The Food and Drug Administration has a long history of protecting Americans from dangerous substances. Or, as the organization says on its website:
The FDA is responsible for
- Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
- Protecting the public from electronic product radiation
- Assuring cosmetics and dietary supplements are safe and properly labeled
- Regulating tobacco products
- Advancing the public health by helping to speed product innovations
- Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health
That explains why the organization banned nine pharmaceutical companies from selling “illegal, unapproved pain drugs” three years ago.
It looks as though one problem was that high concentrate morphine sulfate oral solutions, hydromorphone and oxycodone, had not yet been approved. (Generic oxycodone was only approved in April 2010, two years ago.)
Boehringer was one of the companies selling the “delightfuly named” drug Roxicodone, which “… is yet another version of hillbilly heroin oxycodone, or OxyContin,” according to the article. As Joan reminded me, this is the drug that Joey Rovero died of, after which his mother April Rovero started the non-profit National Coalition Against Prescription Drug Abuse.
What is insidious about Roxicodone is that it’s so potent. However, I’m not sure why the CBS News article quoted BNET as saying it was an oversight on the company’s part. Selling it before it was approved was an oversight?
Interestingly, here is the warning letter the FDA sent to Boehringer that granted an extension for manufacturing/distributing it because “those in the pain management community” said the removal would impose extreme hardship on palliative care patients and their communities.
It seems that this organization tries to take patients’ needs into consideration as well.
But note that once again – this month, in fact -- the FDA has cracked down on non-approved Oxycodone. The Mississippi TV station WJTV, which published the news, offers a reminder that “the best way to make sure that a drug is FDA-approved is to buy it at a pharmacy.”
Other important news about OxyContin is that Purdue has asked the FDA to approve the use of this drug for children as young as 6. Currently, the company is conducting a clinical trial (one of the requisites for being granted approval) to document what happens when children take it.
Alarm bells are undoubtedly screeching in the addiction and recovery community since OxyContin has been so easily abused. The company has “admitted in court that it misled doctors and the public about OxyContin’s risk of addiction. The company and three top company executives, each charged with a felony, paid $635 million in fines.” No one wants to see children in pain, but do we really need to start people on this medication at an early age?
Skeptics are pointing to the company’s motives since a patent for the company’s original formulation expires in 2013. Selling OxyContin for pediatric pain management would open a whole new market for the drug and help Purdue’s bottom line.