FDA takes more steps to curb drug shortages
On Thursday, FDA took a number of steps to prevent shortages of drugs and biologics and to improve the agency's response when there are shortages. The agency issued a proposed rule seeking to expand to all manufacturers -- including those of biologics and those of drugs for which there are multiple manufacturers -- a requirement to notify FDA six months in advance of a possible shortage. Currently, only manufacturers that are the sole source of a drug must notify the agency in advance of a possible shortage. According to FDA, the number of drug shortages fell to 117 in 2012 from 251 in 2011 following a 2011 executive order that first implemented the early notification requirement. The agency said it was able to prevent 282 shortages in 2012 because of early notification. Comments are due Jan. 3, 2014. ...