FDA/CMS Data Sharing Encouraged In Senate Appropriations Report
Senate appropriators are pushing for more interaction between FDA and the Centers for Medicare and Medicaid Services during medical product reviews.
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FDA should spend $19 million of an increase in non-user fee funding in fiscal 2012 on the agency’s medical countermeasures effort, the Senate Appropriations Committee recommends in the report that accompanies the Agriculture/FDA appropriations bill approved by the panel Sept 8.
During the health care reform debate, much concern was expressed that results of comparative effectiveness research from the Patient-Centered Outcomes Research Institute could play a key role in Medicare coverage decisions. But CER has already been considered in making Medicare coverage decisions for years, recent Avalere Health analysis of national coverage determinations issued by CMS points out.
A June 23 memorandum of understanding on data sharing could serve as a first step toward parallel reviews by FDA and CMS for marketing approval and Medicare coverage, according to FDA