Capitol Hill Briefs
Congress passes FDA tobacco bill: President Obama is expected to sign into law legislation authorizing FDA to regulate the manufacturing, marketing and sale of tobacco products. The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) creates a Center for Tobacco Products within FDA, funded by a user fee on tobacco companies (1"The Gray Sheet" March 9, 2009, p. 3). The measure passed the Senate in a 79-17 vote June 11, and an identical version was approved by the House the next day. The Congressional Budget Office anticipates that the act will lower national health care spending for certain medical conditions as smoking declines, but also that government spending in certain other areas will rise as people live longer. HHS Secretary Kathleen Sebelius cast the legislation as part of the administration's larger health care reform effort, calling it "a key part of our plans to cut health care costs" and a "critical piece of a coordinated effort to save lives, lower costs and reduce suffering from heart disease, cancer and other tobacco-related illness.
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A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
REUSE OF DISPOSABLE CARDIAC CATHETERS TARGETED BY FDA in an effort to address safety concerns about reuse of single-use products. The cardiac catheter product area "seems to jump up as one that is an area for us to focus on," Larry Spears, director of the Office of Compliance's Division of Enforcement III in FDA's Center for Devices and Radiological Health, said June 24 at a Food Drug and Law Institute conference held in Washington, D.C.
St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.
Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
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