Narco Non Victims

FDA Rapidly Removes Unapproved Drugs from Market

Many older drugs on the US market are unapproved by the FDA. For years these drugs have been assumed to be safe and effective and have been allowed by the FDA to remain on the market. However, recently safety issues have been raised for some of these unapproved drugs, especially because of a recent spate of child deaths purportedly caused by certain classes of these unapproved drugs. In the last couple of years FDA has been acting to remove some of the suspect unapproved drugs from the market.

As an example, in October of 2009 the U.S. Food and Drug Administration warned four companies that they must stop marketing unapproved codeine sulfate tablets. The four drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.

These particular products however have not received FDA approval and the agency has no evidence that they are safe and effective. Only one manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets.

Of interest to those marketing unapproved drugs is the rapid movement of FDA to remove the unapproved drugs from the market. Specifically, Roxane’s Codeine Sulfate Tablets were approved July 16, 2009; thus in just 3 months following Roxane’s approval for Codeine, the FDA has ordered all similar opioid analgesics off the market. What occured in this instance is that FDA very rapidly removed unapproved drugs from the market once the market was served by an approved drug, thus not disrupting the supply of these important pain medications by removing the unapproved drugs before an approved drug entered the market. However, once the market had an FDA approval for this class of drug, the FDA acted in three months to remove the unapproved drugs that were no longer required to serve the market.

The take home message here is:  Best for pharmaceutical companies to gain approval of their unapproved drugs now, instead of waiting for the FDA’s mandate to remove the drug, thus suddenly leaving the company with no drug on the market. The relatively rapid and inexpensive 505(b)(2) NDA process is an important mechanisms for gaining FDA approval of these drugs. Many small pharmaceutical companies currently marketing unapproved drugs will want to use the 505(b)(2) to gain FDA approval and avoid the likely sudden disruption of sales of their drug when FDA decides to remove a particular class of unapproved drug from the market.