US Elections 2020
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Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Medicare actuaries indicate the ‘most-favored nations’ plan could limit patients’ access to medicine, though CMS’ Verma says she has confidence manufacturers won’t let that happen. Loss of access, combined with expected legal challenges, may make Democrats wary of embracing the Trump team’s last-minute rule, despite general agreement on the underlying policy idea. A Part D reference pricing policy is still in the works, CMS said.
Pfizer and BioNTech have accumulated enough safety data to submit an emergency use authorization, and Pfizer CEO Bourla says at the Stat Summit that he is ‘comfortable’ US distribution of the vaccine will go well despite the unusually complicated government transition.
Rebate Rule May Be Finalized Soon, But Skepticism Lingers That Trump Can Make Lasting Changes On Rx Pricing
Trump administration could also finalize international reference pricing plan, which could be riskier to industry as it's an area where Democrats and Trump have more alignment, but this proposal may be easier for industry to overturn in court than that rebate rule. A finalized rebate rule is under review by the Office of Management and Budget, but it is unclear if the coming proposal will have any teeth given the limitations imposed by the President’s summer executive order.
Trump’s Big Bet On COVID-19 Vaccines May Have Shortchanged Therapeutics. Should Biden Rectify The Difference?
Incoming US President may be wise to up government investment in COVID-19 therapeutics, including both research and manufacturing, experts say. Additional government funding should target a larger variety of treatment types and prioritize better study designs.
Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.
Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.
A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry.
Most FDA and CMS rules would sunset after 10 years unless action is taken by the agency under a new HHS proposed rule designed to enforce retrospective regulation review. Some experts worry this could allow an administration to skirt traditional notice and comment periods before rule rescissions. The implementation of the rule would likely look very different at FDA than at CMS, experts added.
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.
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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