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
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Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the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.
Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length
Recently retired US FDA Principal Deputy Commissioner Janet Woodcock will be advising the Haystack Project, with the goal of helping rare disease organizations encourage creativity in drug development programs without jeopardizing regulatory success, Woodcock told the Pink Sheet in an interview.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions.
Ivermectin Settlement Brings Relief And Worry For US FDA Communications
The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.
Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses
US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.