FDA Expects Drug Manufacturers to Intimate 6 Months in Advance of an Upcoming Drug Shortage
Posted on: Thursday, July 9, 2015

Starting 1st of September this year (2015), FDA will require all manufacturers of drugs or biological products including manufacturers of blood or blood components for transfusion to notify FDA electronically of a permanent or temporary discontinuation in the manufacturing of their product that is likely to lead to a significant disruption in supply of that product in the US. In the recent past, several long- or even short-term disruption in drug supplies lead to huge public outcry. In some cases, treatments for life-threatening diseases were not available such as the case of cancer drug Doxil, leading to many patients either scrambling to find alternate therapies that were not as effective or forgo treatment altogether leading to worsening of the disease. The most common cases of disruption in supply are changes in business priorities, changes in manufacturing practices, sale or transfer of ownership, or other business, financial or logistical reasons. In most of those cases, it is not hard for the manufacturer to anticipate production interruption well in advance, so the 6 month notice is not unreasonable as it gives FDA enough notice to inform the patients and try to find alternate solutions for patients. The rules does allow exception in cases where a 6 month notice cannot be reasonably predicted such as contamination in manufacturing suites, unplanned manufacturing shutdowns, the manufacturer must inform FDA as soon as possible  but no later than 5 business days after the disruption has occurred. In the rule, FDA did not include any punitive elements for non-compliant companies which seems strange but that may be coming in the Guidance document to further clarify the rule.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research