An independent study of five experts says the FDA does not have the authority to pull dangerous drugs unilaterally, force changes in drug labels, or sanction drug companies that skimp on safety monitoring.The independent study recently published its critique in the Archives of Internal Medicine. The study also contended that the FDA lacks the money and structure to insulate itself from the influence of the pharmaceutical industry. The FDA is aware of these problems and as done very little to fix them.
For instance, take Ketek, an antibiotic prescribed for bacterial infections. Internal memos demonstrated that FDA was aware of the threat for liver damage and liver failure but released Ketek into the marketplace nevertheless. Ketek is just one of the FDA failures to cave into the power of big money pharmaceutical companies.
Both the Institute of Medicine and the five experts would ban consumer advertising of newly approved classes of drugs until they have been on the market long enough for any problems to emerge; to give the agency new powers to fine drug makers that fail to complete required safety studies; and take steps to limit conflicts of interest and broaden the range of expertise on panels appointed by the agency to review scientific data on proposed drugs. (Source: Washington Post)
