I recently read a USA Today article about unapproved drugs on the U.S. market and I was completely blown away by what I found out from it. It turns out that thousands of the drugs that doctors write prescriptions for each day are not approved for sale by the FDA. With all of the controversy and allegations surrounding FDA approved drugs like the recent troubles of Avandia and the colossal collapse of Vioxx a couple of years back, I was simply astonished that there are unapproved drugs being prescribed by unaware doctors, being filled by unaware pharmacists, and being bought by unaware consumers.
The FDA says that about two percent of the entire prescription dug market is accounted for by drugs that have never been approved. How is this possible? you may ask. Some of the unapproved drug manufacturers basically have been grandfathered in. See many of the these drugs were around before updates to FDA regulation required approval for drugs. This allows these drugs to be stay on the market with little attention from the administration. The FDA has made efforts to remove many drugs from the market but the sheer volume of unapproved medication makes it a difficult task.
Most recently, the FDA cracked down on unapproved products containing the antihistamine carbinoxamine. In June, the agency told their makers to seek approval or stop production by Sept. 7. FDA spokeswoman Susan Cruzan said Friday that all of the manufacturers had agreed to comply.
The FDA had received reports linking unapproved carbinoxamine products to 21 deaths of children under age 2. Labeling for the two approved products, Palgic and Carbinox Maleate, both made by Mikart, Inc., of Atlanta, says they’re not to be used in children under 2.
The makers of unapproved drugs argue that their product have stood the test of time and there for should not be required to go through the lengthy approval process. They also claim that small companies as many of them are could in no way afford the drug approval process. The agency does its best to concentrate its efforts on the drugs it see to be the most dangerous in order to make the greatest impact. Only time will tell if this mind-blowing flaw in the prescription drug market will be remedied but in the mean time it might be wise for consumers to look a little closer at just what they are taking.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.