More drugs are hitting the recall list these days. As CNN Money reports, the number of recalls hit 1,742 last year--that's an increase of 309 percent over 2008.
"We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," says Bowman Cox, managing editor of the Gold Sheet, a trade pub that analyzes FDA data. "That's a meaningful development."
More than 1,000 of the 2009 recalls involved drugs from Advantage Dose, a repackager that has since shut down. But even if Advantage Dose's numbers are removed, recalls still grew by 50 percent year over year. And the pace appears to be continuing, Cox says; from January to June, the FDA counted 296 recalls. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he adds. "That's still a very high rate of recalls."
Experts tell CNN Money that poor manufacturing controls are partly to blame. Substandard raw materials, bad labeling, poor packaging and contamination are leading problems. In addition, the FDA has had new leadership over the past couple of years, and Commissioner Margaret Hamburg has pledged to boost enforcement.
And then there's the intense competition for first-to-file status among generics makers. The first copycat drug maker to get FDA approval wins 180-day marketing exclusivity, a major prize. Cox notes that the rush to get to market could lead to mistakes: "So they get the application...but they could still have problems down the road if they haven't really understood the optimum way to make that drug."
- read the CNN Money piece