FDA Takes Proactive Steps to Prevent Cancer Drug Shortages - - BioPharm International

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FDA Takes Proactive Steps to Prevent Cancer Drug Shortages


BioPharm Bulletin

On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama’s Oct. 31, 2011 Executive Order.

FDA announced a temporary importation of the chemotherapeutic drug Lipodox (doxorubicin hydrochloride liposome injection) in response to the shortage of Doxil (doxorubicin hydrochloride), used in the treatment of ovarian cancer and AIDS-related Kaposi’s sarcoma and multiple myeloma. FDA expects the importation of this replacement drug to end the shortage and meet patient need within weeks.

Supply of methotrexate is also in decline. FDA, seeking to increase supply, approved a preservative-free formulation of methotrexate manufactured by APP Pharmaceuticals, a subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. FDA expedited the review of the drug maker’s application to ensure the supply of the cancer drug. The drug is expected to become available in March. The agency has also engaged many firms to assist in maintaining supply. Hospira expedited the release of additional supplies, resulting in 31,000 vials of new product, and Mylan and Sandoz Pharmaceuticals have increased production. Methotrexate is used to treat a variety of cancers as well as other diseases.

FDA also issued a draft guidance detailing requirements for mandatory and voluntary notifications to the agency of potential problems that could disrupt the drug supply.

FDA stated, in a press release, that the President’s Executive Order and FDA’s letter to manufacturers have increased awareness of the importance of early notification and that awareness has “resulted in a sixfold increase in voluntary notifications by industry of potential shortages. In 2011, there were a total of 195 drug shortages prevented. Since the Executive Order, FDA has prevented 114 drug shortages.”

“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Margaret A. Hamburg, M.D., in the press release. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

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