FDA Issues Draft Industry Guidance to Ameliorate Critical Drug Shortages
(ChemotherapyAdvisor) – Building on President Obama's Executive Order to prevent future drug shortages or supply disruption, the U.S. Food and Drug Administration (FDA) issued draft guidance to industry on February 21 that details “requirements for both mandatory and voluntary notifications to the agency of issues that could result” in such shortages.
“FDA is concerned about the rising incidence of drug shortages in the United States, particularly those involving drugs that are manufactured by a small number of firms and for which there are no good therapeutic substitutes available,” the draft guidance states.
The agency also recently moved to allow temporary importation of Lipodox, a replacement drug for Doxil, and approved a new manufacturer of a preservative-free formulation of methotrexate in addition to working with other manufacturers to increase production and expedite release of supplies.
In 2011, the FDA tracked more than 250 drug shortages, which have been increasing steadily over the past five years, tripling from 61 in 2005 to 178 in 2010. Drug shortages may result in “use of less desirable, often more expensive alternatives and the potential for medication errors and poor patient outcomes,” according to a survey by the Institute for Safe Medication Practices.
The October 31, 2011 Executive Order and FDA letter to manufacturers resulted in a sixfold increase in voluntary notifications by industry of potential shortages, the FDA noted. In 2011, 195 drug shortages were prevented and, since the Executive Order, 114 drug shortages prevented.
Doxil (doxorubicin hydrochloride liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy; treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy; and treatment of multiple myeloma in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy. Preservative-free methotrexate is used for intrathecal treatment of children with acute lymphocytic leukemia and for high-dose treatment of osteosarcoma.
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