Regulatory Focus™ > News Articles > US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

Posted 08 October 2015 | By Zachary Brennan 

US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama.


Six staff scientists, former employees of CDRH's Office of Device Evaluation (ODE), first brought their concerns about the safety of some medical devices to FDA in 2007, and later to the Inspector General of the US Department of Health and Human Services (HHS), the White House and Congress.

In 2012, OSC began investigating the case of the whistleblower comments. An OSC spokesman clarified to RAPS that this letter to Obama means that the case is technically closed.

Colonography Allegations

The unidentified whistleblower at FDA specifically alleged that a computerized tomography (CT) image analysis software package manufactured by General Electric Healthcare (GE), had a new intended use compared to its predicate device and should not have been approved via a 510(k) application.

According to the whistleblower, when a new intended use for a device is identified in comparison to a predicate device, FDA reviewers should assess the device using the more stringent premarket approval (PMA) process. The whistleblower alleged that because the PMA process was not used, several devices were improperly approved for use as screening tools on asymptomatic patients, and a large segment of the population could be exposed to unnecessary CT scans, with the potential to cause cancer.

The whistleblower also explained that FDA has never cleared or approved a CT scanner for use in screening of asymptomatic patients of any age.

The whistleblower further alleged that there is insufficient data showing that the use of CT technology for population screening outweighs the risks. And for asymptomatic patients, regular and/or repeated CT screening of the colon is unlikely to identify a serious disease, and the potential harm to the patient may outweigh the presumed benefit, the whistleblower claimed.

Mammography Allegations

In addition to the CT software from GE, the whistleblower also alleged that FDA managers ignored review team concerns that Carestream failed to provide adequate analytical data in support of its PMA application for a digital mammography device intended to screen and diagnose breast cancer. FDA managers, according to the whistleblower, circumvented FDA's procedures and approved Carestream's application despite concerns the review team raised that the manufacturer failed to "empirically refute a trend questioning the effectiveness of the device in detecting cancers that appear as microcalcifications in the breast."

FDA Commissioner Report

The FDA commissioner's report explained first that the review of the GE 510(K) application revealed that a prior Viatronix device was cleared for asymptomatic screening and was appropriately cited by GE as a predicate device to its own device.

The commissioner's 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 asymptomatic patients, arguing that the Viatronix device was not cleared for such a purpose. The commissioner's report noted that FDA reviewed whether the switch to asymptomatic screening constituted a new intended use, but concluded that the original Viatronix device was an appropriate predicate for asymptomatic screening, and the approval did not need to be rescinded.

As far as the Carestream allegations, the FDA commissioner, according to the OSC letter, also reviewed those but determined that the data relied upon by the whistleblower as evidence that the Carestream device was less able to detect malignant calcifications than screen-film was "highly subjective" and "of no clear clinical significance."

With respect to the whistleblower's allegations of procedural violations while reviewing the Carestream device, the commissioner found that the deputy director's decision to seek input from outside experts in mammography did not violate or appear to violate any law, rule or regulation.

The Office of the Inspector General (OIG) of HHS also released a separate report, finding that some FDA and company materials were missing from the approval files, though OIG made no determination as to whether the devices were appropriately approved.

OSC Report

Special Counsel Carolyn Lerner reports in her letter to Obama released late Wednesday that she's "determined that the reports meet all statutory requirements and that the findings of the agency head appear reasonable.

"The agency report and supplemental report did not substantiate the whistleblower's allegation that FDA employees acted improperly in approving several different types of colonography devices for use in general population screening or in approving the use of a Carestream digital mammography device for screening and diagnosing breast cancer," she wrote.

She also points to a new CDRH standard operating procedure (SOP) that will govern the compilation of the administrative file to ensure adequate documentation of the facts, data, science and deliberative process concerning premarket decisions. A second CDRH SOP addresses internal differences of professional opinion and dictates an approach for documenting associated scientific, clinical and regulatory findings, perspectives and opinions.

"Based on my review of the original disclosure and the agency's report and supplemental report, I have determined that the reports contain all of the information required by statute and that the findings appear to be reasonable," Lerner concluded.

Letter to President Obama

Congressional Report on the Whistleblower


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