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Drug Safety

Drug Recalls Surge! Or Do They?


Conventional wisdom in the industry suggests that drug product recalls are on the rise, and in fact if you look at the chart that leads off this CNN Money report today, you'd say the 2009 escalation is quite alarming. On closer inspection, as the article points out, many of these recall events are due to the problems of a few manufacturers, such as Advantage Dose.

From 'On Pharma'

With Stock Price Fluctuating, Mylan Fires Back at Post-Gazette


In the latest installment of a continuing saga, Mylan Labs is suing the two reporters from the Pittsburgh Post-Gazette who alleged Quality violations at the manufacturer's Morgantown, West Virginia facility.

From 'On Pharma'

Pharmacy Likely to Blame in Deaths of Polo Horses


Some clarity on the cause of the mysterious deaths of 21 polo horses. A Florida pharmacy has concluded that it used incorrect amounts of active ingredients in mixing a vitamin supplement for the horses.

From 'On Pharma'

A Contrarian View of FDA: Bloated and Inefficient


John Graham of the conservative California think tank, the Pacific Research Institute, just published a research report, Leviathan's Drug Problem, arguing that FDA is overstaffed, overfunded and unproductive. He traces patient wait times for new medicines as contributing to far more loss of life than food contamination.

From 'On Pharma'

FDA, Hospital at Fault in Levine Case, Not Wyeth


Yesterday's  big news was the fact that Wyeth Pharmaceuticals lost its appeal in the precedent setting Wyeth vs. Levine safety labeling case.

From 'On Pharma'

Pfizer Public Service Message a Bit Unappetizing


We appreciate Pfizer's efforts to educate the public on the danger of shady websites peddling countefeit products--but, caution, this one is not for the weak of stomach. Thanks to Drug Channels' Adam Fein for spotting this rat.

--PWT

From 'On Pharma'

You Can't Duct Tape Quality: FDA Issues Consent Decree against Actavis Totowa


In its neverending fight against both poor manufacturing practices and the manufacture and marketing of unapproved drugs, FDA has filed a Consent Decree and expects courts to prohibit Activis’ Totowa, New Jersey facility from further production.

From 'On Pharma'

Star vs. Star: Should Hollywood Be Leading Public Opinion Over Vaccine Safety?


Like it or not, Hollywood shapes perceptions on key societal issues. Jenny McCarthy and Jim Carrey, notably, have been vocal in their questioning of vaccine safety, having a huge influence upon their Hollywood brethren and thus the mainstream public. At least one star, Amanda Peet, is fighting that perception and trying to restore some sanity to the vaccine argument.

From 'On Pharma'

Why the Heparin Story Won't Go Away


Will the High Costs of Analytics Permit Future Cases of Heparin Contamination?


Any crime covered by the press inspires a wave of copycats.  So, it seems, the global heparin supply chain will have to be closely monitored for some time.  Both 2-D NMR and capillary electrophoresis have been recognized as the best ways to assess the purity of heparin. Both are beautiful techniques, and yield a lot of information, but they also require highly experienced analysts and expensive equipment. 

From 'On Pharma'