Bill would create early warning system to guard against prescription drug shortages
WASHINGTON, DC— U.S. Senators Bob Casey (D-PA) and Amy Klobuchar (D-MN) introduced legislation today that would provide the Food and Drug Administration (FDA) with key tools to help address and prevent shortages of prescription drug medications. The Preserving Access to Life-Saving Medications Act will require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage. The American Society of Health-System Pharmacists currently lists 150 “medically necessary” drugs that are in short supply, which is double the number from five years ago.
“Knowledge is one of the most important tools for combating problems associated with drug shortages, which are a growing threat to public health in Pennsylvania and across the U.S.,” said Senator Casey. “Several major hospitals in our state have experienced shortages that are jeopardizing patient care and this bill will provide the knowledge required to help address and prevent future shortages.”
“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available – that’s not right,” said Senator Klobuchar. “This common-sense solution will help set up an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible. As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA and health care providers so patients don’t lose access to the medications they depend on.”
Pharmacists and health care providers have been reporting unprecedented shortages of prescription drugs, especially for chemotherapy. Experts cite a number of factors behind the shortages, including scarcity of some raw materials, manufacturing problems and unexpected demand. Business decisions within the pharmaceutical industry are also a factor, such as cutting back on the production of low-cost generic drugs in favor of more profitable brand-name drugs.
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 shortage situation and the actions the agency would take to address them.
The legislation is supported by the American Hospital Association, the American Society of Clinical Oncologists and the Institute for Safe Medication Practices.
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