Why a White House order on drug shortages matters

at 02:44 PM ET, 10/31/2011

This morning President Obama signed an executive order
(IStockphoto)
intended to combat a wave of prescription-drug shortages in the United States. Unlike some other parts of the White House’s “We Can’t Wait” agenda, which may not produce sweeping changes without congressional cooperation, advocates say, this new order could make a difference.

Drug shortages have tripled since 2006. As my colleague Rob Stein has reported, the shortages can lead to patients’ prescriptions running out mid-treatment, as well as price gouging by drug companies.

Last month, a diverse coalition of health-care industries issued five recommendations on how to address drug shortages, and the executive order today contains a lot of overlap with those. Both call for increased staffing at the Food and Drug Administration to monitor drug shortages as well as for more pressure on drug companies to report looming shortages earlier on. Increased monitoring of price gouging for scarce drugs and more aggressive reporting requirements also factor into both plans.

To be sure, there are some things this executive order can’t do. Right now, federal law requires reports only from “single source” drug manufacturers, those that are the sole producers of a given medication. Pending legislation in the House and Senate would require all drug manufacturers to report looming shortages.

“I’ve been tracking these issues for a decade now, so to see the president bring it up is important to us,” says Kasey Thompson, vice president for policy at the American Society of Health-System Pharmacists. “The fact that multiple agencies are on task and working on this is very encouraging to me.”

An even bigger challenge is figuring out why, exactly, drug shortages are happening. The number of shortages has surged in recent years, and although a number of possible explanations have been floated, there’s little consensus on why. “It’s one of those situations where there seem to be a variety of factors [and it’s] difficult to pinpoint what has caused drug shortages,” Rep. Diana DeGette (D-Colo.), a sponsor of drug shortage legislation, told me in a recent interview. Without clear causes, its difficult to gauge which policy interventions would be most successful.

One other notable element of the executive order: It does not call for a national stockpile of rare drugs. The Obama administration reportedly discussed the approach, but many questioned its practicality. “The problem with doing a national stockpile is there are so many types of drugs and they’re changing all the time,” says DeGette. Instead, the executive order signed today hews relatively closely to what advocates and legislators have pushed for months now.

 
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