The US Food and Drug Administration has launched a two-pronged plan designed to combat the problem of medicine shortages.
The first scheme will see the agency look to improve its own response to “imminent or existing shortages, and for longer-term approaches for addressing the underlying causes of drug shortages”. The plan also highlights opportunities for drug manufacturers and others to prevent shortages “by promoting and sustaining quality manufacturing”.
Secondly, the FDA has issued a proposed rule requiring all manufacturers of “certain medically important prescription drugs” to notify the agency of a “permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply”. The rule also extends this requirement to makers of biologics.
The plan was made in response to an order from the Obama administration two years ago to resolve the shortage problem. Between 2005 and 2011, the number of new shortages quadrupled to 251. Although the figure fell to 117 last year, more than 300 ongoing shortages existed as 2013 got under way. The FDA Safety and Innovation Act also requires the agency to improve its response.
The agency notes that progress has already been made following President Obama’s 2011 executive order on reducing drug shortages. The number of new shortages in 2012 was 117, down from 251 in 2011, and since the Order, there has been a six-fold increase in notifications to the FDA.
The agency claims that it helped prevent 195 drug shortages in 2011 and 282 last year. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said “the complex issue of drug shortages continues to be a high priority [and] early notification is a critical tool that helps mitigate or prevent looming shortages”.
She added that the agency “continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders”.
The agency’s move has gone down well and the American Society of Hematology president Janis Abkowitz said it is particularly pleased that it includes biologics. The latter, “which range from chemotherapeutic agents used to treat patients with blood cancers to plasma protein therapy products and their recombinant analogues used for the treatment of haemophilia and other bleeding disorders, are critical to the delivery of care,” she said.
