November 9, 2012 | Posted By Bruce White, PhD

Almost everyone now must have heard about the New England Compounding Pharmacy tragedy that has been unfolding over the past month. The Centers for Disease Control and Prevention in Atlanta (CDC) numbers the present death toll at 28 and total reported cases at 377 from 19 states. Untold thousands of patients may have been injected with contaminated medicines. The New York Times has called this situation “one of the worst public health drug disasters since the 1930s.” 

Already there are more calls for stricter regulations and controls for compounded medicines that enter interstate commerce. The New York Times reported on November 2, 2012, that Representative Edward J. Markey (D-Mass.) will be introducing a bill to oversee compounding pharmacies with wide-scale operations be regulated as “manufacturers” by the Food and Drug Administration (FDA). Calls for greater regulation of compounding pharmacies are not new; the FDA has been attempting greater control for at least the last 20 years.

However, the real question remains: would federal oversight have made any difference? Some may think that federal government regulation rather than state government regulation may have prevented this unfortunate episode. Federal oversight – to the amazement of some – may have made little difference. There are certainly not enough FDA inspectors at the present time to make periodic visits to the registered manufacturers facilities. Moreover, if this situation turns on ordinary negligence – someone or some persons at the pharmacy failing to meet the standard of care – the number of applicable regulations will have made little difference, right? Really, isn’t it common sense that a “sterile product” be sterile and free of bacterial or fungal contamination? If a purported sterile product – whether manufactured or compounded – is not sterile, the medicine is failing to meet labeled standards, period.

Moreover, federal regulations – if crafted for compounding pharmacies specifically – would probably not be that dissimilar from what is now prescribed by state boards of pharmacy. State regulation can be just as extensive and rigorous as federal regulation, in some cases far more strict.

Perhaps the question then is not whether or not the federal versus the state regulators may do a “better” job of enforcing clear standards? Perhaps the question is whether or not either or both is more suited or more situated? If the product passes from state to state in interstate commerce, it does seem reasonable that one federal standard be created to avoid unnecessary duplication or inefficiency. However, federal oversight does not – in itself – guarantee appropriate oversight since federal regulators are at the funding mercy of the Congress for management and staffing. The FDA is rarely cited as an example of a federal agency that is well managed and staffed with appropriate numbers of experts and investigators to carry out their mission effectively.

Regardless of which agency – the FDA at the federal level or the state boards of pharmacy at the state level, or both – may be responsible for monitoring compounding pharmacies, if there is a severe crackdown, some medicines that are difficult to procure now will become even more scarce. One of the reasons that practitioners are turning to compounding pharmacies at all for pharmaceuticals is because some products – including sterile generic products such as methylprednisolone and triamcinolone injectables for chronic pain – is because commercial suppliers have ceased to manufacture products with little commercial return. Without government action to support these non-profitable and dwindling supply lines, the shortages are only going to get worse.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

0 comments | Topics: Bioethics and the Law , Distributive Justice , Health Care Policy , Malpractice , Negligence

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.