House Democrats Release Report on Flawed Compounding Pharmacy Oversight

Press Release

By:  Henry Waxman Frank Pallone, Jr. John Dingell Diana DeGette
Date: April 15, 2013
Location: Washington, DC

Congressman John D. Dingell's (D-MI12) request for state-by-state responses to oversight of compounding pharmacies led to the release of a report today from Democrats on the House Committee on Energy and Commerce in the wake of the recent deadly fungal meningitis outbreak.

The report, released today by Congressman Ed Markey (D-MA05), found that compounding pharmacies are going largely untracked, under-regulated, and under-inspected by states across America.

"This report clearly indicates what we've known for quite some time--that there is no clear, functioning, or uniform process for all 50 states to manage and oversee compounding pharmacies, and more must be done to give the U.S. Food and Drug Administration the clarity and authority they need to do absolutely everything within their power to monitor these facilities, hold them accountable to clear standards, and keep the American people safe," said Dingell. Across this country and throughout this report, we see clear instances of states admittedly unable or unauthorized to properly inspect, monitor, or manage the rising number of compounding pharmacies we're seeing. This must change, for the health and wellbeing of all Americans who count on, and are deservedly owed, access to safe prescription drugs."

Following the meningitis outbreak originating from a Massachusetts compounder that killed dozens and sickened hundreds, Dingell joined Markey, along with Reps. Henry A. Waxman (D-CA33), Frank Pallone (D-NJ06) and Diana DeGette (D-CO01), to ask for reports from all states on their oversight of compounding pharmacies.

The report, "State of Disarray," compiles responses from the states queried in the investigation, and shows that many states lack the ability to effectively inspect, track, or police activities within their borders and across state lines when the drugs are shipped.

Along with the report's findings, the analysis demonstrates that because states have largely failed to oversee and regulate compounding pharmacies, the Food and Drug Administration must be given authority to set and enforce clear standards for compounding. The report includes state-by-state information on inspections, record-keeping, licenses, and other aspects of compounding oversight.

"In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease and death," said Rep. Markey. "Even states with stronger compounding standards cannot effectively police the activities of pharmacies in 49 other states that sell drugs across state lines, which is why the FDA must step in and protect public health. Government's first duty is to protect its citizens and right now most states are not doing their duty when it comes to regulating and policing compounders."

"Our current system for regulating compounded medicines is in disarray," said Waxman. "There are no clear lines governing whether it should be FDA or the states overseeing compounding pharmacies. The validity of FDA's authorizing statute on compounding is in question, and this report shows that states face major challenges in policing the practice of pharmacy compounding. It is time for Congress to do its job and pass legislation that clearly delineates who is in charge of what. And now. American lives are at stake."

"Compounding pharmacies serve a variety of important functions, but they must operate with only the highest safety standards, anything less is absolutely unacceptable," said Pallone. "That's why I eagerly joined with my colleagues in calling for an investigation into what went wrong at the New England Compounding Center and what steps need to be taken to prevent something similar from ever happening again. This report's findings are shocking and shed light on an industry that often operates with little oversight and whose lack of regulation could continue to put lives at risk. Action must be taken immediately to remedy the risks from compounding pharmacies and it is time for the FDA to step in and keep our supplies of medicines safe."

"For the past two decades, the Food and Drug Administration has operated under unclear authority and has been hamstrung in their efforts to work with states to ensure compounded drugs are safe for our citizens," said DeGette. "Congress must act to provide the clarity in the law that is so desperately needed, and it must do so before another tragedy occurs."

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