The Center for Devices and Radiological Health (CDRH) director, Dr. Jeffrey Shuren, has strongly refuted findings from a recent study, according to which, over three-quarters of the cost to bring a medical device from concept to the US market is spent on clearing regulatory obstacles, it has been reported. He was speaking at the annual FDA update at the Massachusetts Medical Society sponsored by Massachusetts Medical Device Industry Council in association with the American Society for Quality, New England Biomedical Discussion Group and the Regulatory Affairs Professional Society - Boston Chapter.
According to Shuren, the study, conducted by researchers at the Stanford University, was 'highly flawed'. The study titled 'FDA Impact on U.S. Medical Technology Innovation', reported that regulatory processes and inefficiencies at the FDA delay patient access to treatment, and increase costs. The report, according to its authors, was based on a survey of over 200 small and medium sized medical technology companies in the US to examine the impact FDA regulatory processes have on innovation, patient care and job-creation.
In his response, Dr. Josh Makower, one of the authors of the study, has said that the report's premise on costs were correct. This is because US regulators influence the process much earlier than their European counterparts, due to a lack of uniformity in the investigational device exemption process. According to Dr. Makower, costs for the medical device manufacturer rise as they try to build clinical studies and find endpoints that US regulators will agree to. Further, he added that FDA officials had seen the results of the study prior to being publicly released. He hoped that the findings would help create collaboration and not acrimony.
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