Compounding pharmacies are going largely untracked, unregulated and under-inspected by states across America, according to a new report released today by Rep. Ed Markey (D-Mass). Following the meningitis outbreak originating in a Massachusetts compounder that killed dozens and sickened hundreds, Rep. Markey, along with Reps. Henry A. Waxman (D-Calif.), John Dingell (D-Mich.), Frank Pallone (D-N.J.) and Diana DeGette (D-Colo.), quizzed all states on their oversight of compounding pharmacies, which mix specialty drugs.
The report, "State of Disarray", is a shocking compendium of the responses from the states queried in the investigation, showing that they are largely leaving compounding pharmacies to their own devices, without the ability to effectively inspect, track or police activities within states and across state lines when the drugs are shipped.
The full report prepared by the staff of Rep. Markey is available HERE. Along with the report's findings, it 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 safety standards. 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."
Rep. Henry Waxman (D-Calif.) said, "Our current system for regulating compounded medicines is in disarray. 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."
Rep. John Dingell (D-Mich.) said, "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. 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."
Rep. Frank Pallone (N.J.) said, "Compounding pharmacies serve a variety of important functions, but they must operate with only the highest safety standards, anything less is absolutely unacceptable. 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."
Rep. Diana DeGette (D-Colo.) said, "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. Congress must act to provide the clarity in the law that is so desperately needed, and it must do so before another tragedy occurs."
Examples of the major findings of the report include:
--State boards of pharmacy generally do not know which pharmacies engage in compounding. For example, only Mississippi and Missouri routinely track the number of compounding pharmacies in their state.
-- None of the states have requirements for pharmacies to disclose the volumes of compounded drugs they produce or whether compounded drugs are being sold across state lines.
-- Only thirty-two states were able to provide historical data on the number of licensed pharmacies in their states.
--Thirty-seven states do not routinely track which pharmacies are providing risky sterile compounding services, the service which led to the meningitis outbreak.
-- States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems.
-- On average, states employ just 5 inspectors (a range of 1-30 inspectors was reported) with responsibility to inspect all pharmacies, and only 19 states provide their inspectors with special training to identify problems with sterile compounding.
-- States are unable to effectively police compounded drugs shipped into their states from other states.
Following the meningitis outbreak at the New England Compounding Center in Framingham, Mass., Rep. Markey issued a report "Compounding Pharmacies, Compounding Risk" revealing that even before the current outbreak, problems at compounding pharmacies led to at least 23 deaths and 86 illnesses in 34 states, and that state regulatory bodies typically focus on more non-safety related traditional pharmacy licensing activities.
Rep. Markey then introduced his VALID Compounding Act to strengthen federal regulations for compounding pharmacies. He will soon reintroduce an updated version of that legislation.