President Barack Obama signed an
executive order that provides the Food and Drug Administration and the Justice Department with new resources and greater authority in dealing with the record number of drug shortages this year.
The executive order, which was announced today, requires the FDA to work with the Justice Department to investigate whether secondary drug distributors have illegally hoarded drugs in short supply or
engaged in price-gouging.
It also orders the FDA to add up to eight staffers to its drug shortages program and to expand expedited reviews of new manufacturing sites, drug suppliers and manufacturing changes that can mitigate the shortages.
In addition, the FDA is required to broaden the reporting of certain drugs—currently, a manufacturer is only legally required to notify the agency when production of a critical drug manufactured by one company is being discontinued.
The agency is also tasked with creating a voluntary notification process for manufacturers to disclose shortages.
“While additional manufacturing capacity is necessary to fully address the drug shortage problem, early disclosure can have a significant, positive impact on the incidence and duration of drug shortages,” according to a release announcing the executive order.
The executive order noted that voluntary early notification by manufacturers has prevented 99 drug shortages this year. The administration also
announced that it had sent letters to about 2,200 drug manufacturers encouraging them to voluntarily notify the FDA about potential shortages.
As of Oct. 31, there have been 232 reported drug shortages, compared to 178 for the full year of 2010, according to the University of Utah Drug Information Service. Almost half of the shortages, which include oncology drugs, antibiotics and electrolytes, have been attributed to manufacturing issues.
The
HHS assistant secretary for planning and evaluation and the
FDA both released reports about causes of the recent shortages.
