US Election 2016
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CDER Director's' video advises focusing on the work and "keeping our heads down."
Latest From Elections & BioPharmaceutical
As national elections loom, India’s prime minister has said the government will expand a retail scheme to sell cut-price no-name generic drugs intended to make medicines more affordable for the poor, and some analysts are expecting a potentially significant commercial impact on the country's main branded generics sector.
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.
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 probably need to dovetail with President Trump’s agenda to advance.
President Trump is empty-handed on health care victories so far, as initial health reform repeal efforts collapsed and the shock value of drug pricing tweets wore off. But some actions may evolve into biopharma impact further down the road.
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