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US FDA Finds There’s No Vaccine Against Politics

 
• By Nielsen Hobbs

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.

Peter Marks and Stephen Hahn prepare for some tough questions at the beginning of the 12 December press conference on the EUA for the Pfizer/BioNTech COVID vaccine. • Source: Screenshot

There really was never much of a question about whether Pfizer Inc./BioNTech SE’s COVID vaccine was going to receive an emergency use authorization from the US Food and Drug Administration, but the question of when that was going to happen became dramatic on Friday morning when President Trump tweeted that FDA needed to “Get the dam vaccines out NOW. ... Stop playing games and start saving lives!!!”

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More from Elections

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

‘A Lot Of That, It’s Meant To Start A Conversation’: How To Work With Trump

 
• By Alaric DeArment and Jessica Merrill

Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.

Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step

 
• By Michael McCaughan

Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.

Trump And Tariffs Top Generic Industry Concerns

 
• By Dave Wallace

At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.

More from Legislation

Will They Or Won’t They? Tariff Questions Loom For Drugmakers

 
• By Jessica Merrill

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

US FDA Commissioner Nominee Recruiting More Hill Staff Ahead Of User Fee Reauthorization

 
• By Michael McCaughan

Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?

EU HTA Regulation: Companies Can Talk To National Authorities As ‘Substitute’ For EU-Level Advice

 
• By Eliza Slawther

Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.