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
Following a memorable cancer drug advisory panel meeting where FDA explained how accelerated approvals may be more at risk due to changing standard of care, ChemoCentryx’s ANCA-vasculitis treatment runs into trouble because of another drug’s changing indication during their Phase III study.
Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.
Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It is also not clear whether it is an ominous sign for other industry battles in the US, including the drug pricing debate.
Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.
Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.
Phase III trial was statistically significant, but US FDA argues complex study design makes it unclear that ChemoCentryx’s avacopan offers a clinically meaningful benefit, including a safety advantage, for ANCA vasculitis. Agency had tried to direct company to better designed trials earlier in development program.