FDA fails to prove generic drugs

The Bush policy to wreck our government continues. The FDA is on the carpet, to put it generically, about its failure to adequately regulate generic drugs.

Neuropsychiatrist Dr. Giuseppe Borgheini in a 2004 article published in the journal Clinical Therapy documented differences in samples of brand-name and generic drugs and found three popular generic formulations “either failed to release the correct dose to patients’ bloodstreams or eventuated in higher rates of “breakthrough seizures.” [emphasis added]

“…the agency demands little clinical evidence that a proposed generic drug will work the same as a pioneer drug in a broad cross section of real patients.

“The agency conducts quality-control tests on generic samples periodically after marketing begins, and patients and physicians can report problems with a generic drug…. But neither generic-drug manufacