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HHS Nominee Azar And The Taint Of Industry

 
• By Michael McCaughan

During the first step of the confirmation process, HHS Secretary nominee Alex Azar did a good job of framing his industry background as useful experience for tackling drug prices. But wouldn’t it be nice if everyone agreed that 10 years as Lilly was something to be proud of?

Alex Azar, Trump’s HHS secretary nominee, who spoke at the Senate HELP committee 11/29/17
Alex Azar at Senate Health Committee confirmation hearing.

It says something about the current reputation of the pharmaceutical industry that the toughest questions during the Nov. 29 Senate Health Committee hearing on the nomination of Alex Azar to be HHS Secretary came from the members of the panel who are at opposite ends of the ideological spectrum: Sen. Elizabeth Warren (D-MA) and Sen. Rand Paul (R-KY).

Warren and Paul don’t agree on much. But they both agreed during the hearing that Azar’s background as an executive with Eli Lilly raises important questions about whether he can...

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Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

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