Casey Bill Would Give New Tools FDA to Prevent Shortages; Ensure Patient Access to Life-Saving Drugs
WASHINGTON, DC – U.S. Senator Bob Casey (D-PA) announced that a new report issued by the Government Accountability Office (GAO) supports his bill to confront the nation’s prescription drug crisis. At a hearing of the Health, Education, Labor, and Pensions Committee, Senator Casey applauded the report’s release and called for Congress to pass his bill to address drug shortages.
The report calls for Congress to pass a law that would require drug makers to alert the Food and Drug Administration (FDA) of potential or actual shortages and give the FDA the authority to seek civil monetary penalties for manufacturers who fail to report a drug shortage. Both of these steps are contained in Senator Casey’s bill, the Preserving Access to Life-Saving Medications Act.
“The shortage of life-saving drugs puts the care of seriously ill patients in jeopardy, and today’s GAO report is a clear call for action,” Senator Casey said. “I’ve introduced a bill that gets to the root of the drug shortage crisis by giving the FDA the tools it needs to identify a potential shortage before it becomes deadly and increase access to life-saving drugs to patients. Congress should pass the Preserving Access to Life-Saving Medications Act quickly.”
Senator Casey has been leading the way in confronting the nation’s drug shortage crisis. In February he was joined by Senator Amy Klobuchar (D-MN) in introducing The Preserving Access to Life-Saving Medications Act, and earlier this year he was joined by Senator Tom Harkin (D-IA) and Richard Blumenthal (D-CT) in urging the GAO to produce the study released today.
The GAO report 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.
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