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.

New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.

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

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.

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.

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.

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.

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

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.

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

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.

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.