State and federal regulators are scrambling to shift blame for the nationwide meningitis outbreak linked to tainted steroid injections, even though it was their own respective failures to act in the public interest that are ultimately responsible for this ongoing tragedy. Though these government agencies would have us all believe that they lacked the power and authority to stop the New England Compounding Pharmacy (NECC) from basically operating as an illegal drug manufacturer, the truth of the matter is that these entities did nothing to stop the company from violating the law for many years.
A recent Washington Post piece clearly illustrates the complete lack of integrity and responsibility among our nation’s regulatory agencies when it comes to protecting the public against companies like NECC, which appears to have been actively flouting the law for years without consequence. And whenever a tragedy of the magnitude observed in the meningitis outbreak occurs as a result of such regulatory failure, the agencies responsible immediately begin complaining about how they did not have enough resources, enough manpower, enough legal authority — whichever excuse will shift blame the fastest is typically the one that is used.
The U.S. Food and Drug Administration (FDA), for instance, which should have been actively addressing the problems it first discovered back in 2006 at the NECC facility, instead chose to do nothing. And now that at least 15 people have died and another 205 infected with deadly fungal meningitis, the FDA is whining like a baby about how it needs more power and authority to do its job. This is utter nonsense, of course, as the FDA already has more than enough power to address the types of problems it found at NECC.
“They have all the regulatory authority they need,” said Peter Barton Hutt, a former FDA chief counsel, in response to FDA complaints that a new “regulatory scheme” is needed to control these types of risks. “[The agency] couldn’t ask for any more. What they need are better resources and better coordination.”
FDA spinning its own regulatory failures to attack compounding pharmacies
The way this entire scenario seems to be playing out is that compounding pharmacies, which generally operate very safely with individual patient needs as a top priority, are now taking the collected blame for the FDA’s regulatory oversight. Even though this is patently false, the FDA is now insinuating, like it routinely does when there are problems with specific dietary supplement companies, that the NECC issue points to the need for more control over compounding pharmacies.
Truth be told, compounding pharmacies are already heavily regulated, primarily by the state governments of the states in which they operate. Most compounding pharmacies are local, as their purpose is to custom-craft medicines for individuals based on personalized needs, which is typically far more effective in actually alleviating symptoms and curing disease than the one-size-fits-all corporate model embraced by the pharmaceutical industry.
Unlike real compounding pharmacies, NECC was allegedly manufacturing its own drugs in the same way that major drug companies do, which is not typically what compounding pharmacies do, and distributing them across the country. The company was also allegedly repackaging and selling existing drugs, which is just a general violation of the law that has nothing to do with the specific practice of compounding.
Nevertheless, the FDA is trying to spin the issue and make it one about a nonexistent lack of authority over compounding pharmacies, as if compounding is somehow the issue here. The real issue, as will hopefully be clearly evident to the public, is the FDA’s selective enforcement tendencies, lack of proper followup, and general disregard for the proper execution of its existing responsibilities, which in this case facilitated the distribution of deadly drugs.
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