The U.S. Food and Drug Administration (FDA) announced Thursday that it will be taking new action toward preventing drug shortages in an effort to combat the public health threat that arises when health care providers are unable to get the appropriate medications to patients in need.
According to FDA data, nearly half of all Americans take one prescription drug in any given month. And, while the number of medicines in short supply may seem small, they can be essential to the health of certain patients — especially critically ill ones.
The agency’s newly announced plan builds upon President Barack Obama’s 2011 Executive Order, which called for a reduction of drug shortages. In compliance with that order, the FDA was able to prevent 282 drug shortages in 2012. There were 117 drug shortages last year, down 251 from 2011. The FDA hopes to continue with its progress in stopping shortages by proposing a new rule and presenting a strategic plan to further address the problem.
“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,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.”
With that in mind, the agency presented a two-fold plan in hopes of building on its recent progress. First, the FDA is releasing a strategic plan that outlines the tools the agency has available to prevent and provide long-term solutions to drug shortages. In addition, the FDA has issued a proposed rule that would require manufacturers of “medically important” drugs to notify the agency of discontinuances or the possibility of interruptions of access.
"We cannot singlehandedly prevent all shortages: We can't force a private company to continue making a drug, and FDA does not have manufacturing ability to make the drugs ourselves," said Valerie Jensen, associate director of the FDA’s Drug Shortage Program.
The FDA intends to work with drug manufacturers and suppliers to investigate issues leading to interruption of access. The agency also hopes to speed up drug inspections and reviews of manufacturer submissions to avoid causing a shortage.
Another component of the plan involves opening the lines of communication between the FDA, manufacturers, health care providers, and patients. In a media briefing Thursday, the agency said that it is working to make the FDA’s website as useful as possible for resources concerning drug shortages. It is also working on an easily accessible smart phone application for patients.
"While we were happy to see a drop last year, we must work ever more diligently to make sure the trend continues in the right direction," said Jensen.