July 20,2005

Grassley questions FDA about safety and surveillance of medical devices based on new report in the New England Journal of Medicine

July 20, 2005

VIA FACSIMILE: (301) 827-1960

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

Dear Commissioner Crawford:

Today, the New England Journal of Medicine (NEJM), published an extremelytroubling article, entitled, “The Controversy over Guidant’s Implantable Defibrillators.”The article lays out the tragic details behind the death of a young college student, JoshuaOukrop, who died with a failed implantable cardioverter-defibrillator (ICD) in his chest.The ICD-a Ventak Prizm 2 DR Model 1861-was manufactured by Guidant Corporation(Guidant) and the failure was reportedly caused by a short circuit. I understand that boththe Food and Drug Administration (FDA) and Guidant are investigating Mr. Oukrop’sdeath presently.

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. According to the NEJM, “[i]n 2003,the Centers for Medicare and Medicaid Services paid for 52,500 ICD implantations; in2004, it paid for 65,000. With expanded coverage, more than 500,000 Medicarebeneficiaries may become eligible for an ICD.” As Chairman of the Committee, I amgreatly concerned about the public health, safety and regulatory issues associated withmedical devices in general and the specific details associated with the death of Mr.Oukrup.

Among other troubling matters, the NEJM reports that “[f]or more than threeyears, Guidant kept quiet about the serious malfunctions of some of its ICDs andcontinued to sell defective devices after it made the manufacturing changes to fix thedefect.” The NEJM also states that “[t]he fallout from the potentially preventable deathof Joshua Oukrop has triggered a broad discussion about the propriety of Guidant’sactions and the safety of ICDs and medical devices in general. It has also led to debateabout the appropriate standards for informing physicians and patients about safety issuesand the responsibilities of industry, the FDA, and the medical community.”

On July 18, 2005, I requested information from FDA related to the ICD involvedwith the death of Joshua Oukrop. I asked you why important device performanceinformation reported to the FDA by device manufacturers, and specifically forpacemakers and defibrillators, was not publicly available to patients, health careproviders and the scientific community. That same day the Institute of Medicinereleased a report entitled, Safe Medical Devices for Children. This report exposes afissure in the FDA’s safety mission when it comes to surveillance of medical devices forchildren. It documents how the FDA is neither properly monitoring postmarket studiesnor making important postmarket research publicly available. Dr. Crawford, these arethe same kinds of problems we’ve seen with the postmarket review of medicines, as wellas with medical devices used for adults. The Institute of Medicine spells out remediesthat should be pursued to better protect children who rely on FDA approved medicaldevices.

It is the shared responsibility of the medical device industry, the FDA, themedical community and Congress, to address the safety issues associated with medicaldevices. The NEJM reports that the Heart Rhythm Society, a professional association ofarrythmia specialists, plans to develop guidelines regarding ICD recalls, manufacturernotificationstandards, and when to replace devices. In addition, Guidant is apparentlyestablishing its own panel of experts to recommend guidelines for disseminatinginformation. Please state whether the FDA is reexamining its regulations and proceduresfor device surveillance. In addition, describe in detail what action the FDA will take, ifany, to address both the IOM’s report and the safety of ICDs and medical devices ingeneral. Finally, I request that the FDA provide my Committee staff with a detailedbriefing on the regulatory history of Guidant’s Ventak Prizm 2 DR Model 1861, as wellas a status report regarding all investigation(s) associated with the death of Mr. Oukrop,in addition to the information requested in my letter dated July 18, 2005.

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 8, 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 via facsimile to (202) 228-2131 and original byU.S. mail. Please do not hesitate to contact me if you have any concerns.


Charles E. Grassley