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Harkin, Alexander, Roberts, Franken Release Report Outlining Urgent Need for Clear Regulatory Guidelines of Drug Compounders as Committee Approves Legislation

Bipartisan Report Finds That Public Health Risks from Large-Scale Drug Compounding Persist; Fall 2012 Fungal Meningitis Outbreak Stemming From the New England Compounding Center’s Tainted Steroid Injections Sickened More than 700 and Killed More Than 50

Since Last Fall’s Meningitis Outbreak, at Least 48 Large-Scale Compounders Have Produced and Sold Drugs That Were Contaminated or Created in Unsafe Conditions

“Pharmaceutical Compounding Quality and Accountability Act” Would Clarify FDA Authority Over Compounding Manufacturers, Improve Safety of Compounded Medications

WASHINGTON, D.C.— Today, as the HELP Committee approved the Pharmaceutical Compounding Quality and Accountability Act—legislation that would improve the safety of compounded human drugs by making clear the compounding oversight responsibilities of state and federal authorities—Senators Tom Harkin (D-IA), Lamar Alexander (R-TN), Pat Roberts (R-KS), and Al Franken (D-MN) released a U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee staff report outlining the urgent need for a clear statutory framework to ensure the safety of compounded drugs for consumers. Harkin and Alexander are the Chairman and the Ranking Member, respectively, of the HELP Committee.

The Committee report finds that large-scale drug compounders, which are currently regulated similarly to state-licensed community pharmacies, continue to pose a serious risk to public health. 

In the eight months since the NECC-linked meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions. 

  • In at least 3 cases, visible contamination was spotted in widely distributed sterile compound drugs.
  • Ten drug compounders have issued national recalls of compounded drugs because of concerns about contamination; and
  • Eleven drug compounders have been ordered by state licensing agencies to stop producing some or all drugs.

The Pharmaceutical Compounding Quality and Accountability Act, which the HELP Committee will vote on at an executive session on May 22, 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 U.S. Food and Drug Administration (FDA). It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.

The HELP Committee’s work on legislation to improve the safety of compounded drugs came in response to a fall 2012 fungal meningitis outbreak that sickened more than 700 and led to the deaths of more than 50 individuals. The meningitis outbreak was directly traced to contamination in steroid injections produced at a large-scale compounder, the Massachusetts-based New England Compounding Center (NECC).

“This bipartisan report reveals that subpar quality and safety standards that were present at the New England Compounding Center continue to exist at other large-scale compounders, posing a grave threat to public health,” Chairman Harkin said. “The fungal meningitis outbreak linked to the NECC sickened more than 700 individuals and led to the deaths of another 50. The Pharmaceutical Compounding Quality and Accountability Act will help protect the public from unsafe compounded products and clarify FDA authority over high-risk compounding practices. Congress must take action to improve the safety of compounded drugs and prevent the next public health crisis, and that is exactly what our legislation would do.”

Alexander said, “Our bill makes it absolutely clear who is charge of overseeing these compounding businesses, and this report confirms that the tragic meningitis outbreak came on the heels of many reports about dangerous practices at poorly regulated large-scale compounders, and will happen again if we do not clarify oversight.”

“This report details a shocking failure to act. A failure to act by NECC to protect their patients. A failure by MA Board of Pharmacy to pull the license of an entity with repeated compliance issues. A failure to act by the FDA to see beyond the bureaucracy and red tape that defines them, to use the authority they had or share the information they were in possession of to protect patients and the public health. A failure to act by Congress who has recognized the lack of clarity on these issues since over a decade ago and could have potentially averted this crisis,” Roberts said. “I've been working with Members like Senator Burr for years to gain momentum on these issues, and through the leadership of Chairman Harkin, Ranking Member Alexander and Senator Franken we are putting forth legislation to address these failures and ensure clarity in the future to avoid another crisis and put patients first.”

“This report confirms that we need to take immediate action to make sure that patients are not becoming ill or dying because the medicine they’ve taken was contaminated,” said Sen. Franken. “The bipartisan legislation I’ve worked on with my colleagues is a commonsense fix that will help protect patients from future harm. It’s critical that we pass it as soon as possible.”

Additional report findings include:

  • Sampling of compounded drugs by the FDA in 2001 and 2006 demonstrated that thirty-four and thirty-three percent of the drugs sampled Between 2001 and 2011, FDA documents indicate that at least 25 deaths and 36 serious injuries, including hospitalizations, were linked to large-scale drug compounding companies, including 13 deaths in 2011 alone.  These numbers likely understate the actual number of adverse events, as current law does not require reporting of these events.
  • A separate accounting of adverse events and complaints linked to drug compounding companies between 1988 and 2005 documents at least 38 deaths—including six infants or children—and 210 injuries from drugs that were contaminated, mislabeled or caused lethal overdoses because they contained more of the active pharmaceutical ingredient than indicated.
  • The New England Compounding Center and the co-owned compounding company, Ameridose, both have lengthy track records of producing drugs of questionable sterility and potency, and both were the subject of repeated adverse event reports and consumer complaints.
    • Between 2002 and 2012, NECC was the subject of at least 52 adverse event reports exemplifying the dangers created by its hazardous compounding practices, with documented issues including: the failure to ensure the sterility of equipment and products, the distribution of drugs containing particulate matter; the manufacture of superpotent and subpotent drugs; the mislabeling of drugs; inaccurate beyond use dating; and the illegal distribution of drugs in the absence of patient-specific prescriptions.
    • Between 2007 and 2012, Ameridose was the subject of at least 18 adverse event reports, and inspections show that drugs compounded by Ameridose were documented to have issues relating to sterility, potency, mislabeling, and adulteration.

The Committee report concludes that “in order to reduce the risk to the public health from compounded drug products, it is essential that a clear statutory framework be enacted that requires compounding manufacturers to engage in good manufacturing practices, to better ensure the drugs produced are sterile, and contain the correct amount of the active pharmaceutical ingredient.”

This is the second HELP Committee staff report of the Committee’s investigation into the nationwide outbreak of fungal meningitis traced to injections of contaminated drugs prepared by the Massachusetts-based New England Compounding Center.  The report is based on a review of more than 30,000 pages of internal FDA documents over a six-month period, as well as publicly-available documents.

The full text of the report can be seen here.