Fda

FDA Vaccine Chief Vinay Prasad Circulates Unsubstantiated Memo Claiming COVID Vaccines Killed At Least Ten Children

2025-12-04 00:00:00 +0000 UTC | Importance: 9/10

Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), circulates an internal memo to FDA staff asserting that COVID-19 vaccines caused “at least 10 deaths in children” and calling for sweeping changes to vaccine regulation—despite providing no …

Dr. Vinay Prasad FDA Center for Biologics Evaluation and Research (CBER) Robert F. Kennedy Jr. FDA Commissioner Martin Makary FDA Scientists fda vaccines public-health vaccine-safety disinformation +5 more

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

2025-04-01 00:00:00 +0000 UTC | 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

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 …

Stephen Hahn Flagship Pioneering Moderna Food and Drug Administration (FDA) Noubar Afeyan +1 more regulatory-capture pharmaceutical-industry revolving-door covid-19 fda

Johns Hopkins Study Exposes Orphan Drug Act Gaming - Seven of Top 10 Drugs Exploiting Tax Breaks for Rare Diseases

2015-11-19 00:00:00 +0000 UTC | Importance: 9/10

Johns Hopkins researchers published findings demonstrating that pharmaceutical companies were systematically gaming the 1983 Orphan Drug Act by obtaining orphan drug designations—intended for treatments of rare diseases affecting fewer than 200,000 Americans—for blockbuster drugs generating billions …

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New England Compounding Center Fungal Meningitis Outbreak Kills 64, Sickens 798 - FDA and State Regulators Ignored Decade of Violations

2012-09-01 00:00:00 +0000 UTC | Importance: 9/10

The Centers for Disease Control and Prevention began investigating a multistate fungal meningitis outbreak in September 2012 that ultimately killed 64 people and sickened 798 individuals across multiple states who received contaminated methylprednisolone steroid injections from the New England …

New England Compounding Center Barry Cadden FDA Massachusetts Board of Pharmacy CDC +1 more pharmaceutical-industry regulatory-capture fda healthcare public-health +1 more

FDA Arthritis Drug Reviewer Jeffrey Siegel Joins Genentech After Approving Company Tocilizumab

2010-12-15 00:00:00 +0000 UTC | Importance: 7/10

Jeffrey Siegel, an FDA staff member specializing in arthritis drug reviews, oversaw the 2010 approval of Genentech tocilizumab (Actemra) for arthritis treatment. Within months of the approval, Siegel left the FDA to join Genentech and its parent company Roche as director of the division that …

Jeffrey Siegel FDA Genentech Roche Actemra regulatory-capture pharmaceutical-industry fda revolving-door drug-approval

FDA Whistleblower David Graham Testifies on Vioxx Cover-up Before Senate

2004-11-18 00:00:00 +0000 UTC | Importance: 9/10

FDA epidemiologist Dr. David Graham delivered explosive testimony before the U.S. Senate Finance Committee, declaring that ’the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.’ Graham revealed that his study showed …

Dr. David Graham FDA Merck U.S. Senate Finance Committee Government Accountability Project regulatory-capture fda pharmaceuticals whistleblower vioxx +2 more

Merck Withdraws Vioxx After Concealing Heart Attack Risk, FDA Failure Causes Estimated 28,000-55,000 Deaths

2004-09-30 00:00:00 +0000 UTC | 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

FDA Modernization Act Accelerates Drug Approvals and Expands Direct-to-Consumer Advertising Under Pharma Pressure

1997-11-21 00:00:00 +0000 UTC | 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

FDA Approves OxyContin with Unsubstantiated Safety Claims

1995-12-20 00:00:00 +0000 UTC | Importance: 9/10

The FDA approved Purdue Pharma’s OxyContin application, including a scientifically unsubstantiated claim that delayed absorption ‘is believed to reduce the abuse liability of a drug.’ This approval occurred without clinical trials to prove the safety claim and marked the beginning …

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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 …

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

Thalidomide Scandal Drives Kefauver-Harris Amendment Strengthening FDA Drug Safety Requirements

1962-10-10 00:00:00 +0000 UTC | Importance: 8/10

On October 10, 1962, President John F. Kennedy signed the Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act, fundamentally transforming pharmaceutical regulation in the United States. The legislation, driven by the thalidomide disaster in Europe, required drug manufacturers to …

Senator Estes Kefauver Representative Oren Harris President John F. Kennedy Frances Kelsey Richardson-Merrell +1 more regulatory-reform pharmaceutical-industry public-health corporate-lobbying fda