A deadly meningitis outbreak in October that led to the deaths of 36 Americans due to lax regulatory standards at a Massachusetts compounding pharmacy has prompted lawmakers in House of Representatives to introduce a bill imposing tighter regulations on the industry.
According to a press release issued by the two lawmakers who introduced the bill — Rep. Rosa DeLauro (D-Conn.) and Rep. Nita Lowey (D-NY) — the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act would require, among other things, drug compounders to register with a national Food and Drug Administration (FDA) database, patients to be informed whether or not they are receiving treatment with a compounded drug, a minimum level of FDA-sanctioned production standards for such drugs, and training opportunities for more vigorous state oversight of compounding pharmacies:
“I wish this legislation were not necessary, but recent, tragic events have proven that it is,” DeLauro said. “The actions of the New England Compounding Center have made clear that strong Federal authority is necessary to ensure patients know they are receiving safe compounded drugs. It has also become clear that federal and state regulators must better communicate to identify trouble facilities and leverage their resources to protect patients.”
“Yesterday’s announcement that multiple NECC products were contaminated simply underscore that this was not an isolated incident. We must end the current regulatory morass so that no more lives are placed at risk.”
Lowey said: “As recent events have made clear, it is critical to ensure compounding pharmacies are operating safely and the products consumers receive will improve – not jeopardize – their health. Federal oversight is critical to identify and correct potential problems and keep consumers safe.”
The congressional effort comes on the heels of Massachusetts separately cracking down on unregulated pharmacies in the state. After the initial outbreak, the FDA pleaded for Congress to set up clearer oversight standards on the compounding industry.