Dems slam FDA critics ahead of medical device hearing


"All three independent reviewers and the Food and Drug Administration identified major problems with both studies, raising significant questions about their methodologies and their appropriateness for serving as the basis of new policies governing the medical device approval process," the Democratic memo said. Criticism includes low response rates, design flaws and "apples to oranges" comparisons between the American and European regimes.

"Although the report refers to this work as a 'study,' it is not really a study at all," wrote New England Journal of Medicine executive editor Gregory Curfman. "This is an opinion piece that is dressed up to look like a research study. In fact, there are so many flaws in design and execution that the authors' conclusions are rendered essentially meaningless."

Democrats on the panel touted the memo at the hearing.

"The journal editors concluded that the studies would not be fit for publication in a peer- reviewed journal," ranking member Rep. Diana DeGette (D-Col.) said in her opening statements. "As we consider the role of the FDA, we must rely on the facts. The expert analysis of these two studies shows the pitfalls of relying on one-sided analyses of problems in the device industry."