FDA Grapples with Cancer Drug Shortages

Although the U.S. Food and Drug Administration (FDA) actively monitors and responds to the drug shortages that are common in oncology, these shortages continue to contribute to disease progression and other treatment-related complications—problems highlighted by a survey of 236 U.S. pharmacists.

Nearly all of the pharmacists reported shortages of at least one chemotherapy drug or other essential cancer treatment in 2011, leading to delays in drug administration or changes in treatment. The survey, which also showed that drug shortages affected the conduct of clinical trials at 44% of represented institutions, was done by St. Jude's Children's Research Hospital in Memphis, TN, and its results were published in the American Journal of Health-System Pharmacy.

Erin Fox, PharmD, director of the Drug Information Service (DIS) at the University of Utah Hospitals and Clinics in Salt Lake, points out that no new cancer drug shortages have been reported this year. The DIS is currently tracking 27 active shortages, she says, mainly of generic, injectable chemotherapies. “Most of these aren't critical shortages that could significantly impact care, but a few are,” she says. “Thiotepa, for instance, while available for import from Italy, is very difficult to obtain.”

Only a few companies make generic chemotherapies, so supplies can be easily disrupted by manufacturing problems, which occur with troubling frequency, Fox notes.

Christopher Kelly, a spokesperson for the FDA, says that the agency responds to these shortages in several ways. One is by speeding applications to boost drug and raw materials production at new plants, and another is by looking for alternate sources from foreign markets.

The FDA also intervenes in brand-name drug shortages. Earlier this year, the FDA sped approval of a generic version of Doxil (doxorubicin; Janssen), a treatment for ovarian cancer and multiple myeloma that was plagued by quality control problems at its manufacturing site in Bedford, OH. “The FDA uses every tool available under our current authority to address these shortages as quickly as possible,” Kelly says.

Fox agrees that the FDA's efforts are helping to prevent new shortages. Moreover, the Food and Drug Safety Innovation Act of 2012 directs manufacturers to alert regulators early on of potential disruptions in a drug's availability, buying time to find new sources, she says.

Still, Fox emphasizes that ongoing shortages are taking a long time to resolve, and for reasons largely beyond FDA control. “What really needs to happen is that manufacturing plants have to be updated and fixed,” Fox says. “But that's a business issue, and the FDA isn't in the business of fixing factories.”