New bipartisan legislation to address prescription drug shortages
U.S. Representatives John Carney (D-Del.) and Larry Bucshon (R-Ind.) introduced the Drug Shortage Prevention Act Jan. 31, which addresses the scarcity of certain pharmaceutical drugs in the marketplace.
Last year, there were more than 230 different drug shortages, overwhelmingly affecting cancer drugs, anesthesia drugs and nutrition medicines. These drugs are delivered intravenously, as opposed to in a pill form, and the manufacturing process is complex, time-consuming and highly precise. Many of these drugs have only one or two manufacturers in the market, so when a manufacturing problem occurs it can quickly cause a shortage.
The proposed act mandates expedited review of drugs vulnerable to shortages, to prevent them, and it requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. The bill also streamlines communications between the FDA, manufacturers, distributors, providers and patients to ensure that all parties have the information they need to act proactively—instead of reactively—to prevent shortages from occurring.
“Since 2005, the number of drug shortages in the United States has quadrupled, and cancer patients have been disproportionately impacted by this troubling trend,” said Carney. “The Drug Shortage Prevention Act brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients.”
“As a physician, drug shortages for patients who need specialized care is a critical issue that deals directly with the well-being of our citizens,” said Bucshon. “It is vital that we are proactive when it comes to preventing shortages and ensuring access to treatments that save lives and improve health. I am proud to work across the aisle with my colleague from Delaware on an issue of national importance that will truly improve the quality of life for the American people.”
The Drug Shortage Prevention Act is supported by the American Society of Clinical Oncology, the American Society for Parenteral and Enteral Nutrition, AstraZeneca and the Hematology/Oncology Pharmacy Association.