Food and Drug Administration

SCOTUS: No standing in challenge to mifepristone changes (FDA v. AHM)

2024-06-13 00:00:00 +0000 UTC | Importance: 6/10

The Supreme Court unanimously held the plaintiffs lacked Article III standing to challenge FDA’s 2016/2021 actions on mifepristone, leaving the agency’s changes in place. Justice Kavanaugh delivered the opinion, with the Court finding that the Alliance for Hippocratic Medicine failed to …

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Former FDA Commissioner Stephen Hahn Joins Moderna Backer Flagship Pioneering

2021-10-01 00:00:00 +0000 UTC | Importance: 8/10

Former FDA Commissioner Stephen Hahn, who led the agency during the Emergency Use Authorization of Moderna’s COVID-19 vaccines, took an executive-level position as Chief Medical Officer with Flagship Pioneering, the venture capital firm that launched Moderna. This transition occurred six …

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FDA Commissioner Scott Gottlieb Joins Pfizer Board After Leaving Agency

2019-06-27 00:00:00 +0000 UTC | Importance: 8/10

Scott Gottlieb, former FDA Commissioner, joined Pfizer’s board of directors on June 27, 2019, just 85 days after leaving the FDA. The move sparked significant criticism about the ‘revolving door’ between government regulatory agencies and pharmaceutical companies. Gottlieb will …

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FDA Approval of OxyContin Reveals Systemic Regulatory Capture by Purdue Pharma

1995-12-12 00:00:00 +0000 UTC | Importance: 9/10

In a landmark case of regulatory capture, Dr. Curtis Wright IV, leading the FDA’s Division of Anesthetic, Critical Care, and Addiction Drug Products, approved OxyContin with controversial language that misrepresented the drug’s addictive potential. Wright held private meetings with …

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FDA Prescription Drug User Fee Act Creates Financial Dependence on Pharmaceutical Industry

1992-10-29 00:00:00 +0000 UTC | Importance: 9/10

The Prescription Drug User Fee Act (PDUFA) of 1992 fundamentally restructured FDA drug approval financing by creating a direct financial relationship between pharmaceutical companies and regulators. The Act mandated drug companies pay fees to fund FDA drug reviews, which eventually comprised up to …

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