FDA Studies Criticized by Editors of Leading Medical Journals (written by Lauren Uzdienski @ HealthPointCapital)
Ahead of yesterday’s House hearing, entitled Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs, Democrats asked the editors of leading medical journals to review two studies suggesting that the FDA is impeding U.S. device innovation. Their responses were scathing.
Last November, Josh Makower published the results of a survey suggesting that the U.S. regulatory system was “unpredictable and characterized by disruptions and delays,” echoing the concerns that many device manufacturers have expressed over the past several years. A similar study was published by the California Healthcare Institute earlier this year.
The House Subcommittee on Oversight and Investigations assembled a panel consisting of editors from the New England Journal of Medicine, the Archives of Internal Medicine and the Journal of the American Medical Association to assess whether these studies could be used to “form an appropriate basis for policymaking.” The panelconcluded that these studies would not survive peer review at a major journal, citing low response rates, design flaws and conflicts of interest as potential concerns.
Few media reports have surfaced following yesterday’s hearing, though background documents indicate that among the topics were increasing FDA review times, consistency in review and data requirements and patient access to innovative products. The FDA today addressed one of those issues – increasing submission review times – by blaming industry. They said that 83% of initial submissions and 82% of the follow-up submissions have “at least one deficiency related to quality.”