The decline of science at the FDA has become unmanageable

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In a brief recent article in the British Medical Journal,1 associate clinical professor of medicine David Ross from the George Washington University highlights a troubling ‘corruption of the FDA’s scientific culture’.

He does so using the example of the approval of the drug Recarbrio by the US Food and Drug Administration (FDA) in 2019. After the thalidomide safety disaster, any FDA approval of a new drug requires proof of ‘substantial evidence’ of safety and effectiveness. The legally enforceable regulations are designed to assure ‘prescribers, patients and payers that effectiveness claims are based on science, not science fiction’.

Ross explains the FDA’s subversion of ‘the legal standard for effectiveness’ in the 2019 approval of Recarbrio with reference to the rising share of user fees, paid by the drug industry, in the FDA’s annual budget, up from less than one-tenth in 1994 to over two-thirds in 2023.

Institutional renewal of the FDA thus requires tapering its dependence on user fees and also greater transparency with improved public access to the information received by the FDA, its reasoning, and its decisions. Otherwise, we risk  returning ‘to an era when drug effectiveness was an afterthought.’

1 BMJ 2023; 381 doi: https://doi.org/10.1136/bmj.p1061 (Published 15 May 2023)

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  • Prof Ramesh Thakur

    Ramesh Thakur is emeritus professor in Crawford School of Public Policy, Australian National University. Educated in India and Canada, Ramesh has held full time academic positions at universities in Australia, Canada, Fiji and New Zealand. He is a former United Nations Assistant Secretary-General, principal writer of Secretary-General Kofi Annan’s 2002 UN reform report, a Responsibility to Protect (R2P) Commissioner and one of the three lead authors of its 2002 report on R2P. He served for five years as the Editor-in-Chief of Global Governance. His recent books include The Group of Twenty (G20) (Routledge, 2013), The Oxford Handbook of Modern Diplomacy (Oxford University Press, 2013), Nuclear Weapons: The State of Play 2015 (Centre for Nuclear Non-Proliferation and Disarmament, 2015), Nuclear Weapons and International Security: Collected Essays (Routledge, 2015), The United Nations, Peace and Security: From Collective Security to the Responsibility to Protect (Cambridge University Press, 2006 and 2017), and The Nuclear Ban Treaty: A Transformational Reframing of the Global Nuclear Order (Routledge, 2022).

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