With the US Congress largely in a state of ineffectual paralysis, President Barack Obama has turned to his executive authority to get things done. Last week, he signed an executive order that will shorten the time it takes to turn federally-funded research into commercial products. And this afternoon, he pushed through an executive action aimed at tackling the current drug shortages affecting patients, doctors, clinical trials and biomedical researchers nationwide.
There are currently more than 200 drugs and biologics in short supply — a record high up from just 56 five years ago. To bring that number down, Obama’s order directs the US Food and Drug Administration (FDA) to demand better shortage reporting from drug manufacturers, to expedite any applications that could bring drug production back on track and to communicate any reports of price gouging on the drugs out there to the Justice Department.
“It’s encouraging to see this level of engagement,” says Kasey Thompson, the vice president of policy at the American Society of Health-System Pharmacists in Bethesda, Maryland. “Is it going to solve drug shortages tomorrow? Probably not. But directing the FDA and the Department of Justice in particular to describe the grey market more thoroughly is important.”
Before Obama’s pen even graced the paper, however, the FDA was already beginning to lay the blame elsewhere. This morning, agency commissioner Margaret Hamburg published an open letter addressed to drug manufacturers, noting that more than half of all drug shortages last year were caused by problems at the manufacturing plants themselves. Thus, she argued, industry needs to uphold quality standards rather than expect the FDA to pick up the production pieces. “The American public counts on companies like yours to ensure drug quality and safety, so that patient care is not compromised,” Hamburg wrote.
Erin Fox, manager of the University of Utah’s Drug Information Service in Salt Lake City, agrees that industry needs to speak up to recover from the drug shortages. “We don’t know why companies are having manufacturing problems in the first place,” she says. “The chief difficulty in trying to solve this crisis is that we don’t have a full understanding of the problems at hand.”