On January 29, the House Committee on Energy and Commerce's subcommittee on oversight and investigations conducted a hearing focused on the adequacy of FDA efforts to protect the American public from excessive risks related to prescription drugs, medical devices, and other matters.
During the course of the hearing, subcommittee members heard from FDA Commissioner Andrew C. von Eschenbach, MD, as well as representatives from industry, academia, and the U.S. Government Accountability Office. Witnesses included Gail H. Cassell, PhD, vice president of scientific affairs for Eli Lilly and Co.; Catherine E. Woteki, PhD, global director of scientific affairs for Mars Inc.; and Dale Nordenberg, MD, managing director of healthcare industry advisory at PriceWaterhouseCoopers.
The subcommittee's hearing also considered the findings of a recent report from FDA's science board, FDA Science and Mission at Risk. Released last autumn, the report concluded that FDA is no longer able to fulfill its mission because its scientific base has eroded, its scientific workforce does not have sufficient capacity and capability, and its information technology infrastructure is inadequate. The report attributed the deficiencies to soaring demands on FDA and the fact that the agency's resources have not increased in proportion to those demands.
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AdvaMed's Ubl: FDA requires resources, careful review. |
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"AdvaMed has long advocated that FDA must be given adequate resources to continue its vital work of protecting and promoting the public health," Ubl continued. "To that end, AdvaMed has joined with patient groups, consumer advocates, public health organizations, and innovative companies to form the Alliance for a Stronger FDA. The alliance is committed to working proactively with the administration and Congress to ensure that FDA has the resources it needs to meet its public health mandate."
The Alliance for a Stronger FDA emerged earlier this month as the result of a merger between the Coalition for a Stronger FDA and the FDA Alliance. Both organizations, which began as independent entities in 2006, were founded to support the allocation of funding and resources necessary for FDA to fulfill its mission of protecting the public health. In addition to AdvaMed, the Medical Device Manufacturers Association (Washington, DC) is a member of the merged organization. (More background on the merger of Coalition for a Stronger FDA and the FDA Alliance can be found at http://devicelink.com/mx/issuesupdate/07/12/FDAAlliance.html.)
Although AdvaMed supports proposals to increase FDA resources, said Ubl, the organization is also encouraging FDA to review its activities and make sure it is focusing its time and resources on the areas likely to have the most significant impact on improving patient care. "Conversely, FDA should determine which of its activities have little or no impact on its mission and could be scaled back without adversely affecting the public health and safety," he added. "We are committed to working with FDA to identify ways the agency can use its available resources as effectively and efficiently as possible."
"Finally, given its limited resources, FDA should promote improvements to programs—such as those that were included in the FDA Amendments Act of 2007—that rely on FDA trained and accredited outside third parties to perform specific agency functions," Ubl said. "This is a way for FDA to further concentrate its expertise on areas that have the greatest benefit to patients, without in any way diminishing the agency's ability to inspect any facility, at any time, for any reason."
For more information about the Alliance for a Stronger FDA and the recent FDA science board report, look for a commentary by the alliance in the January/February 2008 issue of MX magazine (www.devicelink.com/mx). The commentary is part of the article "2008 Medtech Public Policy Watch," in which 10 leading industry organizations outline their policy agendas for the coming year.
© 2008 Canon Communications LLC
