Drug-Safety

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