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Medical Rights Medical Rights, FDA, scientific, evidence, drug safety, pharma-FDA, US. Food and Drug Administration, FDA,  Drug Price Competition and Patent Term Restoration Act, Abbreviated New Drug Applications, ANDA

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Inspection and oversight

Ask ... not tell

The Center for Disease Control (CDC) did a risk assessment of the Atlanta Journal-Constitution's reporting on the agency. The paper was investigating morale problems, exodus of key scientists from the CDC, the agency disorganized response to Hurricane Katrina, lab animal welfare violations, plus the taxpayer-funded construction projects on Clifton Road. The paper asked for information on this assessment, the CDC refused and said "would interfere with the agency's deliberative process and have a chilling effect on employee discussions,"(1 ).

Inspections

Inspection facilities doing research is rare. The inspector general of the Department of Health and Human Services, Daniel R. Levinson indicated that federal health officials audited fewer than 1 percent of the testing sites. This was generally after the testing was complete. There is concern over the safety of test subjects. Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania said "In many ways, rats and mice get greater protection as research subjects in the United States than do humans," (2 ).

Certain medical devices such as artificial hips (which have a high risk to health ) have escaped the level of scrutiny for safety that other devices have had. Sen. Charles Grassley, R-Iowa wrote in a letter to the FDA that they "have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods,"(3 ).

The US Supreme Court ruled against the drug maker Wyeth saying FDA approved warnings did not shield drug makers from liability. The suit was brought by Diana Levine a guitarist after her arm had to be amputated due to an improper injection of the anti migraine drug Phenergan. Levine argued the warnings about the drug should have been stronger. Justice John Paul Stevens concluded the Court Majority ruling "The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims. We conclude that they do not,"(4 ).

Over a 3 year period PAC companies regulated by the FDA donated $881,635 to 33 Republican and 10 Democratic members of congress. In return they got bills to gut FDA's power to keep unsafe drugs off the market (5 ).

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Medical Rights, FDA, scientific, evidence, drug safety, pharma-FDA, US. Food and Drug Administration, FDA,  Drug Price Competition and Patent Term Restoration Act, Abbreviated New Drug Applications, ANDA