The global impact of the FDA's changing approval standards

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Published: 2 Feb 2022
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Dr Bishal Gyawali - Queen's University, Kingston, Canada

Dr Bishal Gyawali talks to ecancer about the changing of evidence standards at the FDA, how they have changed over time and what it means for countries all over the world.

He mentions his recent tweet giving his opinion on what he sees as the continued erosion of evidence standards at the FDA. In the past, the FDA required evidence of the efficacy of a drug from two randomised control trials, this was then adjusted to receiving substantial results from only one trial.

The standard then was changed again to surrogate endpoints validated by survival instead of clinical endpoints, which was then replaced by progression-free survival. Single-arm trials with response rate and duration of response rate were then considered for accelerated approval.

Dr Gyawali says that the "bar was lowered" to a point that more recently the results from single-arm trials are given full approval instead of accelerated approval, which still had some future checks to it.

He opines that due to these changes of standards we may now have more quantity of cancer drugs, but the quality is questionable.

Dr Gyawali mentions a paper regarding the global consequences of the US FDA's accelerated approval of cancer drugs. He explains how these approvals adversely impact LMICs and their quality of life.

Dr Gyawali concludes by saying that the international healthcare community should stay vigilant and keep an eye on what drugs are being taken off the market in the USA.

Read the tweet Dr Gyawali mentioned here.

Read the Lancet paper mentioned in the video here.