Drug shortage crisis averted, for now

Some 31,000 units of preservative-free methotrexate, equivalent to a month's supply of the drug for the entire nation, are currently on their way to hospitals around the country, said Michael Ball, CEO of the drug manufacturer Hospira, in a Food and Drug Administration (FDA) press conference on Tuesday. "Next week," said Ball, "we'll release 34,000 vials, another month's worth. By mid-March, we'll release another 55,000 vials." Hospira is one among a handful of drug manufacturers picking up the slack for the nation-wide shortage of this life-preserving drug used for the treatment of acute lymphoblastic leukemia (ALL), the most common type of childhood cancer that is 90 percent curable with regular injections of methotrexate.Last Friday, APP, another drug manufacturer, received FDA approval to produce preservative-free methotrexate and will begin supplying clinicians in the next four to six weeks. Two other manufacturers, Mylan Pharmaceuticals and Sandoz, have also agreed to ramp up production.The FDA also announced in yesterday's briefing that they have found a substitute for Doxil (doxorubicin) a drug used to treat various forms of ovarian and lung cancers. Lipodux, produced by manufacturer Sun Pharma Global FZE, will temporarily replace Doxil, which has been in short supply since July.While this news certainly comes as a relief to parents, healthcare providers, and of course, the patients whose very survival depends on methotrexate or Doxil, many say this situation is sure to happen again. "The system is fragile," said Peter C. Adamson, MD, the current chair of the Children's Oncology Group, who sat on the panel at yesterday's briefing. "For many of these drugs, there may be a sole provider. There are potential future crises that are waiting to happen."In October, President Obama issued an executive order instructing drug manufacturers to report potential shortages to the FDA in a timely fashion so the agency has time to find other drug alternatives. In addition, the FDA said it was working on developing even tougher legislation that would create permanent solutions for these recurring drug shortages, although the agency admits these shortages stem from complex issues that include the problem of demand outpacing supply, particularly when it comes to generic drugs that have lower profit margins than brand name drugs, as well as other economic and legal issues.Adamson concluded the nearly hour-long briefing with a comment that perhaps resonates most with the general public. "I understand that passing legislation is a complex and difficult process, but no more difficult than curing a child with cancer."