Congressman Raises Essure AER Questions

Rep. Michael Fitzpatrick (R-PA) says that he has information showing a “dramatic change in how adverse event reports relating to the permanent sterilization device Essure were submitted to FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.” In a 4/19 letter to CDRH director Jeffrey Shuren, Fitzpatrick says that from 1/2002 through 6/2015, Bayer submitted nearly 600 adverse event reports that coded the reporter as a doctor. But as of 7/2015 the coding changed dramatically, he writes. “After FDA’s public announcement [that it was reviewing the safety and effectiveness of the Essure device],” Fitzpatrick writes, “adverse event reports received by the agency from the manufacturer of Essure no longer coded reports from medical doctors as physician reports. Instead, almost every report received from a physician between 8/2015 and February listed the reporter occupation field as ‘other.’ … A similar change was noted in reports received from nurses.”

The letter asks the Center to review the adverse event reports from doctors and answer these questions:
        Did FDA ask Bayer to change how it coded doctor reports?         If FDA did not request the change, is there a legitimate reason for a company to suddenly change report coding in this way?         Was FDA aware of the change?         Did Bayer notify FDA that it was changing how it reported the occupation field in the adverse event reports?         Was FDA aware of this change before the 9/24/15 advisory committee meeting related to Essure?         Does FDA review adverse event reports coded as coming from doctors differently than reports coded as coming from “other?” Are doctor reports given more weight?         If FDA were to generate a list of adverse event reports received from physicians about Essure, would reports coded as “other” be included? If the reporter occupation is listed as “other,” does FDA conduct additional analysis of the narrative portion of the report to determine if it came from a medical doctor?         Is it illegal for a manufacturer to knowingly manipulate data listed on an adverse event report?         What are the penalties for knowingly submitting false information to FDA in an adverse event report?         Has FDA ever held a manufacturer accountable for falsifying or intentionally miscoding information submitted in an adverse event report?