Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

US Elections 2020

Set Alert for Elections

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New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.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

Capitol Hill Riot Draws Manufacturing Group’s Call For Trump’s Removal

PhRMA and BIO are members of the National Association of Manufacturers, which made the statement urging the 25th amendment be invoked.

Elections Politics

Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency

Unintended silver lining of pandemic-generated innovation has brought the agency to an opportunistic fork in the road, and the commissioner choice will be consequential in determining the path forward.

FDA Leadership

US FDA Faces Succession Questions As Hahn’s Departure Nears

Plan specifying the acting head of FDA until new commissioner is confirmed references senior positions that no longer exist.

FDA Leadership

Happy Holidays: ‘Most Favored Nation’ Rule Effective Date Likely To Be Delayed

Either through the courts or a postponement by the Trump administration itself, the Medicare Part B rule seems destined to remain dormant instead of going into effect in January as scheduled.

Pricing Debate Regulation

US FDA Finds There’s No Vaccine Against Politics

Instead of celebrating the EUA for Pfizer/BioNTech’s COVID vaccine, officials at FDA and Operation Warp Speed once again have to answer questions about President Trump’s apparent interference in the process. But while Joe Biden isn't likely to rage-tweet about the agency, the incoming administration so far hasn't shown that much respect or understanding of FDA processes either.

Elections FDA
UsernamePublicRestriction

Register