“Lame Duck” Congress Has High Stakes For Pharma Companies
Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph reform could have ripple effects on the plans to modernize the US FDA Office of New Drugs.
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Democrat-Controlled House Will Turn Up The Volume On Drug Pricing
With US House of Representatives now controlled by Democrats, lower chamber of Congress will likely increase hearings and investigations into industry pricing practices, but any legislation will likely need to dovetail with President Trump’s agenda to advance.
Biodefense Bill Moving In Senate; Still Debate Over Best Approach For Flu
US Pandemic and All Hazards Preparedness Act appears on track for on-time reauthorization – but there may still be debate over whether and how to dedicate funding specifically for pandemic flu preparedness and stockpiling.
Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions
Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).