The impact of drug shortages that have left doctors and patients scrambling for life-saving drugs became much more personal and real today at a U. S. Food and Drug Administration news conference.
Nebraska mother Sara Stuckey spoke at the event on behalf of her 6 -year-old son Nate, who needs a leukemia drug to survive. The Stuckeys are one of many families who have been directly affected by limited availability of these and other drugs. Michael Ball, CEO of Hospira (NYSE:HSP), one of the makers of generic methotrexate, said his company yesterday began shipping 31,000 vials of the injectable drug to address the shortage.
“Nate, we have you covered,” Ball said.
The FDA and industry representatives today announced combined steps to address growing drug shortages. But the immediate actions address just two cancer drugs — methotrexate and Doxil — and shortages affecting many other products remain an ongoing problem.
Methotrexate is used to treat children with acute lymphocytic leukemia as well as osteosarcoma, a malignant form of bone cancer. With supplies dwindling, the FDA gave priority review and approval for a preservative-free methotrexate generic made by APP Pharmaceuticals. APP production will begin in March and continue indefinitely. In the meantime, Hospira moved ahead in releasing additional supplies of its methotrexate. The 31,000 vials amount to a one-month supply — enough to bridge the gap until APP product hits the market.
For Doxil, the FDA is allowing temporary imports of a replacement drug called Lipodox as a treatment alternative. Doxil is used to treat ovarian cancer as well as in AIDS-related Kaposi’s sarcoma and multiple myeloma. The FDA said that temporary importation of unapproved foreign drugs is considered “in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs.”
The methotrexate shortage has been compounded by the plant shutdown of the drug’s largest manufacturer, Ben Venue Laboratories. The company last November voluntarily stopped making all products in order to address manufacturing problems. But before Ben Venue’s shutdown, the company had been working with the FDA on the release of already-manufactured, preservative-free methotrexate. That drug supply is currently available.
Manufacturing issues at the plants of several drugmakers have contributed to shortages of a growing list of drugs. Hospira, the industry’s largest maker of generic injectables, has been grappling with compliance issues at its Rocky Mount, North Carolina facility, the company’s largest site. That facility is operating at between 60 percent and 70 percent capacity as the company works to regain full FDA compliance. Hospira’s Ball today said that his company’s ability to manufacture methotrexate was not a capacity problem. Methotrexate is made at a Hospira facility in Australia and the challenge was in acquiring the active pharmaceutical ingredient needed to make the drug. Ball said Hospira worked with the FDA to identify alternative providers around the world for the active ingredient to make methotrexate. The company now aims to build up a “safety stock” to avoid future methotrexate drug shortages.
The FDA today issued draft guidance for companies that establish mandatory and voluntary notifications of issues that could spark future drug shortages. The guidance follows a presidential executive order last October that called on manufacturers to notify the FDA of the potential of a drug shortage as soon as the possibility arises.
[Photo courtesy of Hospira]