Compounding Crises: Problems in America's Prescription Drug Supply
In 2012, stories of people who suffered severe illnesses or death after ingesting compounded drugs began to surface. Hundreds of people in nearly two dozen states were linked to a Massachusetts pharmacy that produced an injected steroid that contained a fungal contaminant. Unfortunately, due to a loophole in FDA regulations, oversight for compounded drugs is often lacking. Specifically, oversight is divided between federal and state regulatory entities. “Manufacturing” drug making is overseen by the FDA while “compounding” drug making falls under the authority of state pharmacy boards. Situations where FDA does have oversight include cases where:
- Large scale compounding is done in anticipation of receiving prescriptions but are not filled directly in response to actual scripts
- Compounding is intended for resale by third parties
- The compounded drugs are essentially the same as commercially available products
- The ingredients used in the compounded product are not formally approved by the FDA
In addition to the deaths of dozens of people infected by fungal meningitis, the compounding industry continues to face severe safety problems associated with contaminated drugs. For example, in 2014, compounded drugs made by Specialty Compounding were linked to at least 15 people with 2 deaths as a result of bacterial infection. Clearly, despite increased FDA oversight, the drug compounding industry continues to engage in manufacturing practices that endanger patients’ lives.
Origins of Compounded Drugs
While pharmacists have long engaged in the practice of compounding drugs, mass manufacturing of such drugs is a recent phenomenon. Many compounded drugs arise because a patient cannot receive an FDA-approved product and the practice is particularly popular for “bioidenticals” which is a class of drug that makers claim are “natural” alternatives to FDA-approved hormone-replacement products. These drugs are particularly popular because they do not require rigorous FDA testing and approval which means that patients can access them quickly and at a lower price than brand-name pharmaceuticals.
In other situations, compounders are sought when there is a shortage of traditional drugs. This is because compounders possess many of the same ingredients used to make brand-names. When shortages occur at hospitals and other health-care facilities, they often turn to compounders to meet patient needs.
Current Compounding Regulatory Landscape
In response to the tragic deaths caused by tainted supplies from the New England Compounding Center, Congress passed and President Obama signed H.R. 3204, the Drug Quality and Security Act in 2013. This bill aims to improve the process of drug compounding and enhance regulations by:
- Establishing annual registration requirements for outsourcing facilities
- Requiring the FDA to publish a list of drugs that are particularly likely to lead to adverse effects and pose high risks to patients
- Establishing requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain
- Establishing requirements for drug manufacturers, wholesalers, dispensers, and re-packagers to ensure that all prior transaction information is proved at each transfer of ownership
- Subjecting violations of the Act to criminal and civil penalties
If you or a loved one has suffered due to illnesses caused by compounded medication, call The Pittman Firm today. We can help you navigate the complex regulations governing this area of drug manufacturing and obtain compensation for your injuries.