This week the hopes for a less expensive, generic version of Oxycontin were shot down when the FDA made the announcement that the original version (withdrawn in 2010) was removed from the market for reasons of safety or efficacy. To quote the Federal Register exactly:
“The Food and Drug Administration (FDA) has determined that OXYCONTIN (oxycodone hydrochloride) extended-release tablets (10 milligrams (mg), 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg) approved under new drug application (NDA) 20-553 were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for products that reference NDA 20-553.”
That language is the proverbial stake through the heart of a generic opportunity. Of course, the manufacturers of Oxycontin couldn’t be more pleased, as their new crush-resistant tablet now appears to have patent protection up until 2025…a dozen years away.
As a pharmacist, this sort of news always brings conflicting emotions and concerns.
On The One Hand…
On the one hand, abuse of prescription medications is rampant in our society. Addressing this problem requires vigilance at many levels. I have no doubts that the technology used to deter the illicit use of Oxycontin is effective (though not perfect). And manufacturers that invest in such innovations (I’ve read it cost Purdue Pharma about 100 million dollars to do so) should be free to secure patent protection like anyone else.
On The Other Hand…
On the other hand, we are not so naive as to think this sort of thing is entirely altruistic. It is all-too-convenient for manufacturers to change their formulations just prior to patent expiration out of sudden concerns for “safety” (can anyone say Suboxone film?). It’s worth pointing out that Purdue Pharma markets both MS Contin and Dilaudid, both of which are subject to abuse, and neither of which have been “reformulated.” Not only that, but it raises the question that I pose in my title about the role of the FDA in general when it comes to drug approvals. Is it the job of the FDA to predict abuse potential and on that basis determine if a drug should be made available to the public? Apparently they think so. In a quote from FiercePharma:
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”
And it is not only Purdue Pharma that is helped by this decision. The Grunenthal Group, a German company whose anti-abuse technology is used by Purdue Pharma in the new Oxycontin formulation, has also made clear their excitement over the FDA decision. You can find their website and statement HERE. By the way, as a side-note, you might like to watch the cool little video about the abuse problem and their INTAC system to deter crushing click HERE (see video in lower left corner).
As A Pharmacist…
As a pharmacist I believe patients need access, through legitimate channels, to medications that are safe and effective. Both the FDA and DEA need to be aware of the abuse potential of medications and use appropriate measures to help ensure that neither the public, nor prescribers, are misled about the potential for addiction and abuse. I’m not unaware of the devastating impact that Oxycontin (sometimes called “Hillbilly Heroid“) abuse has on people and society. But I am not convinced that it is wise for the FDA to ban otherwise effective medications, especially those likely to be more affordable than current market options, simply out of fear of abuse. It would be like addressing the gun violence issue by requiring all ammunition manufacturers to make their bullets out of cotton candy. Softer. Sweeter. Albeit more likely to contribute to tooth decay. Oh well, no solution is perfect.
In 1962 an amendment to the Food and Drug Act was introduced called the Kefauver Harris Amendment. This legislation came about in response to the terrible Thalidomide tragedies which occured overseas and required manufacturers provide evidence of both Efficacy AND Safety prior to drug approval. This was good, common-sense legislation. But now it appears that “abuse-proof technology” may need to be added to the list of deal-breakers for drug manufacturers. I think we are going too far.
What do you think?
- Are you a pain patient that now must wait another 12 years for a less-costly generic to Oxycontin?
- Are you a physician that has to manage the very difficult job of prescribing for chronic pain?
- Are you a pharmacist (c’mon, I know you are out there!) who faces the reality of filling these prescriptions, not to mention the issues with respect to pharmacy robberies and threats?
- Are you a care giver to a chronically ill patient?
Please Comment! I would love to hear your thoughts below on this issue. Thanks for reading. Thanks for commenting. And enjoy your weekend!