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
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.
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.
FDA commissioner's commitment to counter misinformation also appears to include pledge to ensure agency is driven by science-based decisions, not politics.
New FDA commissioner commitment to counter misinformation also appears to include pledge to ensure agency is driven by science-based decisions, not politics.
A visual comparison of Robert Califf’s US FDA Commissioner confirmation votes in 2016 and 2022.
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.