MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'decree'. Sat, 03 Sep 2011 02:54:13 +0100 http://www.medworm.com/index.php?rid=4853217&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZdvfQlG4ejw%2F The ‘phantom recall’ scandal last year in which Johnson & Johnson hired contractors to yank over-the-counter meds such as Motrin from store shelves rather than conduct a proper recall prompted congressional hearings and contributed to a consent decree, among many other things. And during one hearing, the FDA agreed to review procedures that allowed the health care giant to, essentially, circumvent agency oversight (back stories here, here and here). Now, though, Darrell Issa, who chairs the House Committee on Oversight and Government Reform, which held those hearings, has written FDA commish Margaret Hamburg to say the agency has failed to take “promised and necessary corrective actions at its San Juan office.” And he complains that he encountered “great ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853217 Mon, 23 May 2011 18:19:57 +0100 4853217 http://www.medworm.com/index.php?rid=4693506&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4zogyJRhrJY%2F Some assignments are more challenging than others. And Denice Torres will certainly have a big mountain to climb now that she is running Johnson & Johnson’s beleaguered McNeil Consumer Healthcare unit, the division responsible for numerous manufacturing gaffes that led to an eye-popping series of product recalls and a spate of troubles for the once-venerable healthcare giant. Since 2009, Torres headed CNS (or central nervous system) for North America Pharmaceuticals for J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit. For two years prior to that post, she was an Ethicon sales and marketing vp, and an Ortho McNeil Neurologics marketing vp. She reports to Pat Mutchler, who was recently named company group chair for US over-the-counter and nutritional products (see this)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693506 Fri, 08 Apr 2011 12:20:38 +0100 4693506 http://www.medworm.com/index.php?rid=4658626&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FX_coy97_9ZY%2F Perhaps there is a strategy at work here. Once again, Johnson & Johnson has issued a product recall. In the scheme of things, this is a very modest one - exactly one lot of Tylenol 8-Hour Extended Release Caplets, which amounts to 34,000 150 bottles, according to a statement the health care giant issued yesterday afternoon. Given the overwhelming number of recalls over the past year - tens of millions of products, including over-the-counter meds, hip replacement devices, syringes and contact lenses, among others - perhaps the J&J team has figured out that the public, investors and consumers alike, has tired of hearing about such things and will start ignoring the ongoing problems. Of course, J&J is obligated in some ways to release such info. But the events have become so ro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658626 Wed, 30 Mar 2011 11:56:41 +0100 4658626 http://www.medworm.com/index.php?rid=4627015&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4tFBEcAGy0Q%2F Never mind a consent decree. Genzyme continues to have manufacturing problems at its Allston Landing, Massachusetts facility. The biotech today disclosed that a lot of its Fabrazyme med, which is used to treat Fabry’s disease, was rejected for failing to meet quality standards and the move will further limit supplies to patients who are already suffering from rationing. “As you know, we have been operating with very limited inventory of Fabrazyme. Because inventory is so limited, loss of this specific lot of Fabrazyme will have an impact on some patients in the coming months. For some patients, this may mean delaying scheduled infusions immediately; for some patients, it may mean missing one or more infusions altogether over the next few months. All regions will share the impac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627015 Wed, 23 Mar 2011 22:18:21 +0100 4627015 http://www.medworm.com/index.php?rid=4570755&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdawHSkf9zpU%2F After months of serious manufacturing problems, Johnson & Johnson has entered into a consent decree with the FDA for three separate facilities that have been responsible for most product recalls over the past year. Moreover, two execs - McNeil Consumer Healthcare vp of quality Veronica Cruz and the vp of operations for OTC products, Hakan Erdemir - were also named as civil defendants. The plants, all of which are run by the McNeil Consumer Healthcare unit, are located in Fort Washington and Lancaster, Pennsylvania, and Las Piedras, Puerto Rico. As part of the decree, which is expected to run five years, J&J is required to destroy all drugs made at the facilities since 2009, J&J must hire outside experts to develop remediation plans and follow strict timetables for meeting va... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570755 Thu, 10 Mar 2011 21:06:51 +0100 4570755 http://www.medworm.com/index.php?rid=4489978&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fm5Z4_CQibSM%2F After chasing Genzyme around the table for several months, Sanofi-Aventis has finally reached a deal. Originally, the drugmaker offered $69 a share, but as you know, is paying $74 in cash, or roughly $20 billion, plus an unusual contingent value rights (CVR) that will be priced depending on various factors, such as fixing manufacturing problems and whether the Campath leukemia med is approved for multiple sclerosis. And so the CVR could require additional payouts of up to $4 per CVR later. Or maybe not. As for strategy, Sanofi ceo Chris Viehbacher has pooh-poohed stock buybacks and talked up the value of pursuing Genzyme and its biologics, an area of keen interest to big pharma. Then again, Genzyme is saddled with ongoing manufacturing difficulties that resulted in not only a consent decre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489978 Wed, 16 Feb 2011 16:34:00 +0100 4489978 http://www.medworm.com/index.php?rid=4372246&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIzSqDJiZYhw%2F File this under ‘if at you first you don’t succeed…’ After being rejected last month by the National Institutes of Health in a bid to override the patent on a Genzyme drug that is in perpetually short supply, a pair of Fabry’s disease patients are now petitioning the FDA to insist that overseas stock of the med is first made available to US citizens. The move comes amid ongoing difficulties Genzyme has encountered in producing sufficient supplies of Fabrazyme due to severe manufacturing problems that began in 2009. These prompted a $175 million fine, a consent decree and a takeover bid from Sanofi-Aventis. Existing patients, meanwhile, are subject to inadequate rationing and newly diagnosed patients are unable to receive any meds. To rectify the situation, som... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372246 Wed, 19 Jan 2011 15:25:39 +0100 4372246 http://www.medworm.com/index.php?rid=4245602&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTPdP0IO_UZo%2F For those struggling to keep track of all the Johnson & Johnson recalls and misdeeds over the past year, the FDA web site is a treasure trove of information. The agency offers a handy-dandy tally of all of the millions of bottles of over-the-counter medications recalled this year as well as a dirty laundry list of manufacturing problems at its McNeil Consumer Healthcare unit. To wit, there are nine - count ‘em, nine - separate listings for extensive recalls this year of such venerable products as Tylenol, Mylanta, Motrin, Rolaids and Benadryl, which means the tally is incomplete (see this). How so? The ‘phantom recalls’ that were disclosed by the House Committee on Oversight and Government Reform took place last year (see here and here) Elsewhere, the FDA lists no fe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4245602 Thu, 09 Dec 2010 13:58:15 +0100 4245602 http://www.medworm.com/index.php?rid=4220454&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fxqi0xobah4I%2F The possibility that the FDA may take more severe action against Johnson & Johnson may be more likely. After all, the agency last month issued a 483 enforcement report, which detailed all sorts of problems at the healthcare giant’s Las Piedras facility in Puerto Rico, mostly to do with quality control and following written procedures (take a look). Yet some violations cited were also found in a previous 483 report stemming from FDA inspections at the same facility last January and February. Being a repeat offender, especially after being warned not to do so amid multiple and serious manufacturing issues at this plant and another in Fort Washington, Pa., does not bode well for Johnson & Johnson. Consequently, “we see increased risk of a consent decree or seizure, eithe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220454 Wed, 01 Dec 2010 14:44:46 +0100 4220454 http://www.medworm.com/index.php?rid=4106058&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fp0__1ar8-tk%2F Hello, everyone, and a very good morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling assorted short people off to the local schoolhouse and preparing for the usual round of meetings and deadlines. Same with you? Of course. So to prepare, here are a few items of interest. Hope your day goes well and do stay in touch… Savient Pharmaceuticals Fails To Find A Buyer (Bloomberg News) Boehringer Prices New Bloodthinner At $6.75 A Day (Reuters) Celgene Scales Back Expansion Plan (NJ.com) Walgreen May Sell Its PBM Business (Bloomberg News) Insurer Pilots Cancer Care Reimbursement For Oncologists (PharmaTimes) NICE May Not OK Simponi For Rheumatoid Arthritis (PharmaTimes) Amgen Earnings Beat Estimates Despite Shrinking Sales (Bloomberg N... