The statement, attributed to HSCA President Curtis Rooney, reads as the following:
“HSCA applauds the Congress for working in a bipartisan manner to pass the FDA Safety and Innovation Act (S. 3187). We believe that this legislation will help address the prescription drug shortage issues confronting the healthcare supply chain, hospitals, and American patients and enhance the ability of the supply chain to track and recall faulty medical devices using a Unique Device Identifier (UDI).
“The development of a unique device identification system for medical devices is critical to patient health. Provisions in this legislation that would set deadlines for the release of these crucial regulations is important to the health and safety of patients. UDI will help ensure that patients can be quickly located and notified in the event of a device recall and that they do not continue to use devices that may be harmful to their health.
“HSCA supports Congress in its efforts to require drug companies to provide FDA early notification of anticipated drug shortages. With advanced notification provisions included in this law, FDA can act to relieve the pressures on the supply chain that lead to shortages. This approach will help ensure that patients and hospitals have continuous access to potentially life-saving treatments that patients rely on for their health and wellbeing.”
Related Articles on HSCA:
HSCA Praises House for Passage of Prescription Drug User Fee Legislation
HSCA Agrees With GAO Reporting Finding Lack of Transparency Raises Medical Device Prices
