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
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
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.