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Drug importation authorized to ease shortages
The FDA announced that companies from Australia and India will be allowed to replenish the dwindling supply of methotrexate and doxorubicin.
Hospira announced it would import more than 62,000 vials of preservative-free methotrexate from Australia by early March — 2 months supply for the country — and another 55,000 vials by mid-month. The FDA also approved an application from APP Pharmaceuticals to manufacture methotrexate, which is crucial for the treatment of acute lymphoblastic lymphoma, bone cancers, brain tumors and lymphomas. Doxorubicin is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma.
FDA commissioner Margaret A. Hamburg, MD, said the agency was allowing “temporary overseas importation” of the doxorubicin (Doxil) substitute Lipodox from India by Sun Pharma Global. Importation is rare but sometimes necessary, she said.
“Lipodox remains unapproved by the FDA for the US market,” Hamburg said. “When a critical drug is unavailable and the substitute can produce a comparable outcome and has been evaluated by us for quality and safety, we use our enforcement discretion to allow for its temporary and limited use.”
Ben Venue Laboratories of Bedford, Ohio, one of four US manufacturers of methotrexate, voluntarily suspended operations in November after the FDA discovered “significant manufacturing and quality concerns.” The methotrexate supply steadily dwindled since then.
Max J. Coppes, MD, PhD, MBA, senior vice president of the Center for Cancer and Blood Disorders at Children’s National Medical Center in Washington, said the FDA should have looked outside the US sooner but still praised the agency for taking this step.
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“It’s a laudable decision based on the current shortages of drugs,” he said. “I would assume this is a one-time decision and I hope this will generate the discussion as to whether a process needs to exist that would allow importation to happen in other circumstances.”
Coppes, a HemOnc Today Editorial Board member, serves as an adviser to Health Canada, that country’s version of the FDA. Canada has an established plan to look internationally to address drug shortages, and Coppes said he would like to see the FDA establish a similar program.
“If drugs cannot be made in this country, patients should have access to life-saving drugs made elsewhere with the same standards we’re used to in the United States,” Coppes said.
Margaret R. O’Donnell, MD, associate clinical director of hematology and hematopoietic cell transplantation at City of Hope in Duarte, Calif., expressed doubts about these solutions in the long term.
“The US market is such a large market, I’m not sure foreign producers of these drugs can gear up to make five times what they usually make,” she said.
Ben Venue also manufactures the benzodiazepine midazolam (Versed), mitomycin (Mutamycin), metoclopramide (Reglan), prochlorperazine (Compazine), and bortezomib (Velcade) in partnership with Millennium Pharmaceuticals. Supplies of those drugs are running low as well.
City of Hope is out of metoclopramide and prochlorperazine, and a shortage of leucovorin prompted the hospital to switch to the more expensive L-leucovorin. The oncology community has been dealing with shortages of various drugs from a variety of manufacturers for the past 2 years, O’Donnell said.
“We are constantly trying to piece together drug supplies or alternative dosing schedules or alternative regimens to compensate for what’s not available,” she said. “Almost every week, there is a note from our pharmacist saying some drug is in short supply.” – by Jason Harris
Disclosure: Drs. Coppes, Hamburg and O’Donnell report no relevant financial disclosures.