FDA says industry must take responsibility for supply chain security
The US Food and Drug Administration has called on lawmakers to grant the agency more regulatory powers so that it can place the onus on industry to tighten pharmaceutical supply chain security. In testimony before the Senate Committee on Health, Education, Labor and Pensions (HELP), FDA Deputy Commissioner for Global Regulatory Operations and Policy Deborah […]
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Michele Bachmann And The HPV Vaccine Bounty
Now that the Minnesota congresswoman and Republican presidential candidate Michele Bachmann has contended that the Merck Gardasil vaccine for combating HPV may have been responsible for mental retardation, she is encountering some pushback. This is not surprising, given that such comments feed into the ongoing controversy over vaccine safety, in general. To date, there is […]
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FDA, Compounded Animal Drugs & Overreaching
Should the FDA have the authority to stop pharmacies from using bulk ingredients to compound prescription meds for non-food producing animals, such as dogs and horses? In an interesting case, a federal court judge has ruled the agency does not have this authority but, moreover, attempted to overstep its bounds in a potentially draconian way […]
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Pfizer Cuts Jobs In Germany: Is It Payback?
There is certainly nothing surprising that Pfizer or any other large drugmaker is planning to cut jobs. A few hundred here. A few thousand there. The drumbeat is been sounding for a few years now. And so a story that Pfizer is eliminating about 500 positions in Germany, at first blush, may not generate much […]
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Novartis Plans More Cuts And Consolidation
During an investor presentation the other day, Novartis execs spent considerable time not only discussing recent financial performance and pipeline progress, but also the many steps taken to save money. These include a raft of cuts across various divisions around the globe and, in the US, consolidating some operations, such as shifting some research from […]
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Deadly Drug Contamination Inevitable, FDA Tells U.S. Senate
Fatal drug contamination like a 2008 incident involving Baxter International Inc. (BAX)’s blood thinner Heparin that sickened and killed hundreds is inevitable unless the agency gets enhanced inspection and recall powers for non-U.S. factories, a top regulator said. Another crisis is “not a matter of if, it’s a matter of when,†Deborah Autor, the Food […]
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Most Protocols Are Amended During Clinical Trials
Nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars, according to an analysis by the Tufts Center for the Study of Drug Development. Specifically, the review found that completed protocols across all clinical […]
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Daiichi Unit Warned By FDA Over Manufacturing
Yet another unit of Daiichi Sankyo has elicited the wrath of the FDA. The agency issued a warning letter to its Luitpold Pharmaceuticals subsidiary for “significant†and repeated violations at a Long Island, New York, manufacturing plant. The facility was inspected last winter and was shut down for a month in April to address the […]
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Merck Is On The Defensive Over Gardasil, Again
These are trying times for the Merck c-suite. For the past week, their Gardasil vaccine has been in the news every day, but not for very good reasons. First, Texas Governor Rick Perry is attacked by his rivals for the Republican presidential nomination for accepting Merck donations leading up to his controversial decision to unilaterally […]
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J&J Pays $85M Fine Over Natrecor Marketing
The Scios unit of Johnson & Johnson Scios has agreed to pay an $85 million fine and pleaded guilty to a msidemeanor for misbranding the Natrecor acute heart failure drug. The drugmaker was accused of providing labeling that “lacked adequate directions for use†between 2001 and 2005. The move comes two years after prosecutors began […]
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