The Food and Drug Administration announced the steps it is taking to end the shortage of two important cancer drugs.
To avert an impending shortage of methotrexate, a drug used to treat children with leukemia, the FDA has worked with manufacturers to help ramp up production and has approved a new application to produce the version of the drug that is most needed, which will further bolster supply and ensure patients have access to this lifesaving medicine.
To end the shortage of the cancer drug Doxil, the FDA will allow the temporary importation of a replacement drug. This action should address patient needs and end this drug shortage.
On October 31, 2011, President Barack Obama signed an executive order directing the FDA to take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging.
Since President Obama signed his executive order, FDA has prevented 114 drug shortages, according to a statement released by the administration, which said, “In part, this (prevention) resulted from the administration’s call for voluntarily notification to the FDA of potential shortages. Notification of a potential shortage is crucial: with enough advance warning, FDA can take action to help stop a potential drug shortage. And since President Obama signed his executive order, voluntary notifications have increased six-fold.”
In an interview with Healthcare Finance News in November, Steven Lucio, director of clinical solutions, pharmacy, at Irving, Texas-based healthcare supply contracting firm Novation, said the president’s executive order is “very helpful” in the fight against drug supply disruptions.
“The executive order points out several things. It addresses expectations of the supplier community and also for the FDA itself,” said Luccio. “Everyone has a role to play. The (pharmaceutical) supply chain is very complex.”
Luccio also sees a glimmer of hope in the improved communications between the FDA and manufacturers.
“The FDA has said drug companies are doing a better job of giving them advance notice of a shortage,” said Luccio. “As bad as it’s been, we can at least minimize the impact. With improved communication, I expect things to improve.”
Follow HFN Editor Rene Letourneau on Twitter @ReneLetourneau.