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.