FDA Should Inspect Previously Warned Compounding Pharmacies

Representing Orlando, Tampa, Miami and Nearby Areas of Florida

Colling Gilbert Wright & Carter represent nearly 40 clients injected with tainted steroids from New England Compounding Center (NECC) which have been implicated in the nationwide outbreak of fungal meningitis. We have previously noted on this blog that those contaminated steroids are also causing epidural abscesses, fungal bone infections (osteomyelitis), and other serious complications. This tragic outbreak of illness has been blamed on the filthy conditions at the NECC facility, which led to the contamination of what should have been sterile pharmaceutical products. However, as we have noted previously on this blog, NECC appears to have been acting outside the legal parameters of what compounding pharmacies are permitted to do. Specifically, it appears that NECC was producing and distributing large amounts of particular drugs without an individual patient prescription. Such practices cross over the threshhold of “compounding”, and begin to seem more like the actions of a pharmaceutical manufacturer. This has brought up important questions about regulation, or the seeming lack of regulation, of the compounding industry. The FDA has consistently argued that their hands are tied, saying that they do not have the authority to regulate compounding pharmacies without new legislation being crafted to grant them that authority.

We agree that work needs to be done to clarify the regulatory landscape, to avoid future tragedies like the curent fungal meningitis outbreak. However, we strongly agree (as we often do) with the folks at Public Citizen on this subject. Public Citizen has sent a letter to the FDA, calling on them to re-inspect the 16 compounding pharmacies that received warning letters from the FDA between 2003 and 2012. 18 such warning letters went out in that span of time, several times making note of injuries or deaths associated with the products distributed by the compounding pharmacies in question. In light of the recent fungal meningitis outbreak, Public Citizen is urging the FDA to re-inspect the facilities that received those warning letters.  Public Citizen’s letter also questions the FDA’s insistence that they are not authorized to regulate compounding pharmacies. In Public Citizen’s letter to the FDA, Dr. Michael Carone writes:

“The FDA’s warning letters show that the agency doesn’t need any additional actions by Congress to enforce the Food, Drug, and Cosmetics Act against pharmacies that engage in illegal drug manufacturing… By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens.”

Now is not the time for finger-pointing, but with nearly 40 people dead and more than five hundred suffering from serious illnesses, it is obviously time for urgent corrective measures to be taken. NECC will eventually be held accountable for whatever part they played in the manufacture and distribution of contaminated drugs. However, the lesson here seems to be that more stringent oversight of compounding pharmacies is needed to avoid similar tragedies in the future. We wholeheartedly support Public Citizen’s recommendation to the FDA. If sixteen compounding pharmacies have received warning letters in the past 9 years for violations similar to those of NECC, it is urgent that the FDA re-inspect those facilities now to pre-empt any further catastrophes. Many of the stories about recent years at NECC spark a realization that if only something had been done in 2004, or 2006, all of this tragic illness and death could have been avoided. There are 16 compounding pharmacies in the country who have a similar history to NECC, of being warned by the FDA in recent years. Any one of those 16 facilities could be the source of the next avoidable outbreak of disease, if they are persisting in behaving as unregulated pharmaceutical manufacturers as NECC did. The FDA should inspect those compounding centers immediately to protect the public health. Finger-pointing and excuses can wait for another day.