As noted above, the Heart Rhythm Society recommends that Congress recognize the importance of post-market surveillance, analysis, and reporting of ICDs and pacemakers in ensuring patient safety. However, the Food & Drug Administration (FDA) does not currently have the resources to make the necessary enhancements to the surveillance systems.
Funding for the FDA has not kept pace with inflation, while the agency’s responsibilities have expanded. In order to ensure that Congress makes the required commitment to ensure timely access to safe medical devices and restore public confidence in the agency, the Society has joined forces with more than 180 members to form the Alliance for a Stronger FDA, which is comprised of patient groups, nonprofit organizations, consumer advocates, public health organizations and companies from the food, pharmaceutical and medical devices sector, as well as three former Secretaries of the U.S. Department of Health and Human Services and six former FDA commissioners.
2011
Medical Device Patient Safety Act Introduced in the Senate (12/15/2011) — On Thursday, December 15, 2011, U.S. Senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation that would enhance the Food and Drug Administration oversight of medical device recalls, as well as the post-market surveillance and data collection tools. Learn more »
2009
House of Representatives Passes FY09 Appropriation (03/04/2009) — The U.S. House of Representatives passed the Fiscal Year (FY) 2009 appropriation on a vote of 245 to 178. This omnibus legislation (HR 1105) includes FY09 funding for nine appropriation bills, including Agriculture, Rural Development, FDA and Labor–Health and Human Services (HHS)–Education, not enacted last year because of disagreement between Democrats and President George W. Bush over spending levels. All health-related provisions increased over FY08. Learn more »
2008
The Alliance for a Stronger FDA recommends $2.25 billion for FY 2010 FDA Appropriation (12/03/2008) — The Alliance for a Stronger FDA sent a letter on November 24 to President-Elect Obama's transition team recommending the amount of $2.25 billion for the FY 2010 funding to ensure that the Agency has the resources it needs to fulfill its mission. Learn more »
The Society Continues Congressional Visits to Ensure Resources for Device Safety (02/2008) — As part of the Alliance for a Stronger FDA, the Heart Rhythm Society met with the offices of Representative Jo Ann Emerson (R-MO), member of the Appropriations Committee and Senator Sam Brownback (R-KS), ranking member of the Subcommittee on Financial Services and General Government to talk about the funding of FDA. Learn more »
