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
A move to cut senior FDA positions including CDER Director through the appropriations process is rare and almost certain to fail, but experts say the attempt is indicative of an environment that seems to be encouraging these personal amendments.
A US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
As New Tech Emerges For Early Research, FDA Chief Scientist Says Diversity Must Start In Preclinical Development
In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better ‘organs on a chip’ should help.
Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1
CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.
PBMs are able to leverage brand-to-brand competition across a variety of drug classes to lower costs, but that achievement and the presence of me-too drugs is more complicated than what might on its surface look like a clear win for the US health system.