In the wake of the ongoing scandal over a meningitis outbreak traced to a compounder, a Massachusetts congressman has introduced legislation that is designed to close alleged legal loopholes that prevented the FDA from taking swifter action. The Verifying Authority and Legality in Drug (VALID) Compounding Act would give the agency authority to oversee compounding pharmacies throughout the country, according to Congressman Ed Markey.
“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Markey says in a statement. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies."
The crisis emerged earlier this month and the New England Compounding Center, which is based in Framingham, Massachusetts, has been pointed to as the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states. The NECC was closed and an FDA inspection found numerous places where bacteria and mold were lurking in supposed 'clean rooms' used to store materials and prepare treatments (back story with FDA report and the latest from the FDA).
The legislation (which you can read here) is designed to address confusion over the role of the FDA, as well as state authorities, in regulating compounding pharmacies. The agency and others say court rulings have restricted its ability to respond unless a clear safety issue has been identified or a compounder engages in the equivalent of mass production and distribution that is more akin to the activities of a regular drugmaker. The NECC, for instance, engaged in such activity.
For this reaosn, others maintain the FDA already possessed the legal authority to pursue an enforcement action against NECC, which received an agency warning letter back in 2006 for various violations that raised concerns about its manufacturing and quality control procedures. Nonetheless, Markey does not want to take any chances and hopes that his legislation will strike the proverbial bi-partisan chord and become law.
Earlier this week, he also released a report purportedly showing that, since June 2001, the FDA attempted to "rein in the activities of dozens of pharmacies through the issuance of warning letters, all of which are publicly available... And that FDA records document 23 deaths and at least 86 serious illnesses or injuries associated with these practices" (here is the report).