Its time to look at the faces of lives lost… In the early 1990s, faced with protests by AIDS activists about the glacier-like approval of potential life saving drugs, the Clinton administration changed the FDA drug approval process. They allowed pharmaceutical companies to “fast track life-saving” drugs by absorbing the extra costs involved. The unintended [...]
The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27). The case involves Diana Levine, who lost her [...]
Experts Suggest Link Between Warnings and Startling New Trend Suicide rates for preteens and teenagers increased sharply when the Food and Drug Administration slapped a “black box” warning on anti-depressants and doctors started writing fewer prescriptions for young people, according to federal data released Thursday. The FDA’s warning, publicly debated in 2003 and enacted in [...]
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