FDA said it will alert doctors to problems associated with two imaging agents that are injected into patients' veins before their hearts are viewed via echocardiography, an ultrasound procedure, Reuters reports. The agency is investigating reports that GE's Optison and Bristol-Myers Squibb's Definity are associated with deaths and severe cardiopulmonary reactions. It is possible the products will be required to carry a "black box" warning, the strongest kind. Definity is currently on the market; Optison was recalled in 2005 because of manufacturing issues and is scheduled for relaunch soon. Only a small percentage of patients who receive echocardiograms are injected with either product.
October 9th, 2007
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Medtronic has been trying to get regulators and clinicians to believe that its drug-eluting stent, Endeavor, should be approved and used over existing products because it is safer. However, clinical data revealed Friday throw a wrench into the claim, Bloomberg News reports. Those data show Endeavor to be more associated with blood clots than Boston Scientific's Taxus. (However, this did not translate into deaths and heart attacks, which were lower for Endeavor patients than Taxus ones.) This is not the best time for such news. Endeavor will be discussed by an FDA advisory panel on Wednesday, after which the panel will decide whether to recommend it for approval. Even if Endeavor does get through FDA, the new data gives Boston Scientific marketing ammunition.
October 8th, 2007
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Siemens, the German conglomerate that makes medical imaging systems, among other things, was fined about $284 million by a German court over accusations of some employees making bribes to secure contracts, reports the Associated Press. That brings to an end one of several investigations. This one focused on the company's failing to report the proceeds to German authorities for tax purposes. Several of the firm's top officials resigned over the scandal.
October 5th, 2007
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A study published in the New England Journal of Medicine suggests that drug-eluting stents might be more effective than their bare-metal counterparts. As part of the study, 7.4% of patients that had the DES needed another procedure within two years to restore blood flow versus the 10.7% rate for those who had a bare-metal stent implanted. And after three years, 5.5% of the patients with the DES had died compared to 7.8% of patients with the bare-metal stents. In other stent news, Medtronic is expecting FDA to approve its Endeavor stent by the end of this year. According to analysts, the device has a safety profile that puts it above J&J and Boston Scientific.
October 4th, 2007
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Since its founding in 1992, the Global Harmonization Task Force has come up with a number of ideas about how to bridge the gaps among worldwide regulations and how to involve nations that don't have much (if any) regulatory infrastructure. But at its conference, which starts today in Washington, DC, it plans to take some steps to make these things a reality. So said Larry Kessler, director of CDRH's Office of Science and Engineering Laboratories and the current GHTF chairman, at a press conference yesterday afternoon. FDA's Quality System Regulation and ISO 13485, the medical device quality standard used by the EU, Canada, and other countries, are as close as they have ever been to harmony, he said. And now the GHTF is implementing a system by which adverse event reports can be shared around the world in the same format. But perhaps most significantly, he said, a number of nations in Latin America and Southeast Asia will be ready to adopt quality-system schemes in the near future....
October 3rd, 2007
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GE yesterday held an event for press at its GE Global Research facility (where the firm does its basic science before handing it over to a business division for development) in Niskayuna, NY, and I was in attendance, as the research that happens here often ends up in the GE Healthcare portfolio. There were several developments of interest. Two of the most significant: First, GE Global Research and Eli Lilly announced a three-year collaborative research agreement to develop advanced in vitro diagnostics assays that could predict whether a cancer patient will respond to a certain treatment. The agreement covers two Lilly compounds but could be used for other compounds later if the technology works. Success in developing such a diagnostic technology would not only prevent waste from foregoing a treatment that would be ineffective, but could also lead to a much more streamlined clinical research process. If the potential clinical trial population were screened beforehand for likelihood...
October 2nd, 2007
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FDA has come under fire in a new report for not ensuring the safety of the millions of people who participate in clinical trials. According to a New York Times story, HHS inspector general Daniel R. Levinson said that federal health officials rarely audited testing sites and if they did, the inspectors usually arrived after tests were completed.

Of course, there are about 200 inspectors assigned to oversee approximately 350,000 testing sites, so it’d be virtually impossible to police every site. But the report also found that top officials in Washington downgraded the inspectors’ findings most of the time and almost never followed up to see if specified corrective actions were taken.

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October 1st, 2007
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The life sciences industries and regulators need to do a much better job of risk communication, or else the public will completely lose confidence in the healthcare system, three experts said during a luncheon discussion of global economic and health issues at this week's RAPS annual conference in Boston. Bill George, former CEO of Medtronic, Susan Alpert, MD, PhD, chair of the RAPS board, and Bogdan Dziurzynski, president of RAPS, agreed that the way risks and benefits are communicated to patients must be rethought, and that postmarket monitoring and communication efforts need to be greatly expanded. The question is, how to pay for that. Alpert suggested that premarket clearance be rethought of as a "learner's permit" rather than a stamp of approval. It would enable products to come to market quickly in limited applications, and then expand to other applications once more extensive postmarket testing was done and no red flags were raised. However, she said, "regulators are not going...
September 28th, 2007
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Five orthopedics companies have settled with the U.S. Department of Justice over allegations that they may have paid kickbacks to surgeons in return for favoring their hip and knee implants, the Associated Press reports. The five are Biomet, Johnson...
September 27th, 2007
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Transforming FDA LogoPresident Bush today signed the FDA Amendments Act of 2007, which includes the new version of the Medical Device User Fee and Modernization Act, according to a release just sent out by AdvaMed. The law, among other things, extends the user-fee program for another five years (with significant changes in the user-fee structure) and provides incentives for device makers to conduct pediatric studies. This means there will be no disruption of FDA's work. Had the law not been signed before Oct. 1, all FDA staff whose salaries come from the user-fee budget would have had to be laid off.
September 27th, 2007
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