July 18,2005

Chairman Grassley asks FDA about disclosure of risk information for medical devices including pacemakers and defibrillators

July 18, 2005

VIA FACSIMILE: (301) 827-1960

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Crawford:

The Committee on Finance (Committee) has jurisdiction over the Medicare andMedicaid programs, among other matters. Accordingly, the Committee is responsible tothe more than 80 million Americans who receive health care coverage under thoseprograms, including payment for medical devices.Today, Guidant Corporation (Guidant) issued a press release entitled, “GuidantInitiates Worldwide Physician Communications Regarding Important Safety Informationand Corrective Action about Certain Pacemakers.” Guidant’s action today, which thecompany says the Food and Drug Administration (FDA) may classify as a recall, comeson the heels of recalls for several other Guidant devices, specifically Implantable CardiacDefibrillators.

As Chairman of the Committee, I request that the FDA provide the Committeewith copies of the past five annual postapproval reports—required under 21 C.F.R.814.84—for all pacemakers and defibrillators associated with Guidant’s device warnings,issued on May 25, June 17, June 24 and July 18, 2005. In addition, it is myunderstanding that the FDA does not presently make all device manufacturers’ annualpostapproval reports publicly available, despite the fact that the reports contain importantperformance data. Among other detailed information, pacemaker and defibrillatormanufacturers must report to the FDA the number of patient deaths, analyses of failuremechanisms, and other safety and effectiveness issues. Given the importance of suchinformation to health care providers and the scientific community, state why the FDAshould not proactively post such information in the FDA’s electronic reading room. Inaddition, describe in detail the FDA’s disclosure policy with respect to post approvalrelateddocuments for devices, including but not limited to pacemakers and defibrillators.

Thank you in advance for having your staff coordinate with my staff about thisletter by July 22, 2005. I would appreciate your response by August 3, 2005, unless it isavailable sooner. Any questions or concerns should be directed to Dan Donovan, SeniorInvestigative Counsel, at (202) 224-4515, or dan_donovan@finance-rep.senate.gov. Allformal correspondence should be sent electronically in PDF searchable format tothomas_novelli@finance-rep.senate.gov or via facsimile to (202) 228-2131 and originalby U.S. mail. Please do not hesitate to contact me if you have any concerns.


Charles E. Grassley