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JNJ Faces Flood of Lawsuits for Unauthorized Medical Device PDF Print E-mail
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Sunday, 25 March 2012 06:54

The weekly round-up of failed trials, missed targets, and other business mishaps.

Johnson & Johnson sold a vaginal mesh implant for three years before the U.S. Food and Drug Administration approved the device. That device, used to treat pelvic organ prolapse and urinary incontinence, is now the subject of more than 550 lawsuits by women who say it injured them. J&J’s Ethicon unit introduced the device, Gynecare Prolift, in March 2005. The FDA, however, did not become aware of the device until 2007, when J&J was seeking approval for a follow-on device, the Prolift +M.

The FDA cleared both devices in May 2008, unaware that J&J had already been selling the original Prolift for the prior three years. J&J believed it could market the Prolift without approval because it was so similar to an already approved device, the Gynecare Gynemesh. Morgan Liscinsky, an FDA spokeswoman, said in an e-mail to Bloomberg, that the FDA has concluded unauthorized distribution began without appropriate clearance. The decision by Ethicon to distribute Prolift without human testing raises questions about the FDA’s current approval process for medical devices, which lets companies introduce products without human testing if the agency decides they are similar to devices already for sale, or so-called predicates. A J&J spokesman says that the company abided by relevant FDA guidance when it introduced the original Prolift in 2005.

New Jersey biotech Neurologix filed for Chapter 7 bankruptcy liquidation listing assets of $1.2 million and debt of $12.9 million. The company was unable to raise cash to continue development of its gene therapy for Parkinson’s disease, for which it had reported positive mid-stage clinical data in the summer of 2011 and had hoped to start a late-stage trial in 2012.

Days after announcing it was halting a late-stage trial of varespladib after it was shown to be ineffective as a treatment for acute coronary syndrome, Anthera Pharmaceuticals said it would eliminate 45 percent of its workforce and reallocate resources to developing blisibimod, currently being evaluated in a mid-stage trial as a treatment for lupus. Anthera had 38 employees at the end of 2011, according to Reuters.

Shares of Cardiome Pharma plunged 40 percent after Merck told the Canadian biotech it was discontinuing further development of an oral formulation of vernakalant due to an assessment of the regulatory environment and projected development timeline. The intravenous formulation of vernakalant is approved in the European Union and Latin America under the tradename Brinavess as a treatment for atrial fibrillation. Cardiome said that as a result of the discontinuation of the oral vernakalant program, it would reduce its annual operating expenses by approximately $11 million, or about half of the current cash burn.

Pfizer has agreed to pay $3.3 million to Oregon for deceptive marketing claims related to its antibiotic drug, Zyvox. According to Oregon’s attorney general, Pfizer used unreliable and unsubstantiated claims to promote Zyvox though it lacked any documented evidence to support its assertions. Pfizer’s sales representatives were also accused of distributing copies of flawed clinical studies throughout Oregon to support the marketing claim that Zyvox was a better choice than a cheaper, generic antibiotic. The money will reimburse Oregon’s State Accident Insurance Fund and the Department of Corrections for previous Zyvox purchases. Some of the money will also go to fund a new program for consumer education and efforts to teach consumers about proper use of antibiotics.

Nearly 18 months after launching Psoriasis 360 Facebook page, the Janssen UK unit of Johnson & Johnson is closing down the page after numerous comments were taken down due to mentions of specific drugs and, in some cases, offensive and profane language was used. The decision speaks to the underlining debate over how much the pharmaceutical industry should embrace social media. Last year Facebook revoked the right of drugmakers to disable posted comments, causing many within the industry to question their ability to maintain and manage their Facebook pages. “As a U.K. company, we comply with strict rules particularly in relation to communication with members of the public,” writes Janssen, which markets the Remicade psoriasis treatment, in an email to Pharmalot. “These rules mean that whenever a post on this page mentions a specific drug by name, or talks about the efficacy of a particular treatment, we have to ask for it to be changed, or pull it. We have found ourselves removing a larger and larger proportion of posts, stifling worthwhile discussions.”

Teva received a letter last week from the U.S. Food and Drug Administration Office of Prescription Drug Promotion that reprimanded the company for developing materials that were false and misleading. The letter was in regards to a panel display at the American Academy of Neurology as well as a website that promoted Teva’s multiple sclerosis treatment, Copaxone. According to the letter, the display panel and website, caused “violations [that] are concerning from a public health perspective, because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence of substantial clinical experience. The display panel at the AAN meeting boasted that Copaxone has demonstrated 20 years of proven safety, shown results after an average of 22 years with relapsing remitting multiple sclerosis, and that its Expanded Disability Status Scale scores remained stable after an average of 15 years on therapy. But, according to the FDA, those claims overstated the safety and efficacy of drug because the clinical studies section of the product labeling only include data for up to three years in duration.

 

 
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