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FDA Ups Recent Recalls

The US regulatory agency recalled 54 percent more drugs from the second to third quarters of 2011.

By | November 9, 2011

FLICKR, CANDY

The US Food and Drug Administration's increased oversight of US drug manufacturing plants has led to a big jump in the number of drug products recalled in the third quarter of this year, according to a report issued by Stericycle ExpertRECALL, a company that tracks such trends. Specifically, the FDA recorded 150 recalls in the third quarter of 2011, up from 97 in the second quarter.

"The FDA has stepped up its oversight of US manufacturing plants and operations," Stericycle ExpertRECALL Vice President for Recalls Mike Rozembajgier wrote in an email to FiercePharma Manufacturing. "And with the US Government Accountability Office's recent call for the agency to intensify its efforts to track and regulate overseas pharmaceutical manufacturing, we can expect the FDA to intensify its oversight even more."

Very few (less than 7 percent) of the third-quarter recalls were made because the product in question had the potential to cause serious injury or death, but more than half were the result of possible adverse events that were serious enough to have irreversible consequences, according to the report.

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Avatar of: Jo Ellen Wall

Jo Ellen Wall

Posts: 1457

November 29, 2011

BioJobBlog recently posted that this recent rise in recalls coincided with a record-breaking amount of drug approvals (35 new pharmaceuticals were approved just last week). Are these recalls proportional to the amount of new approvals, or are drug recalls becoming an exponentially rising trend? www.drugrecalls.com just posted regarding the latest Vioxx settlement ($950 million and change- the smallest of the recent pharmaceutical settlements posted). Reading that post, I would think that pharmaceutical companies would eventually step up their "voluntary recalls" without any FDA initiative, to minimize their settlement losses, if for nothing more.

Avatar of:

Posts: 0

November 29, 2011

BioJobBlog recently posted that this recent rise in recalls coincided with a record-breaking amount of drug approvals (35 new pharmaceuticals were approved just last week). Are these recalls proportional to the amount of new approvals, or are drug recalls becoming an exponentially rising trend? www.drugrecalls.com just posted regarding the latest Vioxx settlement ($950 million and change- the smallest of the recent pharmaceutical settlements posted). Reading that post, I would think that pharmaceutical companies would eventually step up their "voluntary recalls" without any FDA initiative, to minimize their settlement losses, if for nothing more.

Avatar of:

Posts: 0

November 29, 2011

BioJobBlog recently posted that this recent rise in recalls coincided with a record-breaking amount of drug approvals (35 new pharmaceuticals were approved just last week). Are these recalls proportional to the amount of new approvals, or are drug recalls becoming an exponentially rising trend? www.drugrecalls.com just posted regarding the latest Vioxx settlement ($950 million and change- the smallest of the recent pharmaceutical settlements posted). Reading that post, I would think that pharmaceutical companies would eventually step up their "voluntary recalls" without any FDA initiative, to minimize their settlement losses, if for nothing more.

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