Sarah Karlin-Smith
Senior Writer
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
Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation
Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.
AI And Postmarket Surveillance: A Signal To Noise Challenge
The ability to quickly scour the internet for comments on drugs may make it challenging to weed out true adverse events from junk as Senate Republicans consider AI-related changes to FDA's authority.
US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals
CBER’s Nicole Verdun said the FDA is using the principles of the platform approach in situations that don’t qualify for the agency’s new incentive.
‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks
FDA leadership has generally seemed apprehensive of going too hard on companies that don’t meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course.
Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says
Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.
Cost Of Reviewing Drugs With AI Is ‘Prohibitive’ For US FDA
A public-private partnership or other solution may be needed for the FDA to handle the costs of reviewing the growing number of drug applications with AI and machine learning components, CDER Director Patrizia Cavazzoni said.