FDA announced a series of steps to increase the supply of critically needed cancer drugs, including temporarily importing an unapproved drug from India. The moves are building on President Barack Obama's executive order to help prevent future drug shortages, FDA said
FDA announced a series of steps to increase the supply of critically needed cancer drugs, including temporarily allowing 2 drugs to be imported. The moves are building on President Barack Obama’s executive order to help prevent future drug shortages, FDA said.
The actions were taken specifically to deal with the critical shortage of the cancer drug doxorubicin (Doxil) and rapidly declining supplies of methotrexate for patients in the United States.
The short supplies of both drugs occurred after Ben Venue Laboratories closed its plant in Beford, Ohio, because it could not guarantee the safety of the products.
For Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks, FDA said.
In addition to already announced actions, FDA has approved a new manufacturer of preservative-free formulation of methotrexate, which is expected to further bolster supply and help avert a shortage of this lifesaving medication used to treat childhood leukemia. FDA expedited review of the application to help address this potential shortage.
“From the perspective of the clinician, this action should counteract potential treatment delays and preserve more beneficial patient outcomes,” Steven J. Crosby, MA, BSP, assistant professor of pharmacy, Practice School of Pharmacy-Boston, College of Pharmacy and Health Sciences, Boston, told Formulary. “Further, the increase in voluntary notifications can allow practitioners to be more proactive in the selection of acceptable therapeutic alternatives for proposed shortages. It is an opportunity for clinicians to utilize their comparative drug evaluation skills.”
FDA also issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption.
Under FDA’s exercise of enforcement discretion, the chemotherapeutic drug Lipodox will be imported from India as an alternative to Doxil. Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi’s sarcoma and multiple myeloma.
Temporary importation of unapproved foreign drugs is rare. When a company is identified as willing and able to import the needed drug product, FDA evaluates the foreign-approved drug to ensure that it is of adequate quality and that the drug does not pose significant risks for US patients.
With regard to methotrexate, a drug that is needed for the treatment of many forms of cancer and other serious diseases, FDA has prioritized review of and approved a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals, and expects that the product will become available in March and continue indefinitely.
Also, Hospira expedited release of additional supplies from its plant in Australia, resulting in 31,000 vials of new product-enough for more than 1 month’s worth of demand-being shipped to hundreds of US hospitals and treatment centers. FDA said it is actively working with other manufacturers of methotrexate that have also stepped up to increase production in order to meet patient needs, including Mylan and Sandoz Pharmaceuticals.