Transforming FDA LogoFDA this week announced the formation of a 15-member committee to advise it on how to improve communication regarding risks and benefits of medical devices and other products the agency regulates. The committee is based on a recommendation from the Institute of Medicine. There's no question that the agency needs to do a better job in this regard. The public has mistakenly come to understand that a product with FDA approval should have zero risk. This perception is part of why the agency has taken such heat over products that have proven too risky after approval. The question is whether the goal of clear, concise, consistent, and contextual communication can be achieved by a committee...
June 6th, 2007
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Transforming FDA LogoDr. Steven Nissen, head of the Cleveland Clinic's department of cardiovascular medicine, has made a name for himself as an FDA watchdog in recent years. He was one of the first to raise alarms about safety issues for Vioxx and drug-eluting stents. Today's Boston Globe has an interesting read on why Nissen has become such a prominent voice. His critics say it's because he's angling to become the next FDA commissioner. (Beltway insiders expect Andrew von Eschenbach, a friend of the Bush family, to step down when President Bush leaves office.) His critics seem to fear...
June 5th, 2007
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Today's Boston Globe has a piece about the rise of Inverness Medical Innovations, Inc. (Waltham, MA), which has made an incredible eight acquisitions so far this year, including yesterday's puchase of Cholestech Corp. for $326 million. Inverness is, among other things, the market leader in home pregnancy tests. (Cholestech's products measure cholesterol and other signs of heart disease.) As part of the drive to keep medical costs down, inexpensive point-of-care tests such as those made by Inverness can be a powerful tool. As demand for these tests rises, expect Inverness to become even more of a force.
June 5th, 2007
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Not according to some analysts. However, companies in recent years have embarked on efforts to educate consumers about options that could enhance their health (and more obviously, help promote their product). For example, Zimmer has placed ads about its Gender Knee implant on TV, in newspapers, and has even been spotted on MySpace, a social networking site. Medtronic Inc. also unleashed a $100-million ad campaign for its defibrillator product six months ago. While analysts are pointing out the effects of ads can't necessarily be immediately seen, a Medtronic spokesman has said the company has received positive feedback from patients and doctors, and that the number of responses has "exceeded" their expectations.
June 4th, 2007
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More than two years after the notorious defibrillator recall, companies continue to experience the lingering effects. After a decrease in defibrillator implants in 2006, Medtronic Inc. announced yesterday that it will be cutting between 350 and 500 jobs in its cardiac rhythm division. According to the Star Tribune, the job cuts will be nationwide, but employees were also be given the chance to either transfer to other parts of the company, retire early, or accept voluntary buyout packages. While Guidant Corp. was mainly responsible for the highly publicized defibrillator recall, Medtronic pulled 87,000 of its devices off the market in February 2005.
June 1st, 2007
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A federal judge refused to grant Shelhigh Inc.'s request that the government release the tissue-based devices it seized last month because of concerns about sterility. Judge William Martini said he could not rule whether Shelhigh's devices met GMP standards without holding a hearing, reports the Star-Ledger of Newark, NJ. He said that hearing will come as soon as possible. Shelhigh executives say the company's future is in jeopardy if it cannot export the seized devices. The judge urged both sides to try to reach a settlement, using a mediator if possible. But, as we predicted, Shelhigh has hired Larry Pilot to help in its defense. Companies who seek out Pilot often do so because he is willing to take on FDA in court. Shelhigh also rejected FDA's request to recall devices it already shipped to hospitals. That's not an indicator of being willing to settle, either.  
May 31st, 2007
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James Mazzo, president and CEO of Advanced Medical Optics, told the media that the recall of its contact lens solution is not related to a manufacturing problem or a contamination issue, reports the Associated Press. Rather, he says, the problem more likely stems from users handling their lenses improperly. But he didn't have a definitive answer, nor a sense of the recall's financial impact on the firm. Meanwhile, the New York Times speculates that this recall, combined with Bausch...
May 30th, 2007
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FDA announced late last week that Advanced Medical Optics (Santa Ana, CA) has voluntarily recalled its Complete MoisturePlus Multi Purpose Solution for soft contact lenses. Consumers who use the solution should stop using it immediately and discard it. They should also replace their lenses and storage container. As a result of a Centers for Disease Control investigation, the solution has been linked to a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. It found that users of the solution were seven times more likely to develop the infection than those who do not use it. A similar scenario last year caused Bausch...
May 29th, 2007
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A Minnesota-based plastic surgeon is developing a diagnostic tool with the intention of detecting a silicone breast implant rupture. The mention of the technology is buried deep within a New York Times story about FDA's requirements for patients with silicone breast implants to undergo routine MRI's and the disagreement about this condition shared by many plastic surgeons. About four pages into the piece, a small paragraph talks about this interesting technology. According to the read more >>
May 24th, 2007
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Legal action that takes place in the drug industry is an indication of areas where device companies need to be cautious. Although the device industry is quite adamant (as it should be) about the differences between drugs and devices, litigation is one area where we're beginning to see similarities. Experts at device conferences during the past year have emphasized that we're next and that it would be wise to look at what's happening to drug companies to see if these problems are present in your organization. Yesterday evening, the Associated Press reported about a subpoena received by the drug company Amgen Inc. over promotional "and other" activities. While not much details were given, it noted that the subpoena sought documents from Amgen's sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications. Experts at a...
May 23rd, 2007
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