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Reduced NIH Funding, New Interoperability Language, Offsets in Latest Cures Legislation; House Prepares for Vote Next Week

Ahead of a scheduled floor vote next week, the House Rules Committee released an updated 21st Century Cures bill that adds offsets, many of which come from Medicare and Medicaid, and reduces the funding increase for the National Institutes of Health.

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As the House lawmakers push for FDA to step up use of biomarkers to streamline clinical trials, FDA announced it will hold a public meeting Oct. 16 to look at developing non-microbial biomarkers of infection for in vitro diagnostic devices.

House appropriators are demanding that FDA dramatically revise its compounding policies, suggesting in report language that the agency overreached its statutory authority by penning a memorandum of understanding that covers dispensing, and that the agency went against Congressional intent by prohibiting office-use compounding.

Republican Sen. Bill Cassidy (LA) recently suggested cuts to HIV/AIDS research in the 2016 HHS spending bill in order to better fund research for the diseases which are currently killing the most Americans.

Reps. Steve Stivers (R-OH) and Peter Welch (D-VT) reintroduced bipartisan legislation aimed at stopping brand drug makers from using restrictive safety designations, known as Risk Evaluation and Mitigation Strategies (REMS), to delay generic drug entry into the market.

The head of a biosimilar company says CMS is allowing interchangeability within its Part D formulary by not considering the reference and biosimilar products as different drugs to satisfy the two distinct drugs requirement for each categories and classes.

The Senate Appropriations Committee budget report states that the level of improper pay in the Medicare program indicates that more work needs to be done to avoid fraud, waste and abuse.

Under pressure from hospitals, CMS proposed Wednesday (July 1) to recognize some hospital stays shorter than two midnights as legitimate, but the agency says it believes it will still be rare for patients to be admitted for less than two-midnights.

Congress should not change the process that the Patent and Trademark Office uses to review patent challenges to drugs and biopharmaceuticals, professors at Duke Law and New York Law School tell Senate Judiciary Committee members.