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Drug Shortage Crisis Averted, for Now

The FDA has a plan to quell recent cancer drug shortages.

PUBLISHED March 14, 2012

In February, the Food and Drug Administration (FDA) helped quell a potentially dangerous situation by quickly approving a new supplier to produce preservative-free methotrexate.

Methotrexate is used to treat acute lymphoblastic leukemia (ALL), the most common type of childhood cancer. ALL is 90 percent curable with regular injections of methotrexate. Several other drug manufacturers were also recruited to ramp up production of the drug.

The FDA was also able to locate a substitute for Doxil (doxorubicin), a drug used to treat ovarian cancer, as well as other types of cancer. Lipodux, produced in India by Sun Pharma Global FZE, will temporarily replace Doxil, which has been in short supply since July.

The current methotrexate crisis began in October when Ben Venue Laboratories, the primary maker of the generic drug, voluntarily shut down its Ohio-based plant to address quality issues. While methotrexate has been in and out of short supply since 2008, the plant’s closing left hospitals scrambling to find more of the drug. By winter, many healthcare providers across the U.S. had reported that they had only a few weeks’ supply of methotrexate remaining.

In response to the shortage, the FDA fast-tracked approval for drug manufacturer APP Pharmaceuticals to produce methotrexate. Other manufacturers—Hospira, Sandoz and Mylan—have also increased production.

“We believe that they will be able to meet the needs of patients on a continuing basis,” said FDA commissioner Margaret A. Hamburg, MD, at a February press conference. “This should resolve the shortage.”

Still, many say this situation is sure to arise again.

“For many of these drugs, there may be a sole source provider,” said Peter C. Adamson, MD, the current chair of the Children’s Oncology Group, who sat on the panel at the February briefing. “There are potential future crises waiting to happen.”

In November, President Obama initiated an executive order to tackle the growing shortages of medicines used to treat some forms of cancer and other diseases. The order instructs the Food and Drug Administration to hasten applications for companies to produce these drugs, to report on potential shortages of other drugs and to supply the Justice Department with evidence of companies that price gouge.

The order came after months of disagreements in Congress on how to settle this issue. About 35 to 40 percent of the total cancer drugs have been in short supply recently.

We believe that they will be able to meet the needs of patients on a continuing basis. This should resolve the shortage.

While there are many reasons for these shortages, a major factor includes regulatory and manufacturing issues. When one or more plants shut down, other manufacturers cannot pick up the slack because of their own production demands. In some cases, one or two companies may be the only producers of a drug—a system Adamson calls “fragile.”

Monetary factors also contribute to the shortage. The federal Medicare Prescription Drug, Improvement, and Modernization Act, enacted in 2003, keeps the price of drugs low by limiting the price increase to 6 percent every six months. If the price of generics erodes, some companies may choose to cease production of the less profitable drug in favor or manufacturing one that is more profitable.

Shortages of oncology drugs bring serious ramifications. When first-line medications are unavailable, physicians may need to delay treatment or opt for alternative treatments. The shortage is even affecting clinical trials of new drugs. These generics are often the backbone of standard treatment regimens, so it’s difficult to combine and compare new regimens if the older ones are hard to come by.

At its February press conference, the FDA said the agency was working on developing even tougher legislation that would create permanent solutions for these recurring drug shortages, although they admitted resolving them would be difficult.

Near the end of the briefing, Adamson made a statement that might resonate most with the general public.

“I certainly understand that passing legislation is complex and difficult,” Adamson said, “but no more difficult than curing a child with cancer.”

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