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Food And Drug Administration Moves Towards Greater Openness
The Food and Drug Administration is taking steps towards greater openness. The Associated Press reports that FDA Commissioner Margaret Hamburg "announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months." Deputy Commissioner Joshua Sharfstein will head the task force, which will represent all of the FDA"s major divisions as well as its law enforcement branch. It will hold two public meetings with the first on June 24. "The FDA has long operated under strict confidentiality rules," the AP reports, and in opening up information, one sensitive issue will be what to do with unpublished clinical trial data from drug manufacturers. Despite such concerns, "Hamburg said she believes the need for secrecy may have been taken too far, and is harming the FDA"s credibility within the medical community and among consumers" (Alonso-Zaldivar, 6/2).
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Washington State Drops Budget Provision That Would Have Cut Medicaid Pharmacy Payments
Washington state lawmakers this week eliminated a budgetary proposal that would have reduced Medicaid payment rates to pharmacies to the lowest levels in the country, the AP/Spokane Spokesman-Review reports. The provision would have reduced the payment rate from 86% to 80% of the average wholesale price of branded drugs. It had been approved by the state House and Gov. Chris Gregoire (D) and was intended to address the state"s $9.3 billion shortfall for the current fiscal year.The state"s Department of Social and Health Services moved to make the rate change on April 1, but pharmacy operators and a person living with HIV/AIDS brought a suit in federal court in Tacoma, Wash., and a judge blocked the change. According to the judge"s order, the plaintiffs likely could prove that their best interests had not been sufficiently considered and that the proposal would diminish the quality of Medicaid care in the state. Walgreen had stated that if the rate change occurred, 44 of its 111 stores in the state would no longer be able to fill Medicaid prescriptions. Other pharmacies made similar arguments. The state prepared an argument on behalf of the rate cut, but later decided against it.Along with eliminating the payment reduction, state legislators added a provision that a DSHS analysis is required before rates can be lowered in the next budget, as well as one placing a 2% cap on any future rate cuts. DSHS spokesperson Jim Stevenson said the agency had not started to analyze what would be required to get a rate cut approved, but added, "I think we"re at a stage where we"re going to have to do it soon if we want to get ready for July 1," the start of fiscal year 2010 (AP/Spokane Spokesman-Review, 5/13).
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Sanofi-aventis And Regeneron Announce Results From Phase 2 Study With Aflibercept (VEGF Trap) In Advanced Ovarian Cancer
Sanofi Aventis (Euronext: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that advanced ovarian cancer patients with recurrent symptomatic malignant ascites (SMA) receiving aflibercept (VEGF Trap) in a randomized, placebo-controlled Phase 2 study experienced a statistically significant improvement in the primary study endpoint, mean time to first repeat paracentesis (removal of fluid from the abdominal cavity), versus placebo control. Symptomatic malignant ascites is an abnormal build-up of fluid in the abdominal cavity in patients with advanced cancer.
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Food And Drug Administration Moves Towards Greater Openness

The Food and Drug Administration is taking steps towards greater openness. The Associated Press reports that FDA Commissioner Margaret Hamburg "announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months." Deputy Commissioner Joshua Sharfstein will head the task force, which will represent all of the FDA"s major divisions as well as its law enforcement branch. It will hold two public meetings with the first on June 24. "The FDA has long operated under strict confidentiality rules," the AP reports, and in opening up information, one sensitive issue will be what to do with unpublished clinical trial data from drug manufacturers. Despite such concerns, "Hamburg said she believes the need for secrecy may have been taken too far, and is harming the FDA"s credibility within the medical community and among consumers" (Alonso-Zaldivar, 6/2). The New York Times reports that for years the FDA "has withheld information about drugs and medical devices from the public when their makers cite trade secrecy - even in cases where the agency suspects that the products are causing serious illness or death" and that "researchers have long complained that keeping such information secret can harm the public" (Harris, 6/1). Meanwhile, USA Today notes that the new task force "is seeking suggestions from employees, stakeholders and the public about how the agency can become more transparent." It also listed several key questions the FDA is pursuing (Rubin, 6/3). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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