Food and Drug Administration (FDA)

Food and Drug Administration (FDA)

HHS Lays Off 10,000 Federal Health Workers at NIH, FDA, and CDC in RFK Jr. Restructuring

| Importance: 9/10

Following the Supreme Court’s decision authorizing federal workforce reductions, HHS officially laid off approximately 10,000 employees at the National Institutes of Health, Food and Drug Administration, and Centers for Disease Control and Prevention. The restructuring consolidated 28 …

Department of Health and Human Services (HHS) Robert F. Kennedy Jr. National Institutes of Health (NIH) Food and Drug Administration (FDA) Centers for Disease Control and Prevention (CDC) public-health institutional-dismantling layoffs nih fda +1 more
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McKinsey Agrees to $650 Million Criminal Settlement for Role in 'Turbocharging' Opioid Sales for Purdue Pharma

| Importance: 9/10

McKinsey & Company agrees to pay $650 million to settle federal criminal and civil investigations into its role in helping Purdue Pharma ’turbocharge’ sales of OxyContin, the highly addictive opioid painkiller at the center of America’s overdose epidemic. This marks the first …

McKinsey & Company U.S. Department of Justice Purdue Pharma Martin Elling Food and Drug Administration (FDA) mckinsey opioid-crisis purdue-pharma consulting-scandal corporate-crime +4 more
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SCOTUS: No standing in challenge to mifepristone changes (FDA v. AHM)

| 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

| 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 …

Stephen Hahn Flagship Pioneering Moderna Food and Drug Administration (FDA) Noubar Afeyan +1 more regulatory-capture pharmaceutical-industry revolving-door covid-19 fda
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Merck Withdraws Vioxx After Concealing Heart Attack Risk, FDA Failure Causes Estimated 28,000-55,000 Deaths

| Importance: 9/10

Merck voluntarily withdraws Vioxx (rofecoxib) from the market after concealing evidence that the blockbuster arthritis drug increases heart attack and stroke risk. Internal company documents reveal that Merck knew of cardiovascular dangers years before withdrawal, while the FDA failed to act on …

Merck Food and Drug Administration (FDA) David Graham Raymond Gilmartin healthcare pharmaceutical-industry regulatory-capture fda drug-safety +1 more
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FDA Modernization Act Accelerates Drug Approvals and Expands Direct-to-Consumer Advertising Under Pharma Pressure

| Importance: 7/10

President Clinton signs the FDA Modernization Act (FDAMA), codifying accelerated drug approval pathways developed during the AIDS crisis while expanding provisions favorable to pharmaceutical manufacturers including streamlined advertising approval. The law accelerates the transformation of FDA from …

Bill Clinton Pharmaceutical Research and Manufacturers of America Food and Drug Administration (FDA) James Jeffords healthcare pharmaceutical-industry regulatory-capture fda drug-safety
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FDA Approval of OxyContin Reveals Systemic Regulatory Capture by Purdue Pharma

| 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 …

Curtis Wright IV Purdue Pharma Food and Drug Administration (FDA) Division of Anesthetic, Critical Care, and Addiction Drug Products Department of Justice regulatory-capture pharmaceutical-industry opioid-crisis fda-corruption public-health
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FDA Prescription Drug User Fee Act Creates Financial Dependence on Pharmaceutical Industry

| 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 …

Food and Drug Administration (FDA) Pharmaceutical Research and Manufacturers of America U.S. Congress Pharmaceutical Companies regulatory-capture pharmaceutical-industry fda government-funding institutional-transformation
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