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Sarah Karlin-Smith

Sarah is a senior writer at the Pink Sheet, specializing 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. 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.

Latest From Sarah Karlin-Smith

She Didn’t Need To Be Commissioner: Janet Woodcock’s Transformative Legacy

She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.

FDA Leadership

Cures 2.0 Would Mandate More FDA Centers of Excellence But Oncology-Style Funding Gaps Could Doom Plan

The two new intercenter institutes, one to focus on a common group of diseases and the other on rare diseases, appear to be unfunded mandates, which could hinder the agency’s ability to get them up and running.

FDA Legislation

‘A Game Changer:’ Cures 2.0 Would Provide $11bn In ‘Subscription’ Contracts For New Antibiotics

The PASTEUR Act would delink some of an antibiotic’s revenue from prescription sales, with the goal of revitalizing the antibiotic pipeline with additional private investment while encouraging good public health stewardship of critically needed medicines.

Legislation Reimbursement

No Reservations: CDC Advisors Clear Pfizer COVID Vaccine For Kids With More Enthusiasm Than FDA Panel

CDC Director Walensky’s sign off on ACIP’s unanimous recommendation makes Pfizer’s COVID-19 vaccine available to all children 5 to 11 without any of the caveats some of FDA’s vaccine advisors were hoping might be added for use in this age group.

Coronavirus COVID-19 Vaccines

Winners and Losers In Democrat’s Mega Social Spending Package

Industry almost certain to avoid its worst pricing reform fears, but some post-exclusivity drugs may still be subject to negotiations under the most recent iteration of Build Back Better. Meanwhile, rare disease development incentives get cut and new funding is doled out for FDA.

Pricing Debate Legislation

Pfizer COVID Shot: Unanimous Vote Obscures Reservations About Vaccinating All Children 5-11

Many of US FDA's outside vaccine advisors wanted to wait for more data before widespread inoculations of kids 5-11, but felt some high-risk populations should get access to vaccine right away. They urged CDC to provide additional guidance on which children should be targeted.

Advisory Committees Vaccines
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