President ????: What US Election Uncertainty Means For Biopharma
Worst case scenario is civil unrest that might disrupt clinical trials and manufacturing. Under a more moderate scenario, companies must delay business planning because the US policy environment remains cloudy.
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Regardless of the outcomes of the US elections, drug pricing is likely to take a back seat to COVID as policy focus. But the pandemic does offer pharma an opportunity for partnerships with payers on health outcomes. Commonwealth Fund’s Liz Fowler, South Capitol’s John O’Brien and ICER’s Steve Pearson discuss where drug pricing stands in public opinion, whether policies embraced by President Trump will have staying power, and the conditions needed in the policy environment for major change.
Under test payment model, Medicare would pay no more than most-favored-nation price for Part B and Part D drugs, but how and when the model program would be implemented remains unclear. BIO may pursue legal action as questions on how plan would be implemented and if the administration will provide notice and comment period for stakeholder input remain.
Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA
US FDA Commissioner Hahn’s credibility is in question following an emergency use authorization for convalescent plasma, leading some former officials to push for new agency leadership. Hahn’s actions, combined with President Trump’s attack on FDA staff as being ‘deep state’ actors, may compromise the public trust in the agency’s work during COVID-19 and beyond, former FDA officials say.