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Sarah Karlin-Smith

Sarah is a senior writer at the Pink Sheet, specializing in the policy and politics that affect the pharmaceutical industry. She covers the US Food and Drug Administration, Centers for Medicare and Medicaid Service and Congress. Her work explores how government policies influence how drugs are developed and approved, what diseases are prioritized by scientists, and who gets access to medicines and at what cost. Sarah has covered health care since 2011. Prior to returning to the Pink Sheet in March 2020, she covered health policy at Politico for five years.

Latest From Sarah Karlin-Smith

Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate

Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.

FDA Review Pathway

US FDA Lowers Bar for Latest COVID Monoclonal Antibody Authorization

Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.

United States Biologics

Califf Pledges To Counter Misinformation As He Returns To US FDA Helm

FDA commissioner's commitment to counter misinformation also appears to include pledge to ensure agency is driven by science-based decisions, not politics.

FDA Leadership

Califf Kicks Off Commissionership With Pledge To Counter Misinformation

New FDA commissioner commitment to counter misinformation also appears to include pledge to ensure agency is driven by science-based decisions, not politics.

FDA Leadership

Republicans Turn Their Backs On Califf

A visual comparison of Robert Califf’s US FDA Commissioner confirmation votes in 2016 and 2022.

FDA Leadership

Califf Limps Toward FDA Commissioner Confirmation

Final Senate vote on Robert Califf’s nomination to lead the US Food and Drug Administration is expected 15 February after Califf narrowly squeaked through a procedural vote. The final vote is expected to be even tighter.

FDA Politics
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