Drug Shortage Crisis Could Kill Children

The drug shortage in the United States has reached a tipping point. We are now in a crisis of epic proportions and no one seems to know what to do about it.
The Food and Drug Administration just announced that supplies of the critical medicine methotrexate, used to treat leukemia in children, are dangerously low. We could run out of this essential drug within days. Children who could otherwise be cured may die for the lack of this medication.
Over the last several years drug shortages have become commonplace. They have affected drugs required for anesthesia, pain control, heart procedures, treating infections and reversing life-threating anaphylactic reactions. There have also been other shortages of anticancer drugs, but this is the first time that children’s lives hang in the balance.
For decades, pediatric oncologists have been saving the lives of children diagnosed with Acute lymphoblastic leukemia (ALL). Methotrexate (without preservatives) has been a staple of the protocol. Now, without adequate supplies of preservative-free methotrexate, many kids with cancer are in grave danger.
How did we end up in such dire straits? Manufacturing problems have become commonplace. In this particular case, the company that makes most of the injectable preservative-free methotrexate used in this country shut down their plant in Ohio to correct “significant manufacturing and quality concerns.” The problems at that plant had led Canadian health authorities to ban 17 drugs manufactured there. Officials estimate that it may take 9 months before this manufacturing process is back to full production.
In the meantime, other companies are scrambling to improve output, but it is not clear how long it will take to replenish the supply pipeline. FDA is so desperate that it is looking to foreign suppliers to provide enough methotrexate to fill the void. That too could take time.
The FDA has no power to make drug companies manufacture medicine. In fact, there is no governmental authority that can do so. At last count, 180 important medicines are in short supply. That is a dramatic increase over the last several years.
No one seems to be able to explain why generic drug companies are no longer making adequate amounts of medicine to meet the needs of the nation. Some have blamed companies for putting profits ahead of patients’ lives. If the generic drug manufacturers of America want to retain the respect and good will of the public, they will have to come up with a workable solution to prevent the kind of drug shortages that put innocent children’s lives at stake. If they won’t immediately take action, then Congress may be forced to do so.
If you would like to let the Generic Pharmaceutical Association know what you think about the current drug shortage situation, you can call: 202-249-7100, write: 777 Sixth St., NW, Suite 510; Washington, DC 20001; or go to the website and email: http://www.gphaonline.org/about/contact
You may also want to contact your Senator and Representative and demand that they take action!