I’ve posted about critical drug shortages before. This time though, the situation is different because the news appears positive. As a Drugs.com story earlier this week notes, the U.S. Food and Drug Administration (FDA) has announced that it is “cautiously optimistic” that a feared shortage of a life-saving drug used to treat a form of childhood leukemia will be averted.
The drug, methotrexate, is used in combination with other drugs to combat acute lymphoblastic leukemia (ALL), which typically strikes children ages 2 to 5, and is the most common type of cancer in children. In high doses, the generic drug has been successful in curing patients as well as preventing recurrence. According to the drugs.com story, oncologists say that without the drug, a patient’s chance for a cure is reduced while the risk of recurrence rises.
The problem, as USAtoday reports, is that until just a few days ago, cancer specialists had predicted they could run out of methotrexate by the end of next week, says pediatric oncologist Michael Link, president of the American Society of Clinical Oncology. The shortfall came about when one of the four U.S. makers of methotrexate, Ben Venue Laboratories, shut down production late last year because of “manufacturing and quality concerns,” FDA spokeswoman Shelly Burgess says.
In a statement, Ben Venue said it’s working closely with the FDA to bring methotrexate back to market as soon as possible, and that the company understands “the urgent need” for the medication.
Valerie Jensen, associate director of the FDA’s drug shortage program, says in the same story that the FDA sees the companies that make methotrexate responding to this shortage--and they are planning some very large releases. Consequently, the agency plans to have the situation resolved, she says. In fact, the agency expects some good releases at the end of this month and continuing into March and beyond, Jensen says.
While federal regulations bar the FDA from discussing plans of specific companies, as that’s considered proprietary information, The Washington Post reported earlier this week on those plans. Mylan, The Post reports, says it’s working on increasing manufacturing capacity, which includes getting approval for that from the FDA. The company has an emergency supply of small vials of methotrexate, and plans to ship larger vials at the end of the month.
Another company, Hospira, temporarily boosted production to address the shortage, but then ran out of the active ingredient. It’s still producing some of the drug, but is trying to get more of the active ingredient.
Finally, Sandoz aims to ship some of the drug in late February. The company did not provide any details, The Post notes.
Dr. Peter Adamson, chairman of the Children’s Oncology Group, a network of 200-plus North American hospitals treating children with cancer, said FDA officials have been reassuring in discussions that this is not going to be a prolonged shortage. Nevertheless, Dr. Adamson also says, until the drug is actually delivered, nobody can be sure.
The problem of short supplies of various drugs and price gouging is growing, however there have been recent in-roads. To address the escalating shortage of life-saving medicines, President Barack Obama signed an executive order last October that gives the FDA greater authority to manage shortages as well as counter price-gouging. Specifically, the order instructs the FDA to increase staff dedicated to addressing drug shortages, to press drug manufacturers to be more forthcoming about expected production delays that may lead to drug shortages, and to direct the agency to give the Department of Justice information so it can investigate claims of price gouging for short-supply drugs. Since then, the FDA has headed off 114 drug shortages, says FDA spokeswoman Burgess.
What do you think? What else can be done?