Late Breaking News
Progress Notes April 2010
- Categorized in: April 2010
THE FIRST PHASE OF THE FDA’S TRANSPARENCY INITIATIVE is designed to explain agency operations, how it makes decisions, and the drug approval process. The first phase consists of a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. The curriculum is accessible via a link on the FDA Web site. The curriculum includes questions and answers about the agency and the products it regulates; short videos that explain various agency activities; and conversations with agency personnel about the work of their office. In addition, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each of these sessions will be announced on the FDA Web site. In one of her first acts after assuming the office last spring, FDA Commissioner Margaret A Hamburg, MD, announced the formation of an internal task force to develop recommendations for enhancing the transparency of the FDA’s operations and decision-making processes.
A PILOT CONTRACT WAS AWARDED TO HARVARD PILGRIM HEALTH CARE, INC to develop a pilot of the FDA’s Sentinel System, which will use automated health care data to evaluate medical product safety. Reports filed by hospitals, health care professionals, and industry account for much of information that the FDA relies on regarding medical product safety. For a variety of reasons, these reports may be incomplete or not filed in a timely manner. The Sentinel System is designed to provide FDA with the ability to analyze information collected during the course of routine health care, such as data from electronic health record systems, administrative and insurance claims databases, and medical registries. The one-year contract with Harvard Pilgrim, based in Wellesley, MA, includes four renewable years for a total of $72 million. Under the terms of the contract, Harvard Pilgrim will establish a coordinating center that will operate as a scaled down version of the Sentinel System. This center, or “mini-Sentinel,” will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality.
TWO RESEARCHERS FROM THE NATIONAL INSTITUTE ON DRUG ABUSE have been awarded the White House Office of National Science and Technology Council’s Presidential Early Career Award for Scientists and Engineers (PECASE). NIDA grantees Bruce J Hinds, PhD, and Gonzalo E Torres, PhD, received their awards during a ceremony at the Commerce Building in Washington, DC. Hinds, associate professor of chemical and materials engineering at the University of Kentucky, was recognized for his work to improve the delivery of drugs that treat nicotine dependence through a novel skin patch. Torres, assistant professor of neurobiology at the University of Pittsburgh School of Medicine, was cited for his research on cellular and molecular regulation in the brain and its relationship to psychiatric disorders and drug addiction.
VA HAS HIRED FIVE NEW FEDERAL RECOVERY COORDINATORS, bringing the total number to 20. Recovery coordinators are responsible for coordinating care for the most seriously injured servicemembers. The Federal Recovery Coordinators program was created in 2007 to assist servicemembers, veterans, and their families with access to care, services and benefits provided by VA, DoD, other federal agencies, states, and the private sector. Currently, the coordinators work with 419 of the most seriously injured servicemembers and veterans. The program is administered by VA and operated jointly with DoD. The program’s clients include servicemembers and veterans who are receiving acute care at military treatment facilities, diagnosed with specific injuries or conditions, considered at risk for psychological complication, or likely to benefit from a recovery plan.
VA HAS WON TOP NATIONAL HONORS from the independent Institute for Safe Medication Practices for its excellence in preventing medication errors. Called the “Cheers Awards,” it honors individuals, organizations, companies, and government agencies that set a high standard for keeping patients safe and improving the process of using medication. For more than a decade, VA’s health care system has given hospital patients a bar code wristband. The bar code contains the patient’s unique identifier information. Nurses scan the wristband and the patient’s electronic health record displays the patient’s medical information. Then the nurse scans a corresponding code on a drug package before giving the medication to the patient. This ensures the right medications go to hospital patients at the right time, in the right dose. This year marks VA’s milestone of 10 years scanning bar codes on patient wristbands and drug packages to ensure safe and effective treatment. In August 1999, VA first deployed bar code software throughout its medical centers to detect potential errors at the point where medications are given to patients. Since then, VA has administered more than 1.3 billion doses of medication through this automated system.
CDC DIRECTOR DR THOMAS FRIEDEN RECENTLY ANNOUNCED seven new members of his leadership team. Six of the positions being filled are in the Office of the CDC Director while the other is the director of the new Center for Global Health. The appointments announced were: Donna Garland, Associate Director for Communications; Dr Harold Jaffe, Associate Director for Science; Bill Nichols, Chief Operating Officer; Dr Robin Ikeda, Deputy Director, Office of Noncommunicable Diseases, Injury and Environmental Health; Dr Rima Khabbaz, Deputy Director, Office of Infectious Diseases, Dr Stephen Thacker, Deputy Director, Office of Surveillance, Epidemiology and Laboratory Services; and Dr Kevin De Cock, Director, Center for Global Health.
NEARLY $1 BILLION IN RECOVERY ACT AWARDS have been slated to help health care providers advance the adoption and meaningful use of health information technology and train workers for the health care jobs of the future, according to HHS officials. The awards will help make health IT available to over 100,000 hospitals and primary care physicians by 2014, and train thousands of people for careers in health care and information technology. This Recovery Act investment will help grow the emerging health IT industry which is expected to support tens of thousands of jobs ranging from nurses and pharmacy techs to IT technicians and trainers. Over $750 million of the HHS grant awards are part of a federal initiative to build capacity to enable widespread meaningful use of health IT. Another $225 million will be distributed through DOL to help train 15,000 people in job skills needed to access careers in health care, IT, and other high-growth fields.
NCCAM HAS WELCOMED FIVE NEW MEMBERS TO ITS NATIONAL ADVISORY COUNCIL. The council serves as the principal advisory body to NCCAM, the lead federal agency for complementary and alternative medicine research. The new members are: Adam Burke, PhD, Dr Gary Curhan, Dr Steven DeKosky, Susan Folkman, PhD, and Janet Kahn, PhD. The council is composed of physicians, scientists, licensed CAM practitioners, and members of the public who contribute their time and expertise over a four-year term. Like other NIH advisory councils, members meet three times per year, offering advice and recommendations on prioritization, conduct, and support of research, including research training and communication of evidence-based health information.
NIA HAS COMMITTED $36.7 MILLION TO SUPPORT AGING RESEARCH over the next five years. The funding will go to expand and support and expand NIA’s Centers on the Demography and Economics of Aging. The centers form a network of universities and organizations leading innovative studies on the characteristics of the aging population. The awards, which include some support from the American Recovery and Reinvestment Act, renewed support for 11 centers and established three new ones. Each NIA Demography Center has its own set of disciplinary specializations, although research conducted at the different centers is often interrelated. The three new centers are: Center on the Demography of Aging, Duke University, which will focus on biodemography; Hopkins Center for Population Aging and Health, Johns Hopkins University, which will focus on disability and intergenerational support; and the Center for Aging and Policy Studies, Syracuse University, which will focus on behavioral responses to aging, public policy, and gerontology education.