FDA Steps In To Ease Cancer Drug Shortages

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FDA Steps In To Ease Cancer Drug Shortages

by Colleen Shaddox | Feb 21, 2012 4:15 pm

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Dr. Jeffrey Gordon wants to treat a new patient with ovarian cancer with Doxil, a chemotherapy drug that’s proven highly effective against the disease. But he is unable to obtain Doxil because, like many other potentially lifesaving drugs, it is in short supply.

“It’s really become a crisis,” said Gordon, an oncologist with New London Cancer Center.

The Food & Drug Administration announced Tuesday that it would approve importation of a replacement drug for Doxil, called Lipodox. Supplies of Lipodox will end the Doxil shortage within weeks, according to the FDA.

The FDA also announced that it has asked other drug companies to begin producing or increase production of Methotrexate, a cancer drug used to treat children with leukemia. The drug is mainly manufactured by Ben Venue Laboratories.

Drug availability continues to concern doctors and patients. The FDA currently lists 115 drugs as being in shortage. The list is largely populated by generic injectable drugs, many used in chemotherapy.

Resellers profit from these shortages by stockpiling drugs, then selling them off when a shortage hits. “Hospitals get bombarded with various third-party vendors,” said Gordon. “The price is astronomical.”

The practice is currently legal, though under investigation by the U.S. House Oversight Committee.

U. S. Sen. Richard Blumenthal’s office recently surveyed five Connecticut hospitals and found that drug shortages were sharply on the rise. Blumenthal reported that the survey showed drug shortages increased 49.6 percent on average from 2008-09. From 2009-10, the average increased by 76.1 percent.

Health care experts say the shortages are driven by a complex web of manufacturing and regulatory practices and will not be abated easily.

Often the production of injectable drugs is shut down by authorities or voluntarily suspended by the company because of quality issues, as was the case with Methotrexate, explained C. Michael White, head of the Department of Pharmacy Practice at the University of Connecticut School of Pharmacy.

A particle of just .05 micrometers can ruin a sterile injectable drug, he added. Thus the manufacture of these medicines is complex and expensive. Yet to achieve good sales, generics must keep down their prices. “There’s no financial incentive to build a new plant,” said White.

A “lack of transparency” exacerbates the problem, as manufacturers are not required to report to the FDA on anticipated shortages, or even plans to suspend production of a drug altogether, said White. A shutdown can lead to crisis when a drug is only manufactured by a single company, as is often the case.

Blumenthal is sponsoring legislation that would require more disclosure from manufacturers. He also joined a group of senators who’ve asked Ben Venue for more information about the Methotrexate shortage, including data on the drug’s profitability. Ben Venue did not respond to a request for comment.

The Generic Pharmaceutical Association, an industry trade group, is proposing that a third party monitor supplies of sterile injectables and share information with manufacturers and the FDA.

In an information vacuum, hospital pharmacies sometimes stockpile drugs that could go into shortage, increasing costs, said White.

Meanwhile, doctors work to find viable alternatives for their patients. Sometimes – but not always—there are choices that offer similar benefits to drugs in shortage, Gordon said. “There are some drugs that there are no substitutes for,” he said.

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