How a Controversial US Drug Policy Could Be Harming Cancer Patients Worldwide

August 10, 2023

(Nature) – A lot of prescriptions can be made in the time between a drug’s accelerated approval and the publication of follow-up results. If those results are negative, the drug can still be prescribed to many people before its eventual withdrawal, and even afterwards — particularly when professional medical bodies recommend its use. And accelerated approvals have an effect beyond US borders, thanks to the fact that many countries use FDA decisions to guide their own regulatory policies.

At the heart of the problem, says Lynch, is a failure of communication — both in the outcomes of follow-up studies and the nature of accelerated approval itself. “Clinicians and patients often view FDA approval as an on–off switch — either a drug is approved or it’s not,” she says. But it’s not that simple. (Read More)