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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

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Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the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.

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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.

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Don’t Stop Manufacturing Because Of An Inspection, FDA’s Cavazzoni Says

The FDA drug center director is encouraging manufacturers to contact the agency’s shortage surveillance team before making rash decisions during or right after an inspection. 

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The Future of ACIP: CDC Vaccine Policy Lead Looks Beyond COVID

The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in the future. 

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JNJ, BMS’s IRA Loss Is First Time Court Rejects Industry’s First Amendment, Takings Claims

The fourth court loss for pharma in industry's attempts to kill Medicare’s drug price negotiation program adds to the list of reasons courts have rejected legal challenges to the Inflation Reduction Act.

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Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

The Centers for Disease Control and Prevention’s ACIP is not able to take on all vaccine-like preventative medicines and still has to grapple with how to handle therapeutic vaccines. 

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