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
US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments
FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.
‘The Run Is Worth The Slide:’ FDA Advisors Urge Expansion Of J&J’s CAR-T Carvykti Despite Initial Upfront Treatment Risks
Oncologic Drugs Advisory Committee also favors earlier use of Bristol-Myers Squibb’s Abecma in multiple myeloma, although some members raise concerns about lack of plateau in progression-free survival benefit and equivocable overall survival data.
Risks For Pharma Industry Remain As BIO Shifts Course On BIOSECURE Act
Trade group’s break from WuXi Apptec allows BIO to reset its lobbying approach under its new CEO but doesn’t negate the business and supply chain disruptions that biopharma would feel from the proposed legislation.
BMS And J&J CAR-Ts Flagged For Early Deaths Ahead of Back-To-Back FDA Advisory Panels
Deaths that occurred before a patient randomized to one of the CAR-T products received that treatment don’t necessarily negate the FDA’s concerns, because risks associated with administration of treatment are “integral to the benefit-risk assessment,” the agency said.
Early Alzheimer’s Guidance: FDA Puts Forth New Endpoint Possibilities for Stage 3 Disease
New draft guidance opens the door to getting a drug for Stage 3 Alzheimer’s through FDA on cognition alone.
Alzheimer’s And Surrogate Endpoints: FDA’s On A Case-By-Case Basis Per New Guidance
After Aduhelm and Leqembi rendered the 2018 guidance moot, FDA formally acknowledges the possibility of using surrogate endpoints for accelerated approval in Alzheimer’s in updated draft but says acceptability of the any endpoint will depend on details of specific therapeutic program.