New Drug Shortages Decline in U.S. as Regulators Raise Scrutiny

Feb 10, 2014 3:24 pm ET

Feb. 10 (Bloomberg) -- New drug shortages decreased in the U.S. as the Food and Drug Administration stepped up its vigilance on the issue, government auditors said.

There were 195 shortages of medicines reported in 2012, a 24 percent decline from the previous year and the first time since 2006 the U.S. saw a reduction in new drug shortages, the General Accountability Office said today in a report. There were 73 new shortages through June 30, 2013, the office said.

The number of current shortages has increased every year since 2007 and remains high, the agency said, with 456 reported in 2012.

“From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful outcomes for patients of all ages,” the FDA said in a letter to Congress accompanying the report.

Manufacturing issues cause most shortages, with suppliers slowing or halting production when they experience quality problems, according to the report. A law passed in July 2012 gave the FDA new powers to address shortages, including requiring manufacturers to give the agency six months’ notice if they plan to discontinue drugs or halt production.

The agency also was given flexibility to consider the impact of shortages as it regulates manufacturers, and expedite approvals of new drugs that can replace medicines in shortage.

--Editors: Andrew Pollack, Bruce Rule