Obama orders FDA to tackle drugs shortage

The Obama administration on Monday ordered the US Food and Drug Administration to step up its efforts to stem the growing drug shortage crisis in the US and called for new legislation requiring companies to report looming shortfalls.

An unprecedented 211 prescription drugs were in short supply in the US last year, and more than 200 have already been reported so far this year, according to the FDA. Drug companies have blamed supply chain and manufacturing problems for the shortages, which have inspired calls for the FDA to be given new powers to tackle shortfalls.

“Demand for medications is growing while capacity for production is not,” said Kathleen Sebelius, secretary of the Department of Health and Human Services. “We can’t stand by and watch Americans go without medicines they count on.”

The executive order calls on the FDA to broaden its approach to reporting shortages of certain prescription drugs, provides additional staffing so the agency can accelerate reviews of manufacturing sites and drug suppliers, and requires increased collaboration with the US Department of Justice to clamp down on price gouging.

Last month, a US congressional committee requested documents from five “grey market” drug companies that buy and sell drugs in short supply to find out how they are acquiring the drugs and how much profit they are making from selling them to hospitals and pharmacies. The committee said that one company was selling a drug to treat leukaemia for nearly $1,000 per vial when the normal price was $12 per vial.

Hospitals in the US have said they are having difficulty acquiring cancer drugs and in some cases have had to ration medications or alter courses of treatment. A July survey by the American Hospital Association found that 99.5 per cent of hospitals reported one or more drug shortages in 2011 and, of these, 82 per cent of hospitals reported that the shortages resulted in delayed patient treatment.

The Obama administration released a report on Monday that found drug shortages were due to a lack of growth in manufacturing facilities, while demand for drugs has increased. Its survey found that 43 per cent of shortages were due to lack of manufacturing capacity, while shipping delays and shortages of raw ingredients were also important factors.

Ms Sebelius also called on Congress to move forward with proposals that would require drug companies to report prescription drug shortages to the FDA.

Ms Sebelius acknowledged on Monday that the order does not give the FDA new authority but that it should give greater attention to the issue and that, with industry co-operation surrounding disclosure of production problems, shortages should decline.

“We can’t fix the capacity issue,” Ms Sebelius said. “Demand on these drugs has risen dramatically.”