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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

Top FDA Staff Are Pushing Review Teams To Be Comfortable With Regulatory Flexibility

Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

Drug Approval Standards Rare Diseases

Gene Therapy And Accelerated Approval: US FDA Mulls Pooling Data To Shrink Postmarket Studies

The head of CBER's Office of Therapeutic Products also touted hiring achievements and new communication plans with sponsors at an Alliance for Regenerative Medicine meeting. 

Post Market Regulation & Studies Gene Therapy

Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival

Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.

Drug Approval Standards FDA

Medicare Rx Negotiation More Insulated From SCOTUS Fallout, But Some Key CMS Decisions Could Be Vulnerable

Experts expect litigation challenging Medicare’s definitions of single-source drug and bona fide marketing to get a boost from recent Supreme Court rulings, but overall, the IRA is likely better positioned in a post-Chevron world than older Medicare statutes.

Medicare Litigation

Congress Pushes US FDA On Trial Diversity, Accelerated Approval In Approps Report

The House Appropriations Committee indicates in fiscal year 2025 appropriations report language that lawmakers will closely monitor the FDA’s implementation of clinical trial diversity action plans. 

Legislation Rare Diseases

FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says

A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics. 

Legislation Regulation
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