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FDA RULING WILL AFFECT THE FUTURE OF PRESCRIPTION DRUG ABUSE

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FDA RULING WILL AFFECT THE FUTURE OF PRESCRIPTION DRUG ABUSE

It is no secret that illegal drug abuse is not the only type of drug abuse plaguing our country, but the extent of it might surprise you.  Painkiller abuse is responsible for killing more people than all illegal drug abuse combined.  For a long time, the most abused prescription painkiller was Oxycontin.  Due to its old time-release formulation, each pill had a much higher concentration, therefore abusers could crush the pills and the entire dose would be delivered at once, resulting in an intense high.  But progress has been made.  Branded drug manufacturers Endo Health Solutions and Purdue Pharmaceuticals invested a great deal in creating a tamper resistant pill that was almost impossible to crush and consume illegally.  According to studies funded by the companies, this change was worth it, resulting in a downward trend in abuse of Oxycontin.  That progress has now been threatened.

Generic manufacturers want to manufacture and market the old version of Oxycontin, which Endo and Purdue claim will not only negate the investment they made in the new formulation, but will also revive abuse of the dangerous drug.

The FDA will have to decide if it will grant the generic manufacturers the permission they are seeking, or if they will side with the branded manufacturers and block it.

The Generic Pharmaceutical Association warns the FDA against rewarding Endo and Purdue’s apparent altruism.  It claims that the companies are not motivated by concern over prescription drug abuse, but only by the financial stakes they have in the game, evidenced by the fact that they only released the new formulation after the old one’s patent was about to expire.  They also argue that if the FDA did block the generic manufacture of the old formulation of Oxycontin, then generic manufacturers wouldn’t be able to produce anything at all, since the new tamper-resistant formulas are on patent right now.

The United States isn’t the only one struggling with this issue.  In Canada, a recent ruling inspired outrage when the federal health minister granted approval to six generic versions of OxyContin.  Canadians are concerned that the cheap generics will flood the streets and they will see an uptick in deaths from the drug.  Americans are concerned that easy access to cheap generics will cause them to trickle over the border, increasing abuse in this country no matter what happens with our own controversy.  The Drug Enforcement Agency has been alerted to this possibility and prepares to deal with it.

What do you think?  Will there really be an increase in prescription drug abuse if the generic version of Oxy comes available, or is it just another way that brand name drug manufacturers are trying to keep ahold on the market?

Sources and Further Reading:

http://online.wsj.com/article/SB10001424127887323717004578159661903540402.html?mod=googlenews_wsj

http://online.wsj.com/article/SB10001424127887323717004578159661903540402.html?mod=googlenews_wsj