- Email: [email protected]
New AGA President outlines goals
Gastroenterology News continued
FDA Seeks to Increase Access to Information on Xenotransplantation, Gene Therapy Trials
T
he Food and Drug Administration (FDA) issued a proposed rule in January that would make information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation publicly available. Under the proposed rule, the FDA would provide public access to most of the research design and safety information about these types of studies, while continuing to withhold confidential business information or personal information related to study participants. FDA Commissioner Jane E. Henney called the action “an important
New AGA President Outlines Goals
T
he AGA’s new president expressed confidence in an organization he described as “robust and dynamic.” Jon Isenberg, M.D., Professor of Medicine at the University of California at San Diego, took the reins of the AGA in December due to the illness of President Thomas Brasitus. Isenberg has served in a number of AGA leadership roles, including editor of the Selected Summaries Section of this journal and, most recently, chair of the AGA Council. He noted that the AGA’s strength is caused in large part by the active participation of its membership, coupled with a strong dedicated national office. The annual AGA meeting remains the world’s premier gastroenterology meeting, boasting representation from more than 50 countries and the premier fundamental and clinical scientific presentations. Moreover, Isenberg said, the extraordinary quality of the journal Gastroenterology makes it the highest rated gastrointestinal journal. Isenberg is committed to maintaining the strengths of these 2 key 786
step in ensuring greater public confidence in these revolutionary therapeutic technologies.” Both gene therapy and xenotransplantation hold great promise, Henney said, but they also could pose a risk to the individuals who have volunteered to participate in the studies. “Our proposal will ensure that the public is fully informed as we investigate these new public health opportunities and challenges,” she stated. The proposal would also ensure that the FDA’s policies for public access to this information are compatible with those of other government agencies that oversee research in gene therapy and xenotransplantation. Much of the information that would be disclosed about gene therapy trials under the proposal is already
publicly discussed in open meetings of the Recombinant DNA Advisory Committee of the National Institutes of Health. Similarly, information about xenotransplantation trials will also be publicly available through the Secretary’s Advisory Committee on Xenotransplantation, which is being assembled by the Department of Health and Human Services. Under usual procedures, there is a 90-day public comment period on this proposal. Written comments may be submitted to: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 10-61, HFA-305, Rockville, Maryland 20852 (e-mail: fdadockets@oc. fda.gov). These comments will be considered in the development of any final rule.
elements within the AGA’s portfolio and, if at all possible, making them even stronger. In addition, Isenberg said, one of his goals is to further enfranchise the AGA membership, particularly the younger members. “In this fastpaced world, it is important that we develop the tools and methods whereby we can hear from, and respond to, the membership efficiently and effectively,” he explained. “The AGA wants to be able to understand the issues, concerns, and problems that confront our constituencies and develop methods that deal with them successfully. Further, we need to communicate the many AGA activities and our many successes, such as those that occur on Capitol Hill and at the NIH, to the membership.” Isenberg expressed concern about existing manpower issues, particularly the shortage in the number of young physicians who choose to pursue academic careers in gastroenterology. “We appear to be meeting the increased national need for clinical gastroenterologists,” he explained. “However, there is a glaring shortfall in the
influx of young physicians and scientists entering either clinical or basic academic tracks. This substrate is necessary to teach future gastroenterologists and to advance the science. The AGA, and other societies, have to develop methods that attract young people to the excitement, challenge, and enrichment of a career in academic gastroenterology.” Isenberg is also looking to expand the AGA’s international scope. He plans to explore paths whereby the AGA, when invited by leaders and organizations in other countries (especially nations that are underprivileged), can contribute to improving education and patient care. In addition, Isenberg would like to strengthen the relationship and communications with other national gastrointestinal organizations, so that all of the organizations can work together to improve results for the entire field of gastroenterology at all levels. Stories by Dan Gordon The section editor can be sent suggestions for articles at [email protected]
FDA Seeks to Increase Access to Information on Xenotransplantation, Gene Therapy Trials
T
he Food and Drug Administration (FDA) issued a proposed rule in January that would make information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation publicly available. Under the proposed rule, the FDA would provide public access to most of the research design and safety information about these types of studies, while continuing to withhold confidential business information or personal information related to study participants. FDA Commissioner Jane E. Henney called the action “an important
New AGA President Outlines Goals
T
he AGA’s new president expressed confidence in an organization he described as “robust and dynamic.” Jon Isenberg, M.D., Professor of Medicine at the University of California at San Diego, took the reins of the AGA in December due to the illness of President Thomas Brasitus. Isenberg has served in a number of AGA leadership roles, including editor of the Selected Summaries Section of this journal and, most recently, chair of the AGA Council. He noted that the AGA’s strength is caused in large part by the active participation of its membership, coupled with a strong dedicated national office. The annual AGA meeting remains the world’s premier gastroenterology meeting, boasting representation from more than 50 countries and the premier fundamental and clinical scientific presentations. Moreover, Isenberg said, the extraordinary quality of the journal Gastroenterology makes it the highest rated gastrointestinal journal. Isenberg is committed to maintaining the strengths of these 2 key 786
step in ensuring greater public confidence in these revolutionary therapeutic technologies.” Both gene therapy and xenotransplantation hold great promise, Henney said, but they also could pose a risk to the individuals who have volunteered to participate in the studies. “Our proposal will ensure that the public is fully informed as we investigate these new public health opportunities and challenges,” she stated. The proposal would also ensure that the FDA’s policies for public access to this information are compatible with those of other government agencies that oversee research in gene therapy and xenotransplantation. Much of the information that would be disclosed about gene therapy trials under the proposal is already
publicly discussed in open meetings of the Recombinant DNA Advisory Committee of the National Institutes of Health. Similarly, information about xenotransplantation trials will also be publicly available through the Secretary’s Advisory Committee on Xenotransplantation, which is being assembled by the Department of Health and Human Services. Under usual procedures, there is a 90-day public comment period on this proposal. Written comments may be submitted to: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 10-61, HFA-305, Rockville, Maryland 20852 (e-mail: fdadockets@oc. fda.gov). These comments will be considered in the development of any final rule.
elements within the AGA’s portfolio and, if at all possible, making them even stronger. In addition, Isenberg said, one of his goals is to further enfranchise the AGA membership, particularly the younger members. “In this fastpaced world, it is important that we develop the tools and methods whereby we can hear from, and respond to, the membership efficiently and effectively,” he explained. “The AGA wants to be able to understand the issues, concerns, and problems that confront our constituencies and develop methods that deal with them successfully. Further, we need to communicate the many AGA activities and our many successes, such as those that occur on Capitol Hill and at the NIH, to the membership.” Isenberg expressed concern about existing manpower issues, particularly the shortage in the number of young physicians who choose to pursue academic careers in gastroenterology. “We appear to be meeting the increased national need for clinical gastroenterologists,” he explained. “However, there is a glaring shortfall in the
influx of young physicians and scientists entering either clinical or basic academic tracks. This substrate is necessary to teach future gastroenterologists and to advance the science. The AGA, and other societies, have to develop methods that attract young people to the excitement, challenge, and enrichment of a career in academic gastroenterology.” Isenberg is also looking to expand the AGA’s international scope. He plans to explore paths whereby the AGA, when invited by leaders and organizations in other countries (especially nations that are underprivileged), can contribute to improving education and patient care. In addition, Isenberg would like to strengthen the relationship and communications with other national gastrointestinal organizations, so that all of the organizations can work together to improve results for the entire field of gastroenterology at all levels. Stories by Dan Gordon The section editor can be sent suggestions for articles at [email protected]