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  • krp76 replied to the topic Changes in FDA under Trump's Administration in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago

    The user fees increase could be a benefit for the industry as it has the potential to increase the regulatory timeline for FDA. This can allow for drugs and medical devices to reach market quicker and aide thousands of patients in a more effective manner. There are also potential setbacks that can result from this move, as the increase in user fees still does guarantee a quicker regulatory timeline, the two are not necessarily correlated, in the sense that just because the FDA now has a larger war chest does not mean the regulatory timeline will suddenly increase, if the process flow is not improved and funds are not appropriated in the correct areas. Moreover, there can be a setback to the consumers as well, because these costs of increased user fees may get past down to the consumer eventually in the final product cost. So as to alexandrabuga’s point above I would agree that although the tax burden may be reduced the cost will eventually find it’s way towards the consumer. It should also be taken into account that this additional cost may be worth it if it is able to provide life saving devices and drugs to market with increased quality and efficiency, providing a better outcome for the patient.

    Sources
    http://www.raps.org/Regulatory-Focus/News/2017/08/21/28282/Regulatory-Explainer-FDA-User-Fee-Reauthorizations-From-2018-to-2022/