FDA Takes Aggressive Steps to Reduce Drug Shortages

The FDA announced plans to strengthen the supply of 2 scarce cancer drugs: methotrexate and Doxil (doxorubicin hydrochloride liposome injection).

In November 2011, Ben Venue Laboratories, the third party manufacturer of the drugs methotrexate and Doxil, reported it would indefinitely extend a voluntary suspension of production at its Bedford, Ohio, facility. As a result of the closure Doxil will be inaccessible until late 2012 and the supply of methotrexate began declining late last year.

To supplement the Doxil inventory the FDA temporarily endorsed the importation of a replacement drug, LipoDox (doxorubicin hydrochloride liposome injection), which contains the same active ingredients as Doxil. The replacement agent is manufactured in India by Sun Pharma Global FZE and is distributed by Caraco Pharmaceutical Laboratories Ltd.

“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," said FDA commissioner Margaret A. Hamburg, MD, in a press release.

Focus has only recently been placed on the supply of the drug methotrexate. A preservative-free version of this drug is used to treat children with acute lymphoblastic leukemia; a condition that is most common in children aged 2—5.

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Several firms have worked to ramp up production of methotrexate. Hospira, a expedited the delivery of 31000 vials of the drug from Australia, which will last approximately 1 month. In a further effort to reduce the shortage the FDA quickly reviewed and approved a preservative-free methotrexate generic for the company APP Pharmaceuticals that should become available in March.

As part of the foreign review process the FDA deemed that the agents produced at the foreign manufacturing plants were of adequate quality and did not present significant health risks to patients in the US.

The efforts to alleviate the drug shortages came about as part of an Executive Order issued by President Obama. As a result of the order, voluntary reports of potential shortages have increased 6-fold, according to an FDA press release.

“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,” Hamburg stated.

In 2011, 195 drug shortages were prevented with more than 100 being avoided since the Executive Order in October 2011.