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
Throckmorton is known for enhancing the FDA’s drug shortage work by building bridges between the compliance and quality teams, as well as opioid oversight.
The confirmatory trial for the anticoagulant reversal agent raised safety and efficacy concerns from the agency.
Expected HHS Secretary nominee Robert F. Kennedy Jr.'s dislike of user fees and interest in major FDA reforms could come to a head in the 2027 PDUFA reauthorization.
Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS, and FDA Commissioner Robert Califf’s request that industry help preserve the agency status quo.
The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.
In the second part of the Pink Sheet’s interview with the former senior FDA official, Woodcock says her push to create a rare disease drug approval pathway that wouldn’t require a randomized controlled trial will not return the agency to “an anecdote standard” or cause a downward creep in the evidentiary standard for approval.