FDA Investigation Could Restrict Use Of Pediatric Coronary Stents

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Pediatric Coronary Stents

The Wall Street Journal on Thursday examined the criminal investigation of the pediatric device company NuMedand its President and CEO Allen Tower. NuMed manufactures custom-madecatheters, therapeutic balloons and stents for children. Tower is beinginvestigated by FDAand federal prosecutors in Delaware on possible charges that hemarketed unapproved stents for use in children, which could result in amultimillion dollar fine and limits on his ability to sell the devices.

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FDA found that Tower delivered more than 30 stents to two doctors at the DuPont Hospital for Childrenin Wilmington, Del., and concluded that the hospital was using thedevices too often for them to be considered "custom devices," approvedfor use in emergencies. FDA told Tower he needed to file with theagency for specific approval each time he sold a device, which Toweradmits he might not have done.

According to the Journal,the case against Tower "offers a window into a crucial dilemmainvolving pediatric heart devices." While FDA is not questioning thesafety of NuMed's devices, physicians worry that the pediatric devices"could become even harder to get" if Tower is prosecuted successfully,the Journal reports. Physicians say that treating infantsand children with devices that are approved for use in adults is lesssafe than using the unapproved devices manufactured by NuMed and thatwithout companies such as NuMed, children will need to go to Europe toreceive pediatric cardiac devices. The devices are approved in Europefor emergency uses.

More than 580 cardiologists and parentsfrom around the world have signed a petition that says any actionagainst NuMed could result in "a devastating loss to patients ...should Mr. Tower be relieved of his freedom or ability to continue hiswork." Larry Latson, director of the congenital cardiac catheterizationlab at the Cleveland Clinic,said, "The FDA wants more data" to approve pediatric devices "yet thereare few patients to acquire the data," adding, "FDA's system does notwork well for fields like ours, where there are small numbers of widelyvarying patients" (Burton/Banjo, Wall Street Journal, 7/5).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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