Sarah Karlin-Smith

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

US FDA, HHS Leadership Push Broader Testosterone Indication At Expert Panel

At an expert panel overwhelmingly composed of people favoring expanded testosterone use and loosened safety warnings, career FDA staff suggested new clinical trials would be required to approve some of the changes.

CAR-T Standards Raised As US FDA Continues Policymaking Via Journal Article

Experts said the impact of the planned approval standard changes are difficult to assess given the potential for flexibility outlined in the JAMA article, as the FDA again eschews guidance and public comment in making new policy.

Pink Sheet Podcast: Understanding the US FDA’s CDER Leadership Shuffle

Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.

Høeg Doubles Down On Prasad’s US FDA Vaccine Overhaul

At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.

Ex-CDC Official: ACIP Hep B Decision Could Destabilize Access To Other Children’s Vaccines

Because combination vaccines remain in the US childhood vaccine schedule, ACIP's reconsideration of hepatitis B vaccine dose timing could impact uptake of other immunizations, Demetre Daskalakis told the Pink Sheet.

US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.