DeLauro Tells FDA: Close the Gap on Medical Device Reporting
FOR IMMEDIATE RELEASE
Monday, September 12, 2005
DeLauro Tells FDA: Close the Gap on Medical Device Reporting
- Trade Secrets, Funding Do Not Trump Public Health Concerns -
WASHINGTON, D.C. - Congresswoman Rosa L. DeLauro (Conn.-3) today called on the Food and Drug Administration (FDA) to close the gap on reporting potential problems with medical devices. DeLauro's warning comes on the heels of a media report today, which revealed that FDA was warned of problems with Guidant Corporation heart devices months before the agency issued a safety alert. In March, a college student from Minnesota died as a result of a faulty device. DeLauro is ranking member of the House Appropriations Agriculture Subcommittee, which has jurisdiction over the FDA budget.
"Doctors and patients rely on safety information from the FDA for the medical devices they use. It is disappointing to see that after this agency claimed they would offer more transparency with information on drug trials, the public is suffering because of gaps in reporting the dangers of medical devices. An Institute of Medicine report released in July found that the Center for Devices and Radiological Health (CDRH) failed to perform effective monitoring of the safety of medical devices. After a string of disturbing recalls of critical devices, why isn't CDRH more on top of it by now?
"I am particularly troubled by quotes from the director CDRH that the agency would 'tie up too many resources to review hundreds of filings the FDA receives each year' from heart device makers on potential problems. When asked for this information previously, the agency claimed trade secrets prevented this disclosure.
"When public health is at stake, trade secrets and funding do not trump the FDA's critical responsibilities. If this agency finds it cannot get basic responsibilities done with existing resources, they have an obligation to notify Congress. I urge this agency to immediately close the gap on reporting problems with medical devices. I have previously expressed concern over this problem and will be closely monitoring how FDA addresses it."
http://www.house.gov/delauro/press/2005/September/med_devices_09_12_05.html