ASTROnews: At the Agencies Winter 2009

by Richard Martin, J.D., senior legislative and regulatory analyst

FDA announces IOM study of medical device approval process
In September 2009, the Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to study the premarket notification program, also called the 510(k) process, used to review and clear certain medical devices marketed in the United States. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health will convene its own working group to evaluate and improve the consistency of FDA decision making in the 510(k) process. The IOM study, slated for completion in 2011, will answer two principal questions: Does the current 510(k) process optimally protect patients and promote innovation in support of public health and if not, what legislative, regulatory or administrative changes are needed to achieve the goals of the process? The IOM will now hold two public workshops and will publish a report in March 2011 containing its conclusions and recommendations.

NRC gathering data, increasing awareness of low-level waste disposal issues
ASTRO staff attended a public meeting on October 7, 2009, convened by the Nuclear Regulatory Commission (NRC) to gather information to assess the effect of a lack of access to low-level waste (LLW) disposal facilities on the research community. At this meeting, the NRC sought to identify research that has been impacted and/or stopped because of a lack of disposal options for radioactive sources or materials. The NRC is attempting to raise awareness of the growing disposal problem to develop viable, cost-effective disposal pathways. Participants at the meeting expressed concerns over high costs of available disposal options and limited access to existing disposal sites. Some participants stated that more medical and research facilities are storing LLW – a practice that consumes valuable facility space and requires surveillance and maintenance.

ASTRO continues work to ensure long-term supply of radioisotopes, mitigate pending shortage
ASTRO and other organizations, including the American Association of Physicists in Medicine (AAPM), American Nuclear Society (ANS), American Society of Nuclear Cardiology (ASNC), Nuclear Energy Institute (NEI), SNM, Council on Radionuclides and Radiopharmaceuticals (CORAR) and American College of Radiology (ACR), continue to work together to address the supply and domestic production of isotopes including those used in medicine and research. Safety-related shutdowns of aging reactors in Canada and the Netherlands are resulting in shortages of Mo-99 (degrades to Tc-99m) and may also adversely impact supplies of I-131. In May 2009, the Canadian reactor broke down, and it is not yet clear whether the reactor will ever operate again. Moreover, the reactor in the Netherlands will be taken offline for scheduled maintenance in March 2010 for approximately six months. These two reactors have produced the entire U.S. isotope supply.

The Department of Energy, National Nuclear Security Administration, Office of European and African Threat Reduction, Global Threat Reduction Initiative, has launched an effort to redevelop domestic production of medical and research isotopes. This initiative is supported by legislation introduced by Rep. Edward J. Markey (D-Mass.) and Rep. Fred Upton (R-Mich.) The American Medical Isotopes Production Act (HR 3276) will provide the Department of Energy new authorities and resources to assist the private sector in establishing, as rapidly as possible, a robust domestic medical isotope production capacity. ASTRO staff remain engaged with the Department of Health and Human Services (HHS) Office of Global Health Affairs, which is the point of contact for collecting data on shortages and developing strategies to mitigate the impact on the health community. Members whose patients and/or practices are impacted by the radioisotope shortage are asked to report what they are experiencing and how they are dealing with the supply issue to Richard Martin at richardm@astro.org.

NIH’s new director outlines priorities at town hall meeting
On September 9, 2009, Francis Collins, M.D., Ph.D., director of the National Institutes of Health (NIH), hosted the first ever NIH town hall meeting with constituents, including representatives from approximately 250 different organizations. Dr. Collins said that he intends to push the innovation agenda and that he is supportive of reviewing and updating the peer review process used at NIH. He identified five areas of opportunity: discovery of fundamental biology (noting cancer as a major area for investigation); translational; science to work for benefit of healthcare reform (noting comparative effectiveness research and healthcare economics as examples); global health; and reinvigorating the biomedical research community.

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