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PCAST Co-Chair Encourages Observation Of Antibiotic Therapeutic Use In WH Action Plan

A White House action plan to address antibiotic-resistant bacteria released Friday (March 27) relies on FDA’s guidance that has manufacturers voluntarily revise FDA-approved use conditions on labels of medically important antibiotics to remove production indications.

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Lobbyists for hospitals and drugs makers say they would not be surprised if lawmakers take up a 340B bill to monitor hospitals use the savings from the 340B drug discount program and to clarify which patients for whom hospitals may claim discounts.

A home health group is pushing the latest version of a bill that would bundle post-acute care payments and allow providers to split savings from coordinated care, though other post-acute care provider groups have raised concerns.

CMS insurance oversight chief Kevin Counihan said the agency will hold a symposium in May focusing on self-sustainability strategies for state-based marketplaces (SBMs).

Outgoing FDA Commissioner Margaret Hamburg warned against lowering regulatory standards to bring products to market more quickly in what is likely her final formal address before she steps down at the end of the month.

A bipartisan group of senators and House lawmakers are urging CMS to hold off on a new risk adjustment model they say doesn't properly compensate Medicare Advantage insurance companies for their sickest patients.

Trial lawyers and consumer advocates are hosting a meeting on Capitol Hill Thursday (March 26) to drum up support for a controversial FDA proposed rule that would force generic drug companies to update their labels independent of their brand counterparts.

Rep. Louise Slaughter (D-NY) reintroduced a bill to limit eight classes of antibiotics for treatment of humans and sick animals only and prevent them from being routinely fed to healthy animals, saying FDA's voluntary guidance is an “inadequate response to the overuse of antibiotics on the farm.”

Senate health committee Democrats said Tuesday (March 24) that if Republicans are serious about spurring medical innovation they would do away with the sequester, raise budget caps and devote more resources to tackling the problem, including boosting funds for the National Institutes of Health and FDA.