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106058 Tue, 26 Oct 2010 12:03:44 +0100 4106058 http://www.medworm.com/index.php?rid=3599740&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl5rzkQWb88Y%2F The beleaguered biotech, which agreed to pay $175 million for its sins, disclosed the basics yesterday. These include a remediation plan that will take up to three years to complete and if milestones aren’t met, the FDA can require a fine of $15,000 a day, for each affected drug, until everything is on track. Then, there is five years of oversight and annual reports (see the consent decree here). Meanwhile, Genzyme will continue to ship Cerezyme and Fabrazyme, which are made, filled and finished in its Allston Landing, MA, plant, as well as Thyrogen, which is filled and finished there. In the US, Thyrogen distribution will be based on medical necessity until another facility is available. But Genzyme has to move fill and finish operations out of the Allston plant for those three meds... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599740 Tue, 25 May 2010 19:58:11 +0100 3599740 http://www.medworm.com/index.php?rid=3399174&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfnGrxrJ2nEU%2F After months of manufacturing problems involving viral contamination and even bits of trash in some of its products, the beleaguered biotech says the FDA intends to take enforcement action that will “likely result” in a consent decree. And so a “third party” would inspect and review its operations for an extended period, and Genzyme would have to pay what is currently an unspecified fine (here is the Genzyme statement). Just the same, Genzyme expects product shipments to continue. The biotech makes and sells Cerezyme to treat Gaucher disease and Fabrazyme for treating Fabry disease, as well as Myozyme for Pompe disease. Talks will be held with the FDA about its Thyrogen treatment for thyroid cancer patients. Its troubles began last summer when its Allston Landing, M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3399174 Wed, 24 Mar 2010 13:40:48 +0100 3399174 http://www.medworm.com/index.php?rid=2167481&cid=t_197885_87_f&fid=34825&url=http%3A%2F%2Fwww.wesleyjsmith.com%2Fblog%2F2009%2F02%2Fhere-we-go-again-italian-government.html We have discussed the case of Eluana Englaro, who has been unconscious since an auto accident in 1992. Her father won a court order to remove her feeding tube. But for awhile, all hospitals and nursing homes refuse to participate in her dehydration. Mr. Englaro then found a facility that would, but now the Italian Government has passed a 60-day reprieve preventing the dehydration. From the story: The Italian government today passed a decree to force-feed a woman who's been kept alive artificially since a 1992 car accident, ignoring a letter from the country's head of state, who said he will not sign the law.A failure to intervene "would make me feel responsible for not coming to the rescue of a person whose life is in danger," Prime Minister Silvio Berlusconi told reporters in Rome after a... Secondhand Smoke blogs http://www.medworm.com/rss/comments.php?id=2167481 Fri, 06 Feb 2009 17:05:00 +0100 2167481 http://www.medworm.com/index.php?rid=1709057&cid=t_197885_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F08%2F14%2Fdiagnosis-by-government-decree%2F Today, Furious Seasons brings us the silence of the U.S. Food and Drug Administration’s (FDA) Thomas Laughren, director of the FDA’s psychiatry products division, on the issue of pediatric bipolar disorder diagnosis. By approving medication for pediatric bipolar disorder, the FDA has, by government decree, sanctioned a brand new diagnostic category out of the blue. The FDA also suggests that there is widespread agreement about pediatric bipolar disorder and little controversy about the wholesale prescription of the same kinds of medications prescribed for adults (despite there being absolutely zero long-term studies done on pediatric populations to see whether there are developmental effects of these medications on a child’s growing brain and body): Steven Hyman, a Ha... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1709057 Thu, 14 Aug 2008 20:00:37 +0100 1709057 http://www.medworm.com/index.php?rid=775570&cid=t_197885_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F140027970%2F $500 million later, the drugmaker is finally free of the shackles of the US Attorney. In a brief statement this afternoon, Fred Hassan announced the May 20, 2002, consent decree was dissolved, following a petition filed in federal court. The decree, a legacy of former ceo Dick Kogan, involved numerous violations of FDA Good Manufacturing Practices at facilites in New Jersey and Puerto Rico, where dozens of meds are made. The problems cast a dark cloud over Schering-Plough, which was struggling with ways to replace revenue lost to generic Claritin, and hastened the end of Kogan’s stormy tenure. The dissolution, which Fred called an “important milestone,” isn’t surprising, though. In January 2006, the drugmaker announced it had completed all 212 significant steps an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=775570 Thu, 02 Aug 2007 18:07:35 +0100 775570