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US Elections 2020

Set Alert for Elections

US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options

White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as FDA Commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.

FDA Politics

Trump’s Legacy Versus ‘March In’ Rights

Biden’s incoming Secretary of Health is a fan of ‘march in’ rights as a cost-containment tool for medicines. Two hold-overs from Trump Presidency may slow him down.

Elections Intellectual Property

Biden Regulatory Freeze May Pause Sunset Rule, Medicare Rebate, Medicaid Line Extension Regs

Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.

Elections Regulation

Making The Case For A Legislative Deal On Drug Pricing

Drawing on 24 years as a legislator and another 16 years as a leading lobbyist for biopharma, Jim Greenwood sees an opportunity for industry to put drug pricing behind us with a legislative compromise.

Pricing Debate Legislation

COVID-19 Vaccine Distribution Confusion Grows As Eligibility Widens

President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.

Distribution Coronavirus COVID-19

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

FDA Leadership

Not So Fast: Trump Team Paints US FDA Review Times As Too Slow

New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.

Drug Review FDA

Insulin Report Revives Senate Finance Committee Push On Drug Pricing Legislation

Report released as soon-to-be committee chair Ron Wyden, D-OR, assembles plans for drug pricing legislation in the new Democratic-controlled Senate.

Pricing Debate Legislation

Woodcock To Be Acting US FDA Commissioner, Leaving Agency in Stable, Capable Hands

Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.

FDA Leadership

Medicare Payment Model Experimentation Under Biden Administration ‘Pretty Wide Open’

Former CMS acting administrator Andy Slavitt says agency’s direction during Biden administration depends on nominee, but trust fund’s looming insolvency will be ‘an issue you can’t avoid.’ The president’s priorities around health equity, racial justice and mental health will make their way into CMS policy and demonstration models, Slavitt suggests.

Pricing Strategies Medicare

Rx Industry Reassessing Political Donations In Wake Of Riots; Shift Towards Democrats Already Underway

Donation patterns in 2020 campaign suggest rethinking may have taken place before the mob attacked the Capitol, potentially an assessment of the election prospects or because of Trump’s policies during his term.

Elections Politics

With US Senate Wins In Georgia, Democrats Gain Path For Rx Price Reform, But It May Be Lower Priority

Razor-thin majorities in both chambers of Congress mean Democrats can’t enact a bold agenda, and the pandemic and attendant recession mean that the initial legislative focus won’t be on Rx issues.

Elections Legislation
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