The FDA and The Abuse Deterrent Draft Guidelines:
What Is Really At Stake Here For Elite???
Some Things To Consider:
1) Purdue's Oxycontin Patent is set to expire in 3 short months. So What? Would seem like a good thing right. I mean Purdue has made enough money off lying, cheating, and stealing.
2) The potential problem is that because the FDA, not surprisingly, has drug its feet on deciding whether or not generic versions of easily abusable drugs will have to carry abuse deterrent technology...we could easily see oxycodone abuse run rampant again as easy crushable generic versions flood the market.
3) I mean look what happened with Endo and Opana after their patent expired. Impax started shipping a easily abusable generic version Jan. 1 2013. Further, Novartis, Watson, Actavis, Teva, and Ranbaxy have all challenged Endo's patent. Actavis already has a non tamper resistant version on the market as well.
4) Not Surprisingly, as well, state and federal lawmakers are worried about this very problem and pushing for tighter controls on generic drugs wanting the FDA to require generic opioids to have abuse deterrent properties. Thus, the Bill in Kentucky that would prohibit substituting a non-abuse-resistant generic. Further, the STOPP ACT which would require new opioid drug applications to be tamper-resistant drugs or carry those properties.
5) On the other side, you have rather large lobbying interests of generic pharmaceutical companies and associations who oppose requiring generics to have abuse deterrent properties stating the majority of pain medication is used properly by non addicts. The other argument is that generic drugs without abuse deterrent properties cost vastly less than generics that would use them thus costing patients to pay a much higher price to get generic pain meds.
6) Wouldn't you know it Purdue has publicly come out in support of the STOPP ACT though I would argue rightly so for financialgain than anything else. Got to hate when you are on the same side of the fence as Purdue.....but Elite is on that side of the fence.
7) Here's the thing if generic drug companies are forced to come up with their own abuse resistant formulations it would significantly increase their revenue related to research and design. Many such companies would need years and years to develop this technology and would just assume come to a company like Elite to license this technology. At this point, Elite isn't a Pfizer or a Watson and because of it's financial problems would likely be willing to license their Abuse Resistant Technology for a reasonable price.
8) You can see that the FDA is getting pressure placed on it to require generic opioids to entail abuse resistant properties. The draft guidelines for Abuse Deterrent opioids is a first step in that direction. By the time the FDA moves towards this requirement and IMO it will....Elite will already have abuse resistant versions of many generic opioids already on the market!!!
*****My Point......Elite is already in the midst of the perfect storm and its Abuse Resistant Technology is a Game Changer....that much I am sure of!
