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Cummings and Tierney Release GAO Report on Drug Compounding

Jul 31, 2013
Press Release
Members Urge Action on Legislation to Protect Nation’s Drug Supply

Washington, DC —Today, Rep. Elijah E. Cummings, Ranking Member of the House Committee on Oversight and Government Reform, and Rep. John Tierney, Ranking Member of the Subcommittee on National Security, Homeland Defense and Foreign Operations, released a report from the Government Accountability Office (GAO) on the oversight of pharmaceutical drug compounding.

Cumming and Tierney requested the report last year after a fungal meningitis outbreak from a contaminated compound drug led to more than 50 deaths and hundreds of illnesses.

“This new report makes clear that the authority to regulate pharmacies engaged in drug compounding is unclear and inconsistent at the state and federal levels,” said Cummings.  “Hopefully, this report will give added impetus to legislative efforts in the House and Senate to address this problem and prevent senseless deaths caused by contaminated compound drugs.”

“Last year, an outbreak of fungal meningitis that originated at a Massachusetts compounding facility, killing over 50 people and sickening hundreds more, raised serious concerns about federal and state oversight of compounding pharmacies,” said Tierney. “In response, I joined Ranking Member Cummings in calling for a full investigation of the compounding industry and its regulations. Today, the GAO is releasing the results of that investigation and is recommending that congressional and executive branch action is needed to ensure the safety and reliability of compounded drugs. I am pleased that the Senate appears to be moving forward on this issue and urge the Republican-led House to take responsible action on it.”

The GAO report finds:

  • “The exact proportion of all prescriptions filled by compounded drugs is unknown. … [I]n 2013, the International Academy of Compounding Pharmacists estimated that the compounding industry made up 1 to 3 percent of the U.S. prescription drug market.”
  • “The authority of the FDA … to oversee drug compounding is unclear.  Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country.”
  • “This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps to oversight of drug compounding.”
  • “Some states do not have the resources to inspect pharmacies on a regular basis.  Instead, these states inspect pharmacies only in response  to a complaint or a reported adverse drug event.”

In response to the GAO report, FDA wrote:  “The report accurately details the limitations associated with FDA’s current authority.  FDA’s current authority does not provide the agency with the tools suited to effectively regulate certain drug compounding operations, and the findings in the report support the need for legislation to allow FDA to appropriately regulate this evolving industry.”

There have been several legislative efforts to improve the safety of compounded drugs by clarifying the oversight responsibilities of state and federal authorities.

In May, the Senate Committee on Health, Education, Labor and Pensions unanimously passed S. 959, the Pharmaceutical Compounding Quality, Security, and Accountability Act, although the legislation has not come to the Senate floor.  Last week, a bipartisan coalition of Committee Senators urged action on their legislation.

The House has passed a bill relating to a “track and trace” system for pharmaceutical drugs that was reported out of the Energy and Commerce Committee, but no action has been taken to date on legislation relating to drug compounders.

113th Congress