Drug shortages ease but remain serious problem

Patients who can't get the drugs they need because they're in short supply will not be impressed by the news, but the problem of drug shortages has so far been less severe this year than last.

Through August, there were 123 new drugs in short supply, about 33% fewer than a year earlier, reports NBC News. In the second quarter of this year, there were 211 active shortages, down from 246 reports of active shortages in the 2011 quarter.

FDA officials ascribe the improvement to efforts the agency made after President Obama issued an executive order last year that the FDA should get early reports from companies about potential shortages so it can work on them. After that the agency began importing some unapproved drugs from other countries that could serve as temporary substitutes, approved some new facilities more quickly to make replacements and worked with companies to find ways to deal with problems in the least disruptive way.

For example, in June, Hospira ($HSP) sent out a warning that some of its prefilled cartridges containing pain medications had been overfilled. Rather than requiring it to recall all of the potentially affected devices, which would have resulted in immediate shortages of some drugs, the FDA and the company told doctors to visually inspect the cartridges for fill levels and use them if there was no danger of overdosing patients.

"These were drugs that were medically necessary," Valerie Jensen, associate director of the FDA's drug shortage program, tells the news group. "We worked with the company to make sure that the overfill lot was recalled."

Even so, manufacturing issues at Hospira and other drugmakers have allowed some shortages to drag on. Teva Pharmaceutical Industries ($TEVA), Sandoz, the generics division of Novartis ($NVS), and Boehringer Ingelheim's Bedford Laboratories--lost 30% of their capacity when the FDA expected them to upgrade their manufacturing, a fact pointed out by a House committee that in June criticized the FDA for being too aggressive in its oversight. The agency shot back that it had to take steps when poor-quality manufacturing put patients at risk and sometimes that means companies must close plants to make upgrades.

And new problems lead to new shortages. Problems the FDA found in July with mold at a Sanofi Pasteur plant in Canada has led to a shortage of tuberculosis vaccine BCG and set the stage for a possible shortage of the bladder cancer drug ImmuCyst.

- read the NBC News story

Related Articles:
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FDA to Congress: Agency not the cause of drug shortages
House report blames FDA actions for drug shortages
FDA turns to Merck on Sanofi cancer drug shortage
Mold may lead to Sanofi cancer drug shortage

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