Lawmakers Considering Increased FDA Authority over Compounded Drugs


June 08, 2013

While the Food and Drug Administration (FDA) generally oversees and regulates drug safety for consumers, the outbreak of fungal meningitis last year exposed a weakness in our drug safety protocols for compounded drugs.  The term “compounded drugs” refers to multiple drugs that have been mixed together to provide a specific formulation for the benefit of particular patient that is not yet available or approved by the FDA.  In the wake of this health crisis, Congressional committees have advanced two separate bills that would grant the FDA more authority over compounded medications.

The proposed changes follow an outbreak of fungal meningitis that was linked to fifty fatalities and hundreds more suffering from the illness.  The investigation that followed the outbreak identified four dozen compounding drug companies that were either mixed in unsafe conditions or produced contaminated drugs. 

A report out of the Senate justifies the proposed legislation indicating, “[I]n 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.

Federal lawmakers are now calling for a comprehensive regulatory scheme under the authority of the FDA to replace the current licensing system for drug compounding companies that would replace the current state law regulatory framework.  The report indicates that tougher federal regulations are important because of the wide range of shortcomings in the fungal meningitis outbreak caused by Massachusetts-based New England Compounding Center (NECC).  The nature of the deficiencies that allegedly contributed to the outbreak includes the following:

  • Failure of the compounding company to implement adequate quality control measures
  • Failure of the state regulatory agency to revoke the company’s license despite multiple compliance issues
  • Inaction and supervision by the FDA as well as lack of appropriate warnings to the public
  •  Congressional inaction on the issue after identifying the problem more than ten years ago

The proposed legislation, the Pharmaceutical Compounding Quality and Accountability Act, S. 959 would distinguish traditional drug compounding that would continue to be regulated by individual states while those that are sold across state lines would be regulated by the FDA under standardized national policies and procedures. 

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