FDA Expands Efforts on Drug Shortages with Cancer Drug Supply Approval Actions and Event Reporting Guidance

FDA has announced additional steps to increase the supply of critically needed cancer drugs to help prevent current and future drug shortages, including approval of a foreign substitute product and accelerated approval of a new domestic supplier.  The agency has also released a guidance clarifying agency expectations for reporting events that could result in shortages of prescription products.

The approval actions specifically target shortages of the cancer drugs Doxil (doxorubicin hydrochloride liposome injection) distributed by J&J and the generic drug methotrexate.

“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 Hamburg in an agency 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.”

These new efforts come in the wake of an executive order and a follow-up agency letter to manufacturers issued at the end of October that resulted in a six-fold increase in notifications to the agency of product discontinuance or other problems that could cause a potential prescription drug supply disruption (IPQ “The News in Depth” February 12, 2012).

The follow-up letter sent by FDA to pharmaceutical manufacturers reminded them of their current legal obligations to report certain discontinuances to the agency and urged them to voluntarily notify it of all potential disruptions of the prescription drug supply to the US market, even where disclosure is not currently required by law.

The October letter has now been supplemented by a guidance document, in which the agency explains for both mandatory and voluntary notifications: ● why the notification is needed ● who should do the notifying ● what information should be reported ● when and how to perform the notification, and ● what FDA will do with reported information. The guidance also discusses certain advance planning strategies that manufacturers can consider to prevent or mitigate product shortages.

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