The FDA recently made an announcement on withdrawing specific oxycodone formulations. The press release from the FDA that the major media responded to appeared to be a proactive action by the FDA. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310641.htm
However, a review of the twelve page announcement in the Federal Register exhibits the incredible incompetency that prevails at the FDA concerning the prescription narcotics. http://www.ofr.gov/OFRUpload/OFRData/2012-16475_PI.pdf
If people were not dying from the intransigent attitude the FDA has about the free distribution of the legal narcotics, the announcement in the Federal Register would keep The Daily Show and The Colbert Report on Comedy Central with material for a number of shows.
The FDA announcement simply indicates that products that do not have the proper labeling and warnings as part of their marketing and selling need to be taken off of the market. In other words, the announcement doesn’t have anything to do with limiting the use of oxycodone. It is just a bigger bonanza for the oxycodone producers that are playing by the FDA rules.
OxyCodone is oxycodone no matter how it is labeled!
SELECTED SENTENCES FROM THE FEDERAL REGISTER ANNOUNCEMENT:
- Unapproved oxycodone drug products have been implicated in reports of medication errors causing serious adverse events.
- Unapproved new drug products containing oxycodone pose particular safety concerns because of their potential for addiction.
- FDA has received reports of medication errors associated with unapproved oxycodone products and the strength of the active ingredient.
- FDA has reviewed the publicly available scientific literature for unapproved single ingredient, immediate-release drug products containing oxycodone for oral administration and labeled for human use. In no case did FDA find literature sufficient to support a determination that any of these products is generally recognized as safe and effective.
If the FDA needs help searching for adverse effects concerning “approved” oxycodone products, I suggest http://www.banoxycontin.com As of this writing, almost 11,700 signatures and thousands of comments concerning the “safe and effective” use of OxyContin.
Do we laugh or cry this week concerning the FDA’s actions?