An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.
The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.
The larger issue is this:
Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zucker, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”
The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.
A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.