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
US FDA Mum On Whether Woodcock Would Stick Around Long-Term For Califf
Woodcock’s willingness to stay on at US FDA for more than a transitional period after Robert Califf’s expected confirmation as commissioner may depend on exactly the type of authority and tasks he’d be willing to delegate to her. Plus, some other agency personnel updates.
Pink Sheet Podcast: Woodcock’s Legacy, Merck’s Oral COVID-19 Pill, 340B Case At Supreme Court
Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.
She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy
She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.
Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan
The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.
‘A Game Changer:’ Cures 2.0 Would Provide $11bn In ‘Subscription’ Contracts For New Antibiotics
The PASTEUR Act would delink some of an antibiotic’s revenue from prescription sales, with the goal of revitalizing the antibiotic pipeline with additional private investment while encouraging good public health stewardship of critically needed medicines.
No Reservations: CDC Advisors Clear Pfizer COVID Vaccine For Kids With More Enthusiasm Than FDA Panel
CDC Director Walensky’s sign off on ACIP’s unanimous recommendation makes Pfizer’s COVID-19 vaccine available to all children 5 to 11 without any of the caveats some of FDA’s vaccine advisors were hoping might be added for use in this age group.