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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

Lower Reimbursement For Accelerated Approval Drugs May Get Push From ICER

ICER President Steve Pearson expresses interest in setting drug costs for accelerated approval drugs low with price increases based on confirmatory evidence ahead of upcoming white paper from the group.

Pricing Debate Cost Effectiveness

Woodcock: COVID Is Not The Time For Structural Changes At US FDA

Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.

FDA Leadership

PhRMA’s ‘Better Way:’ Remember COVID Success, Tweak Part B, And Bash HR 3

Trade group’s new agenda offers few original solutions to tackle US drug costs, relying on old standbys and reminders of what medical innovation might be lost if industry is financially targeted by policy makers with a strong nod to drug manufacturers role the current pandemic.

Pricing Debate Politics

Accelerated Approval, Real World Evidence Pilot From ICER, Aetion Picks HAE As First Therapeutic Area

ICER signals how it will pick other therapies for pilot in interview with Pink Sheet. Aetion believes project will help 'pressure test' the RWE field and show health plans and providers the value of using real world evidence to supplement clinical trial data.

Real-World Evidence Cost Effectiveness

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

Coronavirus COVID-19 Review Pathway

Pharma’s Upcoming Messaging Battles In US Pricing Debate Foreshadowed In CBO Report

Our infographic offers the top takeaways from Congressional Budget Office report that says lower drug prices would decrease industry’s spend on research and development, while rejecting claim that costs of R&D set or impact a particular medicines price.

Pricing Debate Research & Development
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