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
‘If I had been in the room, I would have voted yes,’ CDC director says of ACIP. ‘This was a scientific close call. ... And that was how my recommendations came out after listening to all of their scientific deliberations.’
ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.
Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs
US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.
Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough
Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear if Pfizer has made the case to FDA that a booster dose is needed at this time or that they provided enough safety data.
With potentially less flexibility and a simpler calculation on the benefit-risk of approving COVID vaccine boosters, FDA could punt the more challenging questions like whether boosters are needed now and for which populations, along with global equity and public health considerations to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
As questions of political interference continue to swirl around the issue of whether additional vaccine shots will be needed, the Biden administration is facing communication challenges commonly seen with his predecessor, Donald Trump.