Special Counsel Clears FDA of Wrongs In Device-Related Whistleblower Case
The U.S. Office of Special Counsel has cleared the FDA after a whistleblower alleged the agency improperly approved colonography devices and a screening tool for breast cancer.
In a letter to President Barack Obama, Special Counsel Carol Lerner says the FDA’s investigations into whether the colonography device and a Carestream digital mammography tool appeared to be reasonable. The FDA commissioner, along with the Office of Inspector General for the HHS, had detailed their findings in reports.
Specifically, the whistleblower alleged that during the review of a premarket notification for a computerized tomography image analysis software package made by GE Healthcare, FDA reviewers determined the product had a new intended use. As a result, they should have used the more stringent PMA review process for the software, which is used in colonography procedures.
Because the PMA process wasn’t used, several devices were improperly approved as a screening tool for asymptomatic patients, exposing them to unnecessary, potentially cancer-causing CT scans, the whistleblower claimed.
The whistleblower also said the FDA has never cleared or approved a CT scanner for use in screening asymptomatic patients. In instructions for a similar device manufactured by Viatronix, the phrase “patient screening” is used, but refers only to screening and diagnosis of symptomatic patients. GE’s reliance on PMA-approved Viatronix device for asymptomatic patients to support its 510(k) “was misplaced,” the whistleblower alleged.
An FDA report acknowledged that during the review of the GE device, two of the reviewers raised concerns about the safety of using the devices for screening of asymptomatic patients, arguing that the Viatronix device was not cleared for such a purpose, according to Lerner’s letter. However, after examining the reviewer’s actions, the agency concluded the original Viatronix device was an appropriate predicate for asymptomatic screening, letting the approval stand.
The whistleblower also accused the FDA of not heeding reviewers’ concerns that Carestream didn’t include proper data to support its PMA for a digital mammography device. FDA managers allegedly failed to follow the review and approval procedures and approved the application, despite concerns about the device’s effectiveness in detecting cancers that appear as microcalcifications in the breast.
Several documents related to the PMA also were missing or unsigned. The FDA commissioner’s report concluded the errors were minor and didn’t compromise the legal or scientific basis for PMA approval.
The whistleblower concerns have made the FDA realize that more transparency in the premarket review process is needed, Lerner says.