Late Breaking News
- Categorized in: July 2009 Issue
RICHARD PAZDUR, MD, A NOTED ONCOLOGIST at the Food and Drug Administration, was recognized last month by the world’s largest cancer professional society. The American Society of Clinical Oncology presented Dr. Pazdur with its Special Recognition Award for his achievements in cancer drug development and his “outstanding service to the oncology community.” Dr. Pazdur joined the FDA in 1999, and was named director of the Office of Oncology Drug Products when that office was established in 2005. As part of his duties, Dr. Pazdur coordinates oncology activities across all FDA product centers and ensures collaboration among the FDA, the National Cancer Institute, and both public and private cancer organizations. Clinical trial design and drug development of anti-cancer agents in advanced colorectal cancer are Dr. Pazdur’s main research interests. He has performed numerous phase 1, 2, and 3 and adjuvant therapy trials in his work to treat the disease.
THE FOOD AND DRUG ADMINISTRATION last month announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process. To support the efforts of the task force, the FDA held a June 24, 2009, public meeting to solicit recommendations on how the agency can make more available, useful, and understandable information on its activities and decisions. The task force will be chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., and will include center directors, the associate commissioner for regulatory affairs, chief scientist, and the chief counsel. The task force will endeavor to: seek public input on transparency issues; make recommendations to FDA on how to better explain its operations,; identify information FDA should provide about specific products; identify barriers to transparency; and recommend legislative or regulatory changes designed to improve FDA’s relationship with the public.
The establishment of the task force follows President Obama’s Jan. 21, 2009, memorandum directing executive agencies to find new ways of making information available to the public rapidly and in a form that is easily accessible and user-friendly.
THE DEPARTMENT OF VETERANS AFFAIRS has awarded a $38.3 million contract to the Walsh Construction Company of Chicago to construct an Ambulatory Care Center for the VA Pittsburgh Health Care System. The project will provide outpatient services at the H.J. Heinz Division in a two-story, 117,000-square-foot structure, with a connecting corridor to the existing community living center. The new facility will provide primary care, physical rehabilitation, audiology, dental care, outpatient pharmacy, and patient education. The construction contract also provides for the renovation of the community living center, demolition of two other buildings, site excavation and grading, construction of new roads, parking lots and walks, and landscaping. The VA Pittsburgh Healthcare System serves the Veteran population throughout the tri-state area of Pennsylvania, Ohio, and West Virginia.
ATTORNEY WILL A. GUNN, A RETIRED AIR FORCE COLONEL,took the oath of office last mont has General Counsel of the Department of Veterans Affairs following his recent Senate confirmation. Gunn assumes the helm of an office with a nationwide staff of more than 700 employees, including 460 attorneys. The General Counsel ensures the faithful execution of the laws, regulations, and policies that VA administers. The General Counsel’s interpretations on legal matters further VA’s mission of service to the nation’s Veterans, with written opinions on adjudications and appeals involving Veterans’ benefits under laws administered by VA. Operating through seven professional staff groups in Washington plus 22 regional counsel offices across the United States, the office provides VA representation before administrative and judicial forums, offers formal and informal legal and ethics advice, and drafts and advocates legislation affecting Veterans.
Gunn, an attorney who at the time of his nomination represented military members and Veterans in private practice in northern Virginia, retired from the Air Force in 2005, where he served as a colonel in the Judge Advocate General’s Corps. In 2003, he was named the first chief defense counsel in the Department of Defense’s Office of Military Commissions, building a defense team and supervising defense activities for detainees selected for trial before military commissions to ensure they received effective representation.
THE NATIONAL INSTITUTES OF HEALTH RECEIVED approximately 20,000 applications for Challenge Grants, a new program under the American Recovery and Reinvestment Act. This large number of applications is approximately equal to the total number of applications NIH receives in one of the agency’s three major review rounds each year. The Challenge Grant program is designed to spur new areas of research and trigger an influx of research dollars into communities across the nation. NIH requested applications on topics in fifteen broad scientific areas the agency believes will benefit from a jumpstart or in which scientific challenges need to be overcome. They include bioethics, translational science, genomics, health disparities, enhancing clinical trials, behavioral change and prevention, and regenerative medicine. The Center for Scientific Review will check the applications for compliance and review them in a two-phase process. Reviewers with expertise in the specialized topic areas were recruited to do the first phase reviews. Their reviews and the applications will be further assessed by one of about 30 study sections comprising researchers who will focus on overall significance and impact. CSR typically reviews 16,000 applications with the help of about 8,000 reviewers in each of the three main yearly review rounds. Including Challenge Grants and other ARRA grants, CSR will assess about 40,000 applications this round with about 28,000 reviewers. Scores and summary statements will be available in August 2009. Challenge Grant awards will be issued by September 30, 2009.