As we have noted over the past several months, drug shortages have been causing severe problems for patients in America. Drug shortages almost tripled to 178 in 2010 from 61 in 2005, according to an FDA report released in October. Sterile injectables account for 80 percent of the shortages the FDA studied, 28 percent of which were cancer drugs.
Before Obama’s executive order, FDA received an average of 10 monthly notifications of potential drug shortages from January 2011 to October 2011, according to the FDA. The number jumped to 60 from November to April. Manufacturing was the main reason in 43 percent of the cases reported to the FDA for shortages, the agency said.
In response to these challenges, the Food and Drug Administration (FDA) and President Obama took unprecedented action. It has been six months since those steps were taken, and FDA Commissioner Margaret Hamburg, M.D., recently gave the public a “Six Month Check-Up on FDA’s Work on Drug Shortages.”
She noted that six months after FDA began taking actions and President Obama issued an Executive Order regarding drug shortages, FDA has been able to prevent 128 drug shortages, and FDA is seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year.
“I am both amazed and delighted to see the progress that’s been made,” Hamburg said. “Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts.”
Importantly, particular improvements have been seen for drugs that treat life-threatening diseases. For instance, supplies of methotrexate, a cancer drug used to treat childhood leukemia and osteosarcoma, are currently meeting all demand, and we do not expect any further supply issues. Also, to address the shortage of Doxil (liposomal doxorubicin), a drug used for ovarian cancer and other cancer regimens, FDA exercised enforcement discretion for the importation of Lipodox, another brand of liposomal doxorubicin, from India, meeting patient needs until Doxil is available again.
Leucovorin injection, a cancer drug that is used along with methotrexate for children with a serious form of leukemia, has been in short supply for some time. FDA is working with the manufacturer, Teva Pharmaceuticals, to produce additional shipments in the coming weeks to help improve supplies. Mustargen (Mechlorethamine HCl) – another cancer drug used in multiple cancer regimens — has also been in shortage. FDA has worked with the manufacturer to resume production of Mustargen, and the company is planning to have product available again by August.
Anesthesia drugs, such as benzodiazepines and fentanyl injections, have recently been in short supply as well. Here again, early notification is helping. One manufacturer, Hospira, notified FDA of anticipated delays in supply of the critical anesthesia drug propofol. This advanced notice allowed FDA to work with the other manufacturer of propofol who was able to increase supplies to keep the product available for patients undergoing surgery.
Consequently, Hamburg noted that FDA is working with Congress on addressing drug shortage issues in the upcoming User Fee Act negotiations.