Industry Opposes Idea Of New FDA Inspection Authority, Fee At House Hearing
This article was originally published in The Gray Sheet
Executive Summary
Several device industry representatives told lawmakers on Capitol Hill May 14 that additional FDA user fees and expansion of pre-approval inspection authority to include less risky, Class II devices should not be part of a proposed bill making its way through Congress. They got support from the Republican members of the panel
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FDA Globalization Act of 2009 is introduced in the House by Reps. John Dingell, D-Mich., Bart Stupak, D-Mich., and Frank Pallone, D-N.J., of the Energy and Commerce Committee. The bill calls for annual registration of foreign device manufacturing plants exporting products to the U.S., as well as payment of related fees (to be set by HHS for fiscal years 2010 through 2014). Other provisions are similar to those of last year's FDA Globalization Act proposal, but the current bill does not address frequency of device facility inspections, according to committee staff (1"The Gray Sheet" May 19, 2008, p. 4). The bill raises civil money penalties to $100,000 for an initial violation of requirements, and to $200,000 for subsequent violations. The bill also creates a dedicated foreign inspectorate to strengthen FDA monitoring of foreign facilities producing devices, drugs, foods and cosmetics, and prohibits FDA from closing any of its field laboratories. AdvaMed says it supports legislation to ensure the safety of medical devices exported into the U.S., but is still reviewing the specifics of the bill. Foreign inspections were among areas found lacking in a recent GAO report urging enhanced FDA oversight of medical products (2"The Gray Sheet" Jan. 26, 2009, p. 3). Pallone, who chairs the committee's Subcommittee on Health, says he plans hearings "in the coming weeks" to examine FDA inadequacies, "starting with medical devices.
FDA Globalization Act calls for foreign plant registration fees
FDA Globalization Act of 2009 is introduced in the House by Reps. John Dingell, D-Mich., Bart Stupak, D-Mich., and Frank Pallone, D-N.J., of the Energy and Commerce Committee. The bill calls for annual registration of foreign device manufacturing plants exporting products to the U.S., as well as payment of related fees (to be set by HHS for fiscal years 2010 through 2014). Other provisions are similar to those of last year's FDA Globalization Act proposal, but the current bill does not address frequency of device facility inspections, according to committee staff (1"The Gray Sheet" May 19, 2008, p. 4). The bill raises civil money penalties to $100,000 for an initial violation of requirements, and to $200,000 for subsequent violations. The bill also creates a dedicated foreign inspectorate to strengthen FDA monitoring of foreign facilities producing devices, drugs, foods and cosmetics, and prohibits FDA from closing any of its field laboratories. AdvaMed says it supports legislation to ensure the safety of medical devices exported into the U.S., but is still reviewing the specifics of the bill. Foreign inspections were among areas found lacking in a recent GAO report urging enhanced FDA oversight of medical products (2"The Gray Sheet" Jan. 26, 2009, p. 3). Pallone, who chairs the committee's Subcommittee on Health, says he plans hearings "in the coming weeks" to examine FDA inadequacies, "starting with medical devices.
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