Skip to content

GAO Report Confirms: Clear Authority Needed to Strengthen Oversight of Drug Compounding

HELP Committee Chairman Tom Harkin and Ranking Member Lamar Alexander Lead Effort on Legislation to Clarify Oversight of Large-Scale Drug Compounders 

Report: “Differing FDA Authority to Oversee Compounded Drugs Across the Country Has Resulted in Gaps in Oversight of Drug Compounding”

WASHINGTON, D.C. — A newly-released report from the nonpartisan Government Accountability Office (GAO) confirms that legislation is needed to clarify the U.S. Food and Drug Administration’s (FDA) oversight of large-scale drug compounders. Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously approved legislation introduced by Committee Chairman Tom Harkin, Ranking Member Lamar Alexander, Senator Pat Roberts (R-KS), and Senator Al Franken (D-MN) to improve the safety of compounded drugs.

“Tainted compounded injections from the New England Compounding Center claimed two more lives this week. We know that if we fail to clarify FDA’s authority to regulate large-scale drug compounders, this sort of public health crisis is bound to happen again,” Chairman Harkin said. “The nonpartisan Government Accountability Office has confirmed that gaps remain in the oversight of drug compounding, and that federal legislation is necessary to ensure the safety of compounded drugs.”

“This nonpartisan compounding report recommends that Congress work on ‘clarifying FDA’s authority,’ and that’s exactly what we’ve done with our legislation.  We’ve worked to put one agency clearly on the flagpole and in charge for each area of compounding or drug manufacturing, so that we don’t have another deadly outbreak for the same reason we did last year. I hope that this report will further encourage my colleagues to support and pass the bill as soon as possible,” Ranking Member Alexander said.

The GAO points to the lack of clear authority of whether FDA can regulate compounding pharmacies that make sterile products without, or in advance of, a prescription and sell those products across state lines. The nonpartisan office wrote that “this lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” posing a grave threat to public health. Further, GAO recommends that “Congress should consider clarifying FDA's authority to regulate entities that compound drugs.”

The legislation passed by the HELP Committee, now known as the Pharmaceutical Quality, Security, and Accountability Act, makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the FDA. It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.

The Committee’s work came in response to a fall 2012 fungal meningitis outbreak that to date has caused 749 illnesses and 63 deaths, and was directly traced to contamination in steroid injections produced at a large-scale compounder, the Massachusetts-based New England Compounding Center (NECC). Earlier this year, a bipartisan investigation by the Committee clearly documented the ongoing risk to the public health from large-scale drug compounding companies that is addressed by the bill.

Last week, a bipartisan coalition of HELP Committee senators—including Chairman Harkin and Ranking Member Alexander—urged the Senate to act on their legislation in order to prevent another public health crisis like the 2012 fungal meningitis outbreak. Just this week, two Michigan residents died as a result of the tainted steroid injections that came from the New England Compounding Center.

Click here for more details on the legislation.

Click here to read the GAO’s report.