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On Nov. 27, 2013, President Barack Obama signed into law the Drug Quality and Security Act of 2013 (DQSA). A key part of this new law is intended to prevent another horrifying disease outbreak from tainted compounded drugs, like the one in 2012 that caused 751 patients to become sick with fungal meningitis and other infections, killing 64.
Public Citizen opposed the passage of the DQSA primarily because it creates a new category of companies, called “outsourcing facilities,” that are...
On Nov. 27, 2013, President Barack Obama signed into law the Drug Quality and Security Act of 2013 (DQSA). A key part of this new law is intended to prevent another horrifying disease outbreak from tainted compounded drugs, like the one in 2012 that caused 751 patients to become sick with fungal meningitis and other infections, killing 64.
Public Citizen opposed the passage of the DQSA primarily because it creates a new category of companies, called “outsourcing facilities,” that are allowed to mass-produce standardized drug products without seeking FDA pre-market approval. This kind of large-scale production is not compounding; it is drug manufacturing, and it was illegal prior to passage of the DQSA. Legalizing a second-tier, substandard class of drug manufacturers represents a substantial step backward for drug safety.
Following enactment of the DQSA, the Food and Drug Administration (FDA) began to rapidly implement the new law. Because the law makes registration as an outsourcing facility voluntary, the agency is seeking to use market forces to drive large-scale sterile drug compounders to register as outsourcing facilities. To that end, in early December, FDA Commissioner Margaret Hamburg and other agency officials issued public announcements encouraging hospitals and other medical facilities to purchase compounded drugs only from registered outsourcing facilities.
On Dec. 17, 2013, we wrote a letter to the FDA criticizing these announcements because they gave the false impression that drugs made by outsourcing facilities will now be subject to the same federal oversight as FDA-approved drugs, which will in turn lead health care providers to purchase and prescribe the products as substitutes for FDA-approved products. All compounded products are fundamentally riskier than FDA-approved products. They are not assessed by the agency for safety and efficacy prior to marketing, and their labels need not contain adequate directions for use.
Fortunately, the FDA acted: On Jan. 8, 2014, Commissioner Hamburg sent a letter to thousands of hospitals and health care facilities encouraging them to require facilities from which they purchase compounded sterile drugs to register with the FDA as outsourcing facilities. Her letter noted the following:
When a drug is FDA-approved, patients are assured that FDA has reviewed the safety and efficacy of the drug and the adequacy of the manufacturing process to produce a quality product. Because they do not go through the drug approval process, compounded drugs do not provide such assurance and, therefore, should only be used when an FDA-approved product is not available to meet the medical needs of an individual patient.
The FDA must repeatedly reiterate this message and educate physicians on the risks associated with treating patients with compounded drugs.
