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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

Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks

Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.

Coronavirus COVID-19 FDA

COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel

From next-generation vaccine technology to safety data and global harmonization, what isn’t in the Vaccines and Related Biological Products Advisory Committee preview documents and on the 26 January meeting agenda may be just as important as what is.

Advisory Committees Coronavirus COVID-19

FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’s Advice

In a memo to Commissioner Califf and Chief Scientist Bumpus, Celia Witten focuses the final Makena decisionmakers on the key factors she believes should be used to determine the drug’s market status.

Post Market Regulation & Studies Drug Approval Standards

US FDA Mulls Granting Regulated Industry Flexibility To Respond To Misinformation

The rapid pace with which inaccurate information can spread on social media may necessitate loosening some of FDA’s regulations on sponsors to let them respond, Commissioner Robert Califf said at the J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.

Advertising, Marketing & Sales FDA

Califf: Decades Of Follow-Up Necessary For Gene Therapy

FDA Commissioner Califf acknowledges that regulatory pathways for gene therapies are still being developed and that many factors outside of the modality impact agency requirements as he emphasized the need for long-term follow up due to the unknowns of gene modification.

Gene Therapy Regenerative Medicine

Reassuring Safety Inquiry But Botched Comms Leads To Mixed Headlines For Pfizer Bivalent Vax

US vaccine surveillance systems were triggered, but so far further investigation clears the bivalent COVID vaccine of any new safety concern. CDC and FDA’s attempt to control the narrative appears to have backfired, however, making what looks to be a non-issue more controversial than it needed to be due to limited public communication.

Drug Safety Coronavirus COVID-19
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