Watchdog Rejects Allegation Of Improper FDA Approval For Cancer Screening Devices
The Office of Special Counsel says the complaints were not substantiated. In other Food & Drug Administration news, Dr. Robert Califf, the Duke cardiologist nominated to lead the agency, asked to have his name removed from a series of papers examining clinical trials that he co-wrote. The unusual move raised questions and potential ethical concerns.
The Wall Street Journal:
Watchdog Agency Rejects Whistleblower Claims On FDA Medical Device Approvals
A government watchdog agency rejected a high-profile whistleblower’s claims that the Food and Drug Administration improperly approved medical imaging devices for breast-cancer and colon-cancer screening. In a report to President Barack Obama made public late Wednesday, the head of the U.S. Office of Special Counsel said the complaints weren't substantiated. Special Counsel Carolyn N. Lerner, whose agency evaluates whistleblower allegations within federal departments, concluded that the investigations by the FDA and its parent agency, the Department of Health and Human Services, “appear to be reasonable.” Those investigations turned up no agency wrongdoing. (Burton, 10/7)
Boston Globe's Stat News:
FDA Official Took Name Off Papers
President Obama’s nominee to lead the Food and Drug Administration recently coauthored a series of scientific papers raising concerns about the agency’s oversight of clinical trials but asked that his name be removed before publication, according to other authors. ... The heart of the series is an examination of what are known as pragmatic clinical trials — an increasingly popular type of study that seeks to compare two or more treatments in a real-world setting instead of in a traditional clinical environment. Portions of the papers are critical of the agency and recommend policy changes that would be highly divisive. (Kaplan, 10/7)