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Wednesday, September 26, 2007

FDA Drops The Ball For Forty Years

Something I read today was difficult to believe. When a new drug is submitted to the FDA they assign it a 10-digit number to keep track of it as it goes through the testing process. For reasons only know to the FDA, they do not assign the drugs a different type of designation if/when the drug is approved. This means that as soon as a drug company submits a new drug, they have the code that will be used by pharmacies to order the drug. Whether the FDA had conducted a single test on the drug, pharmacies can order it. To the pharmacy and the physician, nothing out of the ordinary seems to occur, unapproved drugs have the same coding as unapproved drugs. Apparently this has been a know loophole for the last four decades. To draw attention to healthcare providers, all the FDA had to do was change their coding system. Maybe that would be a pain in the ass, but they had quite some time to sort it out. Now the FDA refuses to make public the list of unapproved drugs that have received a number, so we as regular individuals don't have a way to check if the drugs we are prescribed have actually been tested. It's estimated that 2% of prescriptions written are for unapproved drugs. That means that one out of every fifty is unapproved and untested. A recent arrestee who had marketed unapproved drugs was shocked by his arrest stating that the FDA had turned a blind eye to the loophole for so long, it was pretty much SOP. I already have lots of reasons to mistrust the FDA, I suppose I'll have to add wild incompetence to the list.