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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

US FDA Loss In Device Case Might Have Implications For Agency’s Work On Off-Label Rx Promotion

While the statutes at issue in the case, which revolved around banning just one use of a medical device, do not govern drugs, experts on FDA law said the decision addressing a product’s intended use and regulation of the practice of medicine could have some impact on the agency’s Rx oversight powers.

Legal Issues Advertising, Marketing & Sales

And Then There Were Three: Woodcock Offers Another Explanation For Aduhelm’s Labeling Fiasco

Acting US FDA Commissioner says it is standard for the Office of Neuroscience to issue broad labels like the one originally granted to Biogen’s new Alzheimer’s drug, but the agency declined to answer follow-up questions on such a policy. Woodcock continued to defend Aduhelm’s accelerated approval but conceded that the process might have been improved in an unusually tense public appearance.

Leadership Drug Approval Standards

Politics Is US FDA Commissioners’ Biggest Challenge, Ex-Trump Agency Head Hahn Says

In a Pink Sheet interview, Stephen Hahn also discusses the unique risk-benefit calculations that may come into play for the ‘preemptive’ therapeutics he hopes to spearhead in his new position at Flagship Pioneering and his tendency to follow in the career path of another former commissioner, Scott Gottlieb.

FDA Leadership

Importation, Pay-For-Delay Reform Backed By Biden Order; March-In Rights For Pricing Suggested

The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.

Pricing Debate Intellectual Property

Importation, Pay-For-Delay Reform Backed By Biden Order; March-In Rights For Pricing Suggested

The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.

Pricing Debate Intellectual Property

Drug Pricing Reform: Now It Is HHS Secretary Becerra’s Turn

After months of reticence about his Administration's plans for tackling drug pricing, Biden's executive order offers some clues about what might be in store and what kind of timeline they are working with. 

Pricing Debate Reimbursement
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