• False medical reports lead to echo-mill conviction [Drug and Device Law]
• Leads for sale in mass tort cases: Actos $450, Yaz $400, Yazmin $400, Ocella $425 [Ron Miller]
• Ninth Circuit: securities suit vs. pharmaceutical company can’t piggyback on allegations of flawed clinical trials [The Recorder]
• Dubious management idea: subordinate policy/legislative advocacy to corporate social responsibility (CSR) department [Susan Crowley/PharmExec]
• “Former Glaxo VP: ‘The Criminalization of the Practice of Law Is Here’” [WSJ interview with Lauren Stevens]
• Given the state’s legal climate, does it really make sense for a big pharmco to retain its headquarters in Pennsylvania? [Ted Frank] Sounds rather appetizing actually: defendant J&J said to have run into Louisiana home cooking [Eric Alexander, D&D Law]
• On the life-threatening shortages of sterile injectables [earlier here, etc.] here’s the official line of Margaret Hamburg’s FDA, as dutifully transcribed by the Times: if “nearly a third of the industry’s manufacturing capacity is off line because of quality issues,” it’s because that capacity had been operating in an recklessly unsafe manner, and it in no way reflects on the FDA’s stringent new GMP regulations on manufacturing processes, with which drug makers could easily comply were they not so inured to putting up with weevils, rust and urine on the production line. Note however this significant bit: “The shutdowns have contributed to a shortage of critical drugs, and [loosely state-regulated] compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years,” including a deadly new meningitis outbreak. [Katie Thomas, NYT]

Filed under: FDA, Pennsylvania, pharmaceuticals