- Posted March 7, 2014 by
Washington DC, District of Columbia
- FDA Issues Warning Letter to Edwards Lifesciences, for misbranding of Myxo ETlogix annuloplasty Ring
- Northwestern University 5pm ET Deadline Today to Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation
- Grassley not satisfied with the responses, continues to press the issue
- Medical Institutions Identified in Secret Testing in Senate Investigation FDA not Responding: Part I
- Part II: Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
Grassley Seeks Documents from Northwestern University on Heart Valve Device
"WASHINGTON – Sen. Chuck Grassley of Iowa is asking Northwestern University for documents on a medical device implanted in patients for heart valve repair. Grassley wrote to the university in 2008 and 2009 about the Myxo device over allegations that the device had not been cleared by the Food and Drug Administration (FDA) before it was implanted in patients as part of an outcomes study.
Since then, new allegations have come to light that Northwestern did not provide all of the documents to Grassley that were squarely within the scope of his request, and that Northwestern failed to provide any notice or explanation of why it was withholding certain documents. In a letter this week to the presidents of Northwestern University and Northwestern Memorial Hospital, Grassley asks for the documents apparently withheld from him in response to his earlier inquiries.
The documents are important to reviewing whether Northwestern’s use of the devices was appropriate and whether notification to patients was adequate.
Grassley has a longstanding interest in FDA oversight and patient safety."
The text of his letter is available here: