Administration takes action on Klobuchar-Casey early warning system
WASHINGTON, DC – U.S. Senator Bob Casey (D-PA) is pleased that elements of his bipartisan proposal to address critical drug shortages through early warning notifications will be advanced as part of an Executive Order issued by President Obama. As the President announced the administrative action he gave full support to the Preserving Access to Life-Saving Medications Act, legislation Senator Casey introduced with Senator Amy Klobuchar (D-MN) that would require pharmaceutical companies to notify the Food and Drug Administration (FDA) of impending prescription drug shortages so appropriate actions can be taken to mitigate such shortages.
“This action will help ensure that patient care is not jeopardized by a lack of life-saving medication,” said Senator Casey. “Patients and hospitals in Pennsylvania and around the country have experienced an inexcusable shortage of life saving drugs, and I am pleased that the legislation I have been pushing is part of the strategy announced today.”
The Preserving Access to Life-Saving Medications Act would give the FDA the ability to require early notification from pharmaceutical companies when a factor arises that may result in a shortage. These factors may include changes made to raw material supplies, adjustments to manufacturer production capabilities, and certain business decisions such as mergers, withdrawals, or changes in output. The bill would also direct the FDA to provide up-to-date public notification of any actual shortage situation and the actions the agency would take to address them. The FDA has prevented 99 drug shortages so far this year due to voluntary early notifications from companies, up from 38 in 2010. FDA officials have said that the rise in preventions is due to increased pressure from the senators and other members of Congress.
President Obama today signed an Executive Order implementing the key provision in the bill, including requiring pharmaceutical companies to notify the FDA of impending prescription drug shortages. The Executive Order directs the Food and Drug Administration to (1) require drug companies to notify the FDA of any impending shortage of certain prescription drugs, (2) speed reviews of applications to begin or alter production of these drugs, and (3) work with the Department of Justice to examine whether drug companies have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers.
In addition to the legislation, Casey and Klobuchar are also members of a bipartisan drug shortages working group, which includes Senators Richard Blumenthal (D-CT), Richard Burr (R-NC), John McCain (R-AZ), and Bob Corker (R-TN). The working group is aimed at bringing together patients, doctors, pharmacists, manufacturers, and the FDA to focus on long-term solutions to stop drug shortages. Last month, the FDA convened a public workshop at the request of the working group which brought together patient advocates, industry, consumer groups, health care professionals, and researchers to discuss the causes and impact of drug shortages and possible strategies for preventing or mitigating future shortages.
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