The number of drug shortages has quadrupled in the past five years, forcing doctors and pharmacists to delay or ration care, as life-saving medications remain in short supply, according to the Government Accountability Office on Monday.
There were 456 drug shortages in 2012, and the trend was continuing, with another 361 drug shortages reported by the middle of 2013, according to the GAO report.
Drug-quality issues and manufacturing delays or shutdowns related to quality accounted for 70 percent of drug shortages reported between Jan. 1, 2011, and June 30, 2013, according to the report.
The scarcity of certain drugs in the market has jeopardized the ability of care providers to stabilize trauma victims, control pain during surgery, and treat heart disease, said Marcia Crosse, GAO’s director of health care, at a congressional hearing on the report.
“The large number of shortages reported to the FDA suggests the market is still at risk of supply disruptions,” Crosse said.
The Food and Drug Administration is responsible for overseeing drug quality-problems and working with manufacturers to remedy shortages. Congress granted the FDA greater oversight powers in 2012 after it passed the Food and Drug Administration Safety and Innovation Act, requiring manufacturers to notify the agency of shortages and requiring the agency to maintain shortage databases and create action plans to solve them.
GAO credited the FDA with making progress in its goal to increase the availability of drugs, particularly generics, in the face of shortages. The FDA’s efforts to get drugs back on the market include regulatory flexibility and expedited reviews of new drugs.
While the number of overall drug shortages remains high, the number of new drug shortages is falling. There were 195 new shortages in 2012, down from 255 in 2011.
“Our next task is to understand those longer-duration shortages,” said Douglas Throckmorton, deputy director of regulatory programs at the FDA.
Roughly 64 percent of new drug shortages — 722 of the 1,132 reported to the FDA between January 2007 and June 2013 — lasted less than one year. But 14 percent lasted more than two years, and some as long as four or more.
GAO recommends that the FDA improve its database of drug shortages and use the information to analyze trends and identify risk factors to prevent future deficiencies.
What We're Following See More »
Writing for an 8-0 Supreme Court on Monday, Justice Clarence Thomas wrote that patent lawsuits "must be brought in the state where the defendant company is incorporated. ... The ruling likely spells an end to the near-monopoly the federal court in the Eastern District of Texas holds in handling patent cases. Plaintiffs for decades have filed suits in that pro-plaintiff district based on a broader interpretation of venue that made suits possible almost anywhere."
Former National Security Adviser to President Donald Trump Michael Flynn will refuse to cooperate with a subpoena from the Senate Intelligence Committee. "Flynn will invoke his Fifth Amendment protection against self-incrimination." Flynn was unlikely to turn over any documents without being granted immunity, as he "has previously sought immunity from 'unfair prosecution.'"
The Trump administration plans to ask a federal court Monday for a second 90-day delay in a lawsuit over Obamacare subsidies. The lawsuit, House vs. Price, revolves around the Obamacare co-payment program, which pays health insurers who partake in the Obamacare exchanges to ensure that people without means can gain coverage without having to pay unaffordable co-payments.
"On Sunday, U.S. President Donald Trump called on the world to isolate Iran," to the delight of his Sunni hosts, Saudi Arabia. Meanwhile, however, on Saturday, "Iranians poured into the streets by the hundreds of thousands to celebrate the re-election of President Hassan Rouhani, whose message of opening up to the West helped him to trounce a hard-line challenger."