More than half of all domestic drug manufacturing plants inspected by the FDA failed inspection last year, a new analysis by Bloomberg revealed. Looking at almost 10,000 inspection records from the last 10 years, the report shows that inspection failures jumped 20 percent from 2007 to 2010, and 80 companies failed more than half of their inspections in that timeframe, according to Pharmalot’s account.
Though the failure rate wasn’t broken down by quality indicators, the trend is worrisome. These domestic sites are being inspected at a rate of .9 times per year; plants overseas are only getting checked out by FDA once every three.
Meanwhile, Roger Bate of the American Enterprise Institute looked at samples manufactured in a series of emerging economies and found that drug compounds manufactured in Africa had the most variability, followed by China, Vietnam and other emerging markets. A higher variability can signal drug quality problems. In a statement, Bate said that loopholes in regulation of these emerging markets make the difference in quality among producers hard to determine.
“China is an unusual country—they have some good producers and some shoddy producers. Some of those problem suppliers have to do with the fact that in China you don’t have to be registered as a drug producer in order to sell your chemicals or compounds—instead, you can register as raw chemical producer and the regulations are less strict,” Bate said.
But drug pedigree today, said PhRMA spokesperson Mark Grayson, is not as clear cut as borders. “Saying something is made somewhere is no guarantee that it is made there. For instance, a country produces some raw chemicals for a compound, then ships it to Ireland, and they might combine five more ingredients there and stamp it ‘Made in Ireland.’ Then it could be shipped somewhere else,’ Grayson said. ‘The end result is that even though [the label on] a drug says it was made somewhere, the component parts are made all over the world.”
–Kate Petersen, PostScript blogger