FDA Scientists Say FDA is “Fundamentally [More] Broken”

Just this last week we posted that a group of nine FDA scientists from the Center for Devices and Radiological Health-- which is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery—authored a letter which asserted that “The FDA is "fundamentally broken" and requires reforms.”

We wrote:

With what A.P refers to as an “unusually blunt letter,” the group of federal scientists contacted "John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers," according to Kaiser.

In that post, we also called attention to the contention of the scientists that “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts.”

Noting that

To say that these managers had “incompatible” and “discordant” scientific and clinical expertise in devices is one thing. One expects a certain degree of disagreement within the scientific community—and to some extent, one reasonably relies upon the crucible of such “discordant” viewpoints in scientific debate to provide tested answers to real problems. But the scientists who wrote this letter added one more word: “irrelevant.” And in this context, that leaves us uncomfortably with the knowledge that in the estimation of these nine scientists, the determining force in these particular scientific inquiries—the managers—lack relevant scientific expertise in the pertinent subject matter—medical devices.

Apparently, the “expertise” at issue in the approval of a breast cancer imaging device is alleged to go somewhat beyond the scientific.

The New York Times reports that it has obtained various FDA emails and internal documents which underlie the scientists’ complaint and are the present subject of both an FDA internal inquiry and a congressional investigation. The emails and documents are said to provide details of the investigations which had not previously been made public.

The New York Times reports that

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 congressman is Republican Chris Shay, who lost re-election in November. A component of the imaging device was produced by a Fujifilm Medical Systems, which “is based in Stamford, Conn., the heart of Mr. Shays’s former district,” according to the NY Times.

The article also states that

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.

Read more here.