Consumer Drug Report
The FDA deals with prescription drug shortages

The Food and Drug Administration (FDA) has had to face dealing with a growing number of prescription drug shortages caused by various reasons. The health regulating agency issued a consumer update on its website stating that possible reasons for the shortages may be caused by manufacturing or quality problems, delays, or discontinuations of the drug. When there is a drug shortage, the FDA works with the drug manufacturer to work out the issue and often asks generic drug makers to increase productions.

A letter of concern was issued to manufacturers in short supply of prescription drugs. The letter was issued on October 31, 2011 and stated that the number of drug shortages has nearly tripled within 5 years. In 2005, there were 61 drug shortages and that number increased to 178 in 2010. About 54% of these drugs shortages were caused by manufacturing problems and the FDA warns that these issues should be taken care of immediately so as to not jeopardize the patient’s health.

There are multiple reasons for drug shortages such as the following:

Interruptions or other adjustments in manufacturing

Delays in obtaining dire raw materials

Manufacturing complications causing supply disruptions

Import suspensions

Unforeseen rises in demand

Many of the drugs in short supply are used to treat life threating conditions such as cancer and anesthesia and are typically the only type on the market. This has raised much attention causing the Obama administration to get involved. An executive order by the Obama administration was also issued on October 31, 2011.The FDA has taken multiple approaches to dealing with the increase in drug shortages including issuing a letter of concern to the manufacturers of these critical drugs in short supply, increasing staff resources to avoid drug shortages, supporting legislation which will require manufacturers to report drug shortages, and much more.


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