U.S. Senators Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) introduced legislation today that would provide the Food and Drug Administration with key tools to help address and prevent shortages of prescription drug medications, according to a news release from Sen. Klobuchar's office.
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.
The proposed bill 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.
A letter — jointly signed by the American Hospital Association, American Society for Anesthesiologists, American Society of Health-System Pharmacists, American Society of Clinical Oncology and the Institute for Safe Medication Practices — expresses support of Sens. Klobuchar and Casey's proposed legislation.
Read the news release about the Preserving Access to Life-Saving Medications Act.
Read other coverage about drug shortages:
- Drug Shortages Could Force Physicians to Choose Risky Alternatives
- How to Temporarily Overcome Drug Shortage: Q&A With Sheldon Sones of Sheldon S. Sones and Associates
- Drug Shortages the Focus of Special Meeting
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.
The proposed bill 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.
A letter — jointly signed by the American Hospital Association, American Society for Anesthesiologists, American Society of Health-System Pharmacists, American Society of Clinical Oncology and the Institute for Safe Medication Practices — expresses support of Sens. Klobuchar and Casey's proposed legislation.
Read the news release about the Preserving Access to Life-Saving Medications Act.
Read other coverage about drug shortages:
- Drug Shortages Could Force Physicians to Choose Risky Alternatives
- How to Temporarily Overcome Drug Shortage: Q&A With Sheldon Sones of Sheldon S. Sones and Associates
- Drug Shortages the Focus of Special Meeting