OSC supports FDA after investigating whistleblower’s claims

The U.S. Office of Special Counsel (OSC) has investigated and rejected a whistleblower’s claims that certain FDA employees repeatedly violated agency regulations when approving medical devices involved in cancer screenings.

The whistleblower alleged that the employees in question improperly approved both colonography devices used to screen for colon cancer and digital mammography devices used for screening breast cancer.

One example of the employees’ alleged misconduct, according to the whistleblower, was that a CT image analysis software package was discovered to have a new intended use and was not properly assessed. Because of this, the whistleblower told the OSC, “a large segment of the population could be exposed to unnecessary CT scans, with the potential to cause cancer.”

Another example of alleged misconduct involved a digital mammography device being approved despite numerous issues being raised by the review team about the device’s effectiveness.

In her report to President Obama, Special Counsel Carolyn Lerner wrote that the OSC did not find evidence that supported the allegations, but changes were still being made to improve the overall medical device approval process.

“As a result of the investigation, the agency took steps towards making the medical device premarket approval process more transparent, predictable, and consistent,” Lerner wrote “These efforts included more than 35 new initiatives designed to strengthen device review procedures and ensure the creation of a complete administrative file documenting the deliberative process concerning premarket decisions and the balance of device benefits versus risks. In addition, the agency adopted procedures to address internal differences of professional opinion, as well as for documenting associated scientific, clinical and regulatory findings, perspectives and opinions.”

The full 25-page report is available on the OSC’s website.