Key provisions from Congressman Carney's Drug Shortage Prevention Act included in Food and Drug Administration Reform Act of 2012
WASHINGTON — U.S. Congressman John Carney (D-DE) praised the House’s 387 – 5 passage of H.R. 5651, the Food and Drug Administration Reform Act of 2012, which contains several key provisions of Congressman Carney’s Drug Shortage Prevention Act. On May 10th, the bill passed the House Energy & Commerce Committee unanimously. Last week, the Senate passed similar legislation, which included the same provisions of Congressman Carney’s bill, by a vote of 96-1.
“The problem of prescription drug shortages gets worse every year. Americans must have access to the critical drugs they need to stay healthy and fight back against deadly diseases,” said Congressman Carney. “The changes that I have proposed will ensure that more of these critical drugs are produced by manufacturers and reach the patients who need them. I thank my colleagues in the House for taking up this important legislation. I hope that we can send the bill to President Obama for his signature in the near future.”
A number of key provisions from Congressman Carney’s drug shortage prevention bill are included in the Food and Drug Administration Reform Act passed today by the House, including:
• Expedited review of any application seeking approval of a critical drug and any request by a manufacturer of a critical drug to approve a change to the manufacturing process or facilities of that drug in order to mitigate or prevent a shortage.
• Improved regulation of critical drugs to ensure that, at each stage of the regulatory process, the status of drugs as critical drugs is taken into consideration.
• Development of improved communications protocol between offices within FDA responsible for approving and regulating critical drugs and offices of FDA responsible for identifying and addressing critical drug shortages.
• Requirement that FDA communicates any new regulatory concern identified about a critical drug to the office within FDA responsible for identifying and addressing critical drug shortages.