Dems slam FDA critics ahead of medical device hearing

House Energy and Commerce Committee Democrats sought to blunt Republican attacks on medical device regulations Wednesday by asking medical journal editors to weigh in.

Democrats point out that much of the criticism against the Food and Drug Administration's regulation of medical devices has relied on two studies that were funded by the industry and weren't published in a peer-reviewed journal. The studies argue that medical device approval is slower and more convoluted in the U.S. than in Europe.

Democrats asked the editors of three respected journals — The New England Journal of Medicine, the Archives of Internal Medicine and the Journal of the American Medical Association — to review the two studies ahead of Wednesday's hearing by the E&C oversight panel. The goal, Democrats said in a memo summarizing the editors' conclusions, was to "determine whether these studies form an appropriate basis for policymaking."

"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."

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