To the Editor Cherla and colleagues1 use the case of cancer drugs that received accelerated approval from the US Food and Drug Administration (FDA) from 1992 to 2017 to compare the regulatory processes of the FDA, the UK National Health Service (NHS), and the European Medicines Agency (EMA). We have 2 critiques of their results.
First, the authors did not consider how the regulatory environments in both the US and Europe have changed over time. During the study period between 1992 and 2017, the EMA and the FDA sought to work collaboratively in line with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.2 Specifically, the EMA and the FDA signed an agreement to share confidential information in 2003, and they have been holding teleconferences called cluster activities several times each year to share information on cancer drug reviews and marketing authorization applications. As a result, the percentage of drugs approved by both the EMA and the FDA has increased from 60% in 2006 through 2008 to 90% in 2016.2 Still, there are differences between the EMA and the FDA in terms of the basis upon which they approved the drugs. For example, the EMA has increasingly used health-related quality of life as an alternative outcome to survival rate.3 Although the authors noted the weaknesses of accelerated approval using surrogate end points, the decision of the EMA to consider such end points is the result of ongoing efforts both to achieve international harmonization and to supplement insufficient data.
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Hashimoto T, Ozaki A, Tanimoto T. The Coverage in England of US-Approved Cancer Drugs. JAMA Intern Med. 2021;181(9):1263. doi:10.1001/jamainternmed.2021.3336
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