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Abbott Warned on Quality Issues
The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.
Judge Okays Zimulti Case Revival
A federal judge has granted permission for investors to refile a lawsuit against Sanofi-Aventis over the drug manufacturer's antiobesity drug rimonabant (Zimulti). Sanofi had sought FDA approval to market the drug in the United States but withdrew its application after an FDA advisory panel said that the drug's effects on weight loss could not overcome potential psychological side effects. The investors sued Sanofi in November 2007, saying the French manufacturer failed to disclose data on the medication's link to suicidal behavior, which led to a major loss in Sanofi stock value once the FDA panel made its decision. U.S. District Judge George Daniels dismissed the lawsuit in 2009, saying Sanofi had not acted recklessly, as the plaintiffs contended. But last month, the judge agreed to let the plaintiffs refile their complaint, saying in his ruling that the new complaint “adequately pleads violations of the federal securities laws.”
Generic Makers Claim Big Savings
Generic metabolism drugs accounted for 13% of a total $824 billion saved by use of all generic medications over brand name products in the past decade, according to a report from the Generic Pharmaceutical Association. Metabolism, cardiovascular, and central nervous system drugs accounted for nearly three-quarters of the total $139 billion saved by generics in 2009, the report said. The figures are growing each year as brand-name drugs lose patent protection and lower-cost generic alternatives hit the market, the report said. Two more diabetes medications will come off patent in the next 2 years: Takeda's Actos (pioglitazone) in 2011, and GlaxoSmithKline's Avandia (rosiglitazone) in 2012.
Preventive Training Supported
The Department of Health and Human Services has awarded 15 grants totaling $9 million to train 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received $1 million.
State Backs Coordinated Care
Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.
J&J Discloses Physician Payments
Following in the footsteps of Pfizer, GlaxoSmithKline, and Medtronic, Johnson & Johnson is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. However, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government: PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites. Quarterly updates will give way to semiannual and then annual updates by 2012 for all the divisions. The company will start disclosing payments for medical devices and diagnostics by June 30, 2011, according to a spokesman for J&J.
Abbott Warned on Quality Issues
The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.
Judge Okays Zimulti Case Revival
A federal judge has granted permission for investors to refile a lawsuit against Sanofi-Aventis over the drug manufacturer's antiobesity drug rimonabant (Zimulti). Sanofi had sought FDA approval to market the drug in the United States but withdrew its application after an FDA advisory panel said that the drug's effects on weight loss could not overcome potential psychological side effects. The investors sued Sanofi in November 2007, saying the French manufacturer failed to disclose data on the medication's link to suicidal behavior, which led to a major loss in Sanofi stock value once the FDA panel made its decision. U.S. District Judge George Daniels dismissed the lawsuit in 2009, saying Sanofi had not acted recklessly, as the plaintiffs contended. But last month, the judge agreed to let the plaintiffs refile their complaint, saying in his ruling that the new complaint “adequately pleads violations of the federal securities laws.”
Generic Makers Claim Big Savings
Generic metabolism drugs accounted for 13% of a total $824 billion saved by use of all generic medications over brand name products in the past decade, according to a report from the Generic Pharmaceutical Association. Metabolism, cardiovascular, and central nervous system drugs accounted for nearly three-quarters of the total $139 billion saved by generics in 2009, the report said. The figures are growing each year as brand-name drugs lose patent protection and lower-cost generic alternatives hit the market, the report said. Two more diabetes medications will come off patent in the next 2 years: Takeda's Actos (pioglitazone) in 2011, and GlaxoSmithKline's Avandia (rosiglitazone) in 2012.
Preventive Training Supported
The Department of Health and Human Services has awarded 15 grants totaling $9 million to train 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received $1 million.
State Backs Coordinated Care
Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.
J&J Discloses Physician Payments
Following in the footsteps of Pfizer, GlaxoSmithKline, and Medtronic, Johnson & Johnson is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. However, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government: PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites. Quarterly updates will give way to semiannual and then annual updates by 2012 for all the divisions. The company will start disclosing payments for medical devices and diagnostics by June 30, 2011, according to a spokesman for J&J.
Abbott Warned on Quality Issues
The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.
Judge Okays Zimulti Case Revival
A federal judge has granted permission for investors to refile a lawsuit against Sanofi-Aventis over the drug manufacturer's antiobesity drug rimonabant (Zimulti). Sanofi had sought FDA approval to market the drug in the United States but withdrew its application after an FDA advisory panel said that the drug's effects on weight loss could not overcome potential psychological side effects. The investors sued Sanofi in November 2007, saying the French manufacturer failed to disclose data on the medication's link to suicidal behavior, which led to a major loss in Sanofi stock value once the FDA panel made its decision. U.S. District Judge George Daniels dismissed the lawsuit in 2009, saying Sanofi had not acted recklessly, as the plaintiffs contended. But last month, the judge agreed to let the plaintiffs refile their complaint, saying in his ruling that the new complaint “adequately pleads violations of the federal securities laws.”
Generic Makers Claim Big Savings
Generic metabolism drugs accounted for 13% of a total $824 billion saved by use of all generic medications over brand name products in the past decade, according to a report from the Generic Pharmaceutical Association. Metabolism, cardiovascular, and central nervous system drugs accounted for nearly three-quarters of the total $139 billion saved by generics in 2009, the report said. The figures are growing each year as brand-name drugs lose patent protection and lower-cost generic alternatives hit the market, the report said. Two more diabetes medications will come off patent in the next 2 years: Takeda's Actos (pioglitazone) in 2011, and GlaxoSmithKline's Avandia (rosiglitazone) in 2012.
Preventive Training Supported
The Department of Health and Human Services has awarded 15 grants totaling $9 million to train 55 residents in preventive medicine. Some of the funds come from the American Recovery and Reinvestment Act of 2009. The support goes to accredited schools of public health and medicine and hospital-based residency programs, the agency said. Griffin Health Services Corp., the parent company of Griffin Hospital in Derby, Conn., was awarded the top grant of $1.4 million. The Johns Hopkins Bloomberg School of Public Health received $1.1 million, and the University of California, Davis, received $1 million.
State Backs Coordinated Care
Health care providers in five communities across New Hampshire have agreed with the state's major insurance companies to participate in a 5-year pilot program to encourage collaboration, prevention, and disease management instead of fee-for-service medicine, said Gov. John Lynch (D). Groups of providers in each community will become “accountable care organizations” and thus take responsibility for coordinating health care and preventive services to local residents. Each organization will determine how to spend its budget to achieve quality outcomes and efficiency in its area. “Our current health care system rewards providers for seeing as many patients as possible. We're going to change that. Under this pilot project, we are moving to a system where health care providers will profit from spending time with their patients and keeping them healthy,” Gov. Lynch said in the statement.
J&J Discloses Physician Payments
Following in the footsteps of Pfizer, GlaxoSmithKline, and Medtronic, Johnson & Johnson is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. However, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government: PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites. Quarterly updates will give way to semiannual and then annual updates by 2012 for all the divisions. The company will start disclosing payments for medical devices and diagnostics by June 30, 2011, according to a spokesman for J&J.