According to the FDA’s first Annual Report on Drug Shortages – required by Klobuchar’s legislation – the FDA made major progress in preventing shortages and reducing the number of new shortages in 2013
In its report, the FDA specifically highlights Klobuchar’s early notification provision, which was signed into law in 2012, as critical in fighting drug shortages
WASHINGTON, D.C. – After U.S. Senator Amy Klobuchar (D-MN) passed legislation to help fight drug shortages, the Food and Drug Administration (FDA) reported that it successfully prevented at least 140 drug shortages in 2013 and helped reduce the number of new shortages by over 65%.. According to the FDA’s first Annual Report on Drug Shortages – required by Klobuchar’s legislation, from January 1 to September 30, 2013 the FDA made major progress in preventing drugs shortages and reducing the number of new shortages from 117 to 38. In its report, the FDA specifically highlights Klobuchar’s early notification provision, which was signed into law in 2012 as part of The Food and Drug Administration Safety and Innovation Act, as critical in fighting drugs shortages.
“With work from patients, hospitals, and pharmacists across Minnesota, we managed to get these commonsense reforms to help prevent drug shortages signed into law,” Klobuchar said. “This report confirms that provisions like early notification are already reducing the number of incidents and protecting patients from life threatening shortages of critical drugs. I will continue to push reforms that will help ensure that patients in Minnesota and across the country have access to the medications they count on.”
Klobuchar has long fought to prevent drug shortages to help protect patients and save lives. The Food and Drug Administration Safety and Innovation Act, signed into law in 2012, includes a bipartisan drug shortages agreement Klobuchar helped forge that require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage. The bill also contained Klobuchar’s provisions directing the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them.