New GAO Report Blumenthal Requested Reveals Growing Number of Life Threatening Drug Shortages

(Washington, DC) —Today, Senators Tom Harkin (D-IA) and Richard Blumenthal (D-CT) released a new report from the Government Accountability Office (GAO) confirming that prescription drug shortages are on the rise, putting patients’ lives at risk. Blumenthal, along with Harkin, requested the hearing in May. At a HELP Committee hearing this morning, Marcia Crosse, Director of the GAO Health Care team, testified that drug shortages have increased since 2006, reaching a record number in 2010, and recommended that the Food and Drug Administration (FDA) be granted the authority to require drug manufacturers to report potential or current shortages.

Blumenthal said, “This report provides more proof that proactive steps are urgently needed to stem the severe public health crisis caused by a drug shortage epidemic that is escalating health care costs and preventing life-saving drugs from reaching patients. Aggressive measures are necessary to crack down on anti-consumer practices promoted by so-called "gray markets" that inflate prices, creating a public health menace. There should be zero tolerance for profiteering or price gouging in these essential drug markets.

“This report confirms that life-threatening drug shortages are becoming more prevalent, and are caused or exacerbated by disruptions in the drug supply chain, manufacturing problems, and communication breakdowns,” Harkin said. “These shortages often force Americans to go without treatment, or pay inflated prices for ‘gray-market’ drugs.  The good news is that the report also includes several constructive recommendations to address the underlying causes of this complex and growing problem.  I can assure you the bipartisan drug shortage working group that I convened in late May with Senator Enzi will evaluate this report closely in our continued effort to ensure that Americans are not forced to go without the life-saving medicines they need.”

The GAO report [LINK] reveals:

  • The number of drug shortages has increased substantially since 2006, from 64 drugs in 2006 to 196 in 2010
  • 65% of the shortages involved drugs that were scarce more than once
  • More than half of shortages defined as “critical” (lacking alternative drugs) from 2009-2011involved generic injectable drugs
  • FDA responds to shortages by providing assistance to resolve manufacturing or quality problems
  • FDA prevented 50 potential shortages in the first half of 2011 because they were alerted before the   shortages affected availability

In response to these findings, the report recommends that Congress establish a requirement for drug manufacturers to alert FDA to any changes that could affect drug supplies. Additionally, FDA should strengthen its ability to respond by developing an information system to manage data on drug shortages.