by
Astrid Fiano, DOTmed News Writer | May 05, 2008
Food and Drug
Administration
Senate legislators are targeting improvements for the Food and Drug Administration. A bipartisan group has recommended that the FDA receive more funding after listening to testimony during a Senate Appropriations subcommittee hearing this month. Sen. Herb Kohl (D-WI) said the agency was "seriously underfunded," according to a recent New York Times article. In testimony to the subcommittee, FDA Commissioner Andrew C. von Eschenbach, M.D., discussed the agency's budget request and the stressed the need to modernize the FDA's workforce and infrastructure.
In the House, Energy and Commerce Committee Chair John Dingell (D-Mich.) has new legislation proposed for increased FDA funds and regulatory changes. During a Senate subcommittee on health for the Committee on Oversight and Commerce hearing last week, Rep. Dingell told the committee members that the FDA is "starved" for resources. Rep. Dingell's proposals are in The Discussion Draft Food and Drug Administration Globalization Act. The Act builds upon previous House bills and results from subcommittee investigations, and has changes to current FDA law including: an annual registration fee for domestic and foreign drug and device establishments; a requirement for domestic and foreign drug and device establishments to be inspected every 2 years; giving the Secretary of Health and Human Services the same recall authority with respect to drugs as the Secretary has with respect to devices; and a requirement for importers of food, drugs, devices, and cosmetics to register with the Secretary and to pay an annual registration fee of $10,000.
The FDA itself has previously stressed to Congress this year that it needs considerably more funding. Janet Woodcock, deputy commissioner for scientific affairs and chief medical officer, testified in February to the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies concerning budgetary needs for import investigations and better prescription drug-tracking. Shortly thereafter, in light of concerns over the Heparin problems, Congresswoman Rosa L. DeLauro (D-CT) called for a larger FDA budget of $145 million over 2007 funding, but also for less influence on the agency from drug companies and better management.

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More information:
http://appropriations.senate.gov/hearings.cfm?s=arg
http://www.house.gov/delauro/
https://www.dotmed.com/news/story/5424/