OFFICIALS LEGISLATION INTEREST GROUPS PUBLIC STATEMENTS COMMITTEES VETOES

FDA and Cardiac Device Recalls

Date: Sept. 14, 2005
Location: Washington, DC
Issues: Health and Health Care


FDA and Cardiac Device Recalls

Sen. Chuck Grassley, Chairman of the Committee on Finance, issued the following comment today related to the recall of cardiac devices by the Food and Drug Administration. On August 18, the FDA provided Finance Committee staff with a briefing requested by the Chairman. During the briefing, Committee staff requested additional documents from the FDA.

Sen. Grassley said, "Senior FDA officials acknowledged to my staff that CDRH needed to do a better job. When a regulatory agency official says ‘there's a lot of stuff going on under the table,' how can Americans rest easy?"

Sen. Grassley has conducted oversight of the Food and Drug Administration over the last 18 months and called for administrative and legislative changes to make the agency more responsive to new information about safety risks with drugs and devices. Two separate letters from Sen. Grassley to the FDA related to cardiac devices were previously posted on the
Committee's website.

http://finance.senate.gov/press/Gpress/2005/prg091505.pdf

arrow_upward