Sec. 5. Sense of Congress on the development and oversight of innovative treatment options for functional gastrointestinal and motility disorders
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It is the sense of Congress that, considering the current lack of effective treatment options for the global symptoms of functional gastrointestinal and motility disorders (in this section referred to as FGIMDs ) and the inherent challenges of developing and bringing such treatments to market, the Commissioner of Food and Drugs should continue and accelerate important efforts to improve the development and oversight of treatment options for FGIMDs by— enhancing the commitment to emerging efforts like the Patient Reported Outcomes Consortium to expedite medical device and drug development, study appropriate balances between risk and patient benefit, and identify proper endpoints for conditions without clear, biological indicators; enhancing the commitment to broad efforts like the Critical Path Initiative focused on ensuring that scientific breakthroughs are quickly translated into safe and beneficial treatment options; and continuing collaboration with patient organizations that treat FGIMDs so that the patient perspective is considered when determining the need for innovative treatments.