluntarily from the conventional manufacturers of FDA-approved drugs that are required to register.
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