The Food and Drug Administration issued draft guidance detailing both mandatory and voluntary drugmaker notifications expected by the agency if the manufacturers foresee drug shortages or supply disruptions.
The guidance aims to implement President Barack Obama's Oct. 31, 2011 executive order aimed at spurring voluntary notifications by the pharmaceutical industry of potential shortages.
“The draft guidance clearly describes for industry how, what, when and why they should notify the FDA of an issue that could lead to a product shortage or a disruption in supply,” FDA Commissioner Dr. Margaret Hamburg, said in a Tuesday news conference.
Other early notifications to the FDA can have a “significant, positive impact” on addressing the incidence and duration of drug shortages, according to an administration statement, although additional manufacturing capacity is ultimately necessary to fully address the drug shortage problem. The agency has seen a sixfold increase in reporting since the voluntary reporting initiative was announced last year, Hamburg said.
The administration also is backing bipartisan legislation that would require drugmakers to report all prescription drug shortages to the FDA and give the agency new authority to enforce that requirement.
Beyond the notifications efforts, the administration announced two temporary initiatives to work around shortages of specific drugs. In one case, the administration will allow importations of an unapproved drug, Lipodox, to replace a pharmaceutical, Doxil, that has fallen into short supply. Such importations of drugs that have not cleared the FDA regulatory process are allowed under a newly established agency review of the quality and safety risks of the specific pharmaceutical.
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