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Sarah Karlin-Smith

Senior Writer

Washington, DC

Sarah specializes 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 and other parts of federal and state government. 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. She is a regular panelist on the Kaiser Health News 'What the Health' podcast. Sarah was selected for and attended a 2018 International Women’s Media Foundation reporting fellowship in Rwanda. In 2016, she attended Harvard Medical School’s media fellowship on bioethics and, in 2014, was an Association of Health Care Journalists-National Library of Medicine Fellow.

Latest From Sarah Karlin-Smith

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Even as US FDA expressed concern about the perioperative trial design, AstraZeneca’s ability to snag NSCLC indication without demonstrating the benefits of both the neoadjuvant and adjuvant phases of therapy highlights slow pace of agency policy shifts.

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Pink Sheet Podcast: What We Learned From The First Batch Of Medicare Negotiated Drug Prices

Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.

Medicare Pricing Strategies

Round 1 Of US Drug Price Negotiations Suggests Medicare Can Beat Original Part D System

CBO estimated Medicare would get 50% net price reductions under the IRA, but CMS actually garnered 22%. The CBO analysis could not account for some of the particulars of the negotiations, but some health policy experts stressed any net gain over private Part D plan negotiation is a win.

Medicare Pricing Strategies

US FDA Advisory Committee Conduct Could Take Center Stage in Lykos Appeal of MDMA Rejection

Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter. 

Complete Response Letters Neurology

Pink Sheet Podcast: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity, questions about approving a new drug that would be used with a standard of care regimen that is off-label, and the agency beginning to schedule fully in-person advisory committee meetings.

Diversity & Inclusion Advisory Committees
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