| November 4, 2009 | News for the biotech, medical device, drug and food regulatory profession |
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| Drugs & Biologics |  |  |
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- IVAX, Omnicare settle kickback allegations regarding Risperdal
IVAX Pharmaceuticals and Omnicare agreed to resolve allegations that they solicited kickbacks in exchange for encouraging doctors to prescribe Johnson & Johnson's antipsychotic Risperdal to patients at nursing homes, the Justice Department said. Omnicare, which will pay $98 million, denied wrongdoing despite the settlement. Reuters
(11/3)  
| Health Care in Transition | | |
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- Senate sunshine provisions would shed light on doctor-industry ties
The Senate Finance Committee has included in its health reform proposal so-called sunshine provisions that would promote transparency among drug and medical device makers that pay doctors for consultations and speeches. AdvaMed backed the sunshine initiative, and the Pharmaceutical Research and Manufacturers of America said any laws on payment disclosures should not imply that doctor-industry ties are inappropriate. NYTimes.com
(11/3)
- Opinion: Patient safety should be addressed in biogenerics measure
Congress should ensure that patient safety and medical efficacy are prioritized in any health reform measure that would allow the use of generic biotech drugs, Dr. David B. Nash of Thomas Jefferson University's Jefferson School of Population Health writes in a letter to the editor. Rather than only debating market exclusivity for biogenerics, lawmakers should also specify rules on testing these drugs and consider requiring postmarket surveillance to avoid "unintended consequences" that compromise patient safety, Nash writes. The Hill
(11/3)
- Reid hints health reform may not pass this year
Senate Majority Leader Harry Reid, D-Nev., said Tuesday that the Senate debate on the health reform bill may not begin until December, indicating that Congress may miss President Barack Obama's year-end deadline for passing the proposal. Reid's spokesman, however, said the lawmakers have "unprecedented momentum" to get health insurance reform done before the year ends. Yahoo!/The Associated Press
(11/3)
| Biotechnology | | |
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- FDA clears PerkinElmer's genetic screening processor
The FDA has granted 510(k) clearance to PerkinElmer for its genetic screening processor designed to help public health laboratories screen newborns for genetic, hematologic or metabolic conditions. The GSP tool can enable laboratories to run multiple tests on very small blood samples. The Boston Globe (free registration)
(11/3)
| Food & Dietary Ingredients | | |
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| Medical Devices | | |
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- FDA unveils guidance for H1N1 virus diagnostic test makers
The FDA has released a set of guidelines designed to help makers of H1N1 flu virus diagnostic tests apply for emergency use authorization. "During this declared public health emergency, manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an [Emergency Use Authorization]," the agency said. Clinica (subscription required)
(11/3)
- Group: Medicare cuts would reduce community-based imaging
The increase from 50% to 90% of the assumed Medicare equipment use rate as part of the 2010 Medicare Physician Fee Schedule would reduce community-based imaging and limit imaging services to large hospitals, which could lead to delayed diagnoses of serious conditions, the American College of Radiology said. "Many hospitals are not equipped to handle the substantial influx of patients that could result from the inevitable closure of rural and suburban imaging facilities caused by these cuts," one of the group's officials said. HealthImaging.com
(11/3)
| FDLI Items | | |
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The second edition features brand-new practical guidance from industry insiders on these watershed events: FDA Final Guidance on Good Reprint Practices; Cephalon ($413 million), Eli Lilly ($1.4 billion); Fraud Enforcement and Recovery Act; Supreme Court's ruling in Wyeth v. Levine. Learn more. Order your copy.
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Attend Introduction to Medical Device Law and Regulation to learn, refresh or update yourself on FDA regulations, including product approvals, labeling, promotion and general regulatory compliance issues, Nov. 17 and 18
By attending Introduction to Medical Device Law and Regulation, you will obtain a clearer understanding of the essential elements of medical device regulation. Nov. 17 focuses on the legal framework and premarket requirements; Nov. 18 addresses the QSR, adverse events and inspections. Register.
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