US President Barack Obama today issued an executive order aimed at battling shortages of important and sometimes crucial prescription drugs that are impacting patient care and clinical trials of new medications.
“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,” the president said. “This is a problem we can’t wait to fix”.
In this press release, the White House noted that reported shortages of prescription medicines nearly tripled between 2005 and 2010.
And according to this Congressional testimony by Charles Penley of the American Society of Clinical Oncology before the House Energy and Commerce Committee’s health subcommittee in September, over 150 clinical trials sponsored by the National Cancer Institute involve drugs that are in short supply. (Last month, Nature wrote about the problem’s impact on cancer clinical trials here.)
Using the limited, but still considerable, power of an executive order to attack the problem, Obama directed the Food and Drug Administration (FDA) to broaden required reporting by manufacturers when shortages or discontinuations of certain drugs loom, and to speed up agency reviews that can help prevent shortages, or respond to them. (The reviews include examinations of new manufacturing sites, drug suppliers, and manufacturing changes.) To underpin the effort, Obama directed more money towards staffing the FDA’s Drug Shortages Program office.
Obama also announced his support for bipartisan legislation that has been languishing in both houses of Congress. (The House bill is here; its Senate counterpart can be seen here.) It would require drugmakers to disclose all prescription drug shortages to the FDA in advance and give the FDA new muscle to enforce these requirements. (Currently, the agency can only require require a drug manufacturer to disclose the discontinuation of a critical drug when that company is the only one that makes the drug.)
The FDA itself reinforced the message, sending this letter to drugmakers. “We remind you of your obligation to report such discontinuances,” it notes, promising further, written guidance that specifically identifies the information the FDA wants from the companies.
At the same time, the drug oversight agency released this report, outlining its approach to, and role in, responding to drug shortages.
The Department of Health and Human Services today put out a separate report examining the economic roots of the current shortages, which do not affect the majority of drugs. Where problems arise, the report finds, the causes include growing demand, manufacturing problems, a consolidation of manufacturers and, in some cases, price gouging by wholesalers during shortages.
For instance, the White House press release noted that in recent testimony to Congress, it was reported that “a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial – 80 times higher.”
It remains to be seen whether the executive order will remedy the growing problem in the absence of action from Congress. The number of shortages this year has already surpassed the number for the whole of 2010 says Erin Fox, the manager of the Drug Information Service at the University of Utah Hospitals and Clinics in Salt Lake City. Fox presented a decade’s worth of shortage numbers in this slide show at a September 26 public workshop on the shortage problem convened by FDA (see graph).
The Drug Information Service in Utah has been collecting and providing shortage data to the American Society of Health-System Pharmacists since 2001. You can read up-to-the-minute information about specific shortages, medicine-by-medicine, at the Society’s website, here.