Shevlin Smith Blog

FDA acknowledges loophole that allows non-FDA approved drugs to be prescribed by health care providers

CNN reports that doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs. These drugs slip through a "black hole" in the drug approval system, whereby the FDA provides the drugs with an identification number to track the drug the regulatory process but that identification number is then used by pharmacies and health care providers to order the drugs for patient use. Because the drugs have an identification number, pharmacies and health care providers mistakenly believe the drugs have been approved by the FDA even though they have not. According to the CNN article, the FDA has known about the existence of this "black hole" for over four decades, but has failed to address it. Perhaps even more shocking, the FDA refuses to identify for the public the drugs that have slipped into this "black hole" despite knowing the identity of such drugs. The result is that the public continues to be at risk. Click here to read the CNN article in full.