Surgery News - February 2009 - (Page 10) 10 OPINION FEBRUARY 2009 • SURGERY NEWS EDITORIAL MedSun: A Ray of Hope for the FDA n a previous editorial, I was critical of the Food and Drug Administration (“Truth Decay at BY LAZAR J. GREENFIELD, M.D., FACS the FDA,” November 2005, p. 6). Since then, leadership changes and restructuring have occurred in response to critical reviews from the Institute of Medicine and the FDA’s own science board. But we still have a combination of starvation funding and mounting public health responsibilities. The result is a persistently lumbering, bureaucratic, disaster-in-waiting. Little wonder that lead paint on imported toys, heparin contaminated by crude but cheap production abroad, and Escherichia coli food contamination not only escaped detection but were handled abysmally. Why can’t the FDA get its act together? FDA inspectors’ reports are handwritten and slowed by layers of administration, reports of product dangers are not rapidly compared and analyzed, and old computers can’t distinguish between shipments of road salt and table salt. (For details, visit www.fda.gov/ohrms/ dockets/ac/07/brief ing/20074329b_02_00_ index.html.) But instead of fixing the problems, FDA officials spent $300,000 on a public relations firm. Instead of directly hiring the one they wanted, they used a minority firm to circumvent the bidding regulations. That Native Alaskan group was supposed to I subcontract the deal to the Washington firm the FDA wanted, but after the Washington Post discovered the ruse, the FDA suspended the contract, and ordered an investigation (New York Times, Oct. 5, 2008). Public outrage over such events is having an effect. Last year, the Bush administration added $275 million in FDA funding to the agency’s budget request for FY 2009, and passage of the FDA Amendments Act of 2007 (FDAAA) increased user fees paid by industry for timely reviews while expanding the FDA’s authority to review drugs and medical devices. The cozy relationship between industry and the FDA remains problematic, however, as dependence grows on industry’s contributions. One bright spot is the FDA’s MedSun program, which was started in 2002 by the agency’s Center for Devices and Radiological Health. This program trains risk managers to report online problems that cause serious injury, illness, or death, as well as near misses. It was legislated because health care facilities have traditionally ignored their legal requirement to report medical device problems. MedSun includes 350 sites with separate sub- How can you accelerate upper and lower GI recovery? Find Out More on CDRH/FDA Sites Device Listing and Establishment Registration. Users can search for information on medical devices in commercial distribution, and establishments engaged in device manufacture or preparation (www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfRL/rl.cfm). MAUDE (Manufacturer and User Facility Device Experience). Users can search for reports of adverse events involving medical devices (www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfMAUDE/ search.CFM). Medical Device Safety Web Site. This site includes published safety tips, alerts, and recalls (www.fda.gov/cdrh/ medicaldevicesafety/). Product Classification. Users can find the classification of a device and the regulations it is subject to (www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfPCD/ classification.cfm). Warning Letters. This database contains all Warning Letters issued since 2003 and some issued before (www.fda.gov/foi/warning.htm). Important Safety Information WARNING: FOR SHORT-TERM HOSPITAL USE ONLY ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support & Education (E.A.S.E.TM) Program may use ENTEREG. • ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG • There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established Reference: 1. ENTEREG Prescribing Information. Exton, PA: Adolor Corporation; 2008. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM http://www.fda.gov/cdrh/medicaldevicesafety/ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm http://www.fda.gov/foi/warning.htm
Table of Contents Feed for the Digital Edition of Surgery News - February 2009 Surgery News - February 2009 Contents The 20/20 Vision ICD-10 Looms News From the College: MedPAC Flak Oncology: Best for Breast General Surgery: Weighty Problem Surgery News - February 2009 Surgery News - February 2009 - Contents (Page 1) Surgery News - February 2009 - Contents (Page 2) Surgery News - February 2009 - Contents (Page 3) Surgery News - February 2009 - Contents (Page 4) Surgery News - February 2009 - The 20/20 Vision ICD-10 Looms (Page 5) Surgery News - February 2009 - The 20/20 Vision ICD-10 Looms (Page 6) Surgery News - February 2009 - The 20/20 Vision ICD-10 Looms (Page 7) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 8) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 9) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 10) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 11) Surgery News - February 2009 - Oncology: Best for Breast (Page 12) Surgery News - February 2009 - Oncology: Best for Breast (Page 13) Surgery News - February 2009 - Oncology: Best for Breast (Page 14) Surgery News - February 2009 - Oncology: Best for Breast (Page 15) Surgery News - February 2009 - Oncology: Best for Breast (Page 16) Surgery News - February 2009 - Oncology: Best for Breast (Page 17) Surgery News - February 2009 - Oncology: Best for Breast (Page 18) Surgery News - February 2009 - General Surgery: Weighty Problem (Page 19) Surgery News - February 2009 - General Surgery: Weighty Problem (Page 20)
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