FDA Addressing Critical Cancer Drug Shortage

Doxil and methotrexate supplies to be bolstered immediately

(RxWiki News) The drug shortage that began in 2011 has had a tremendous impact on cancer drugs, leaving some lifesaving medications in dangerously short supply. The U.S. Food and Drug Administration (FDA) has announced a series of steps to deal with this crisis.

This new initiative complies with an Executive Order President Obama signed in October, 2011 to bolster current supplies and help prevent future shortages.

"Ask your pharmacist about supplies of your medications."

The FDA has taken action to address the severe shortage of the chemotherapy drug Doxil (doxorubicin hydrochloride liposome injection) and the dwindling supplies of methotrexate, which is used to treat childhood leukemia and other cancers. 

For Doxil, the replacement drug Lipodox (doxorubicin hydrochloride liposome injection) will be temporary imported. This is expected to end the shortage and fully meet patient needs in the coming weeks.

Doxil is used in a variety of treatments, including treatment of ovarian cancer after failure of platinum-based chemotherapy, AIDS-related Kaposi’s sarcoma and multiple myeloma.

FDA’s exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. Such arrangements are rare.

For methotrexate, in addition to already announced actions to have existing manufacturers ramp up production, the FDA has approved a new manufacturer that is expected to further bolster supply and help prevent a shortage.

Methotrexate, is needed for the treatment of many forms of cancer and other serious diseases. The FDA recently engaged many firms to assist in maintaining supplies to meet all patient needs, including children with acute lymphocytic leukemia (ALL).

“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. “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.”

For other prescription drug shortages, the FDA issued draft guidance regarding both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption.

In addressing the growing drug shortages, the Administration also announced in its Executive Order  its support for bipartisan legislation that would require all prescription drug shortages to be reported to FDA and would give FDA new authority to enforce these requirements.

While additional manufacturing capacity is necessary to fully address the drug shortage problem, additional early notification to FDA can have a significant, positive impact on addressing the incidence and duration of drug shortages.