Well I guess so but if there was a meaningful codicil that brought actionable liability to the FDA's declaration of safe and effective then we may see different results. Currently any back yard lab can place a product on the medical market if the FDA says it is OK. The FDA must face stronger punitive actions where it is proven that such …
Well I guess so but if there was a meaningful codicil that brought actionable liability to the FDA's declaration of safe and effective then we may see different results. Currently any back yard lab can place a product on the medical market if the FDA says it is OK. The FDA must face stronger punitive actions where it is proven that such products are defective and the FDA has not tested adequately for safety before market release. A case in point is the HepB vaccinations of one day old infants - CDC/FDA admits that their observational safety assessment was conducted for a period of 3 days post inoculation in a trial setting! This ridiculous - a babies immune defence mechanism takes weeks to months to mature so this product should never have been released to market until observational safety studies comprising at least months were performed to validate claims of safety before market release.
Well I guess so but if there was a meaningful codicil that brought actionable liability to the FDA's declaration of safe and effective then we may see different results. Currently any back yard lab can place a product on the medical market if the FDA says it is OK. The FDA must face stronger punitive actions where it is proven that such products are defective and the FDA has not tested adequately for safety before market release. A case in point is the HepB vaccinations of one day old infants - CDC/FDA admits that their observational safety assessment was conducted for a period of 3 days post inoculation in a trial setting! This ridiculous - a babies immune defence mechanism takes weeks to months to mature so this product should never have been released to market until observational safety studies comprising at least months were performed to validate claims of safety before market release.