FDA pushes rules to combat drug shortages

The Obama administration on Thursday proposed regulations that would require drug companies to warn the government about disruptions in supply.  

The draft Food and Drug Administration (FDA) regulations impose new requirements on pharmaceutical companies, and was released along with a strategic plan to combat prescription drug shortages.  


The FDA said the measures will assure patients who need drugs to fight cancer and other debilitating diseases that their medicine will be ready for them.

“The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” Janet Woodcock, the director of the FDA’s drug evaluation center, said in a statement.

Drug shortages have long been a problem for federal officials, and can be caused by manufacturing outages, delays and other problems.

According to the FDA, the number of drug and medical product shortages quadrupled from 2005 to 2011, when there were more than 250 cases.

That number ticked down to 117 in 2012, after President Obama signed an executive order telling the agency to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.”

Nonetheless, the agency said that shortages “still represent an ongoing challenge to public health.”

The rules will “improve FDA's ability to identify potential drug shortages and to prevent or mitigate the impact of these shortages,” the FDA said.

The proposal would require drug manufacturers to tell the FDA if they plan to discontinue making drugs or expect a major interruption in their production that would disrupt the supply.

Drug companies will be required to give federal officials six months’ warning, if possible. Federal officials will then try and work with other manufacturers to produce the pharmaceuticals.