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May 7, 2013 | Posted By Bruce D. White, DO, JD

The FDA has banned generic availability of the original formulation of OxyContin® (Purdue Pharma LP’s brand of oral controlled-release oxycodone). OxyContin® was approved by the FDA in 1995 and was first marketed in the US in 1996. Within a very short time, OxyContin® was the most frequently prescribed brand name analgesic with annual sales in the billions of dollars. By 2005 retail purchases were six times the 1997 volume; by 2008, sales totaled $2.5 billion.

Purdue was very effective in marketing OxyContin®. The manufacturer used several “sales strategies” that have since been roundly criticized by regulators and some physicians: aggressive off-label detailing; technically misbranding the product so as to mislead prescribers and patients regarding abuse potential; applying “significant political pressure” to gain state Medicaid formulary approvals; and engaging nationally recognized pain management thought leaders which “encouraged more liberal prescribing of opioids, based on debatable evidence.” With the increased prescribing, more of the drug was available for potential diversion to illegitimate channels. Not surprisingly, the number of accidental deaths from opioid drugs – licit and illicit – have grown in just a few years into a national crisis of epidemic proportions.

Very shortly after its introduction, law enforcement noted that narcotic abusers and addicts had found that they could crush OxyContin® and use the powder as a heroin substitute to snort (insufflate) or inject intravenously. “OC” (the street name derived from the imprint on the tablet to identify the product) became a more widely used as a drug-of-abuse because physicians could write prescriptions for OxyContin® and the valid prescriptions were relatively easily diverted from licit to illicit channels. “Pill mills” sprang up in a number of communities. Some have blamed Purdue for some of the problems associated with the easy availability of oxycodone as a street drug.

By 2005, several generic controlled-release oxycodone products formulated very similarly or the same as Purdue’s OxyContin® were widely marketed. These generic drugs were just as easily diverted to street use as OxyContin® had been. Moreover, Purdue itself manufactured some generic time-release oxycodone to be distributed by other drug companies, in effect adding to the competitive alternatives for its own brand name drug.

However, in 2011, Purdue Pharma reformulated its brand name time-release oxycodone line by using an “abuse-resistant” or “abuse-deterrence” polymer as an inert binder in the manufacturing process, principally designed to eliminate the recreational use via nasal inhalation option. (The re-formulated OxyContin® is imprinted with “OP” rather than “OC.”) Should one crush the new version of the tablet, it turns to liquid rather than powder. Unfortunately the possibility of injecting the product recreationally remains but with the much greater risk of severe symptoms of overdose, and death as compared to the oral route.

However, with the FDA banning the old formulation generic extended-release oxycodone – all for the best of reasons to prevent diversion and reduce the street availability of “hillbilly heroin” – it is ironic that Purdue Pharma LP may stand to benefit financially since its “abuse-resistant” reformulation may be the only alternative until its patent expires.

You can read about other recent articles on this topic here, here, and here.  You can read more at the Purdue Pharma LP Web site.

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.

1 comments | Topics: Beneficence, Distributive Justice, Drug Safety, Health Care Policy

Comments

Stephen Offord MD

Stephen Offord MD wrote on 05/20/13 9:44 PM

Bruce: Very topical. It seems we're (medical societies) are helpless without the FDA to meaningfully address prescription drug problems. Perhaps physicians are pain advocates first; or maybe many were clueless to the extent of the prescription drug problem; or maybe a relatively small number of practitioners prescribed a high proportion of drugs for illicit use. But if physicians want freedom from government oversight they ought to speak up sooner and louder about problems they are a part of.

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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.
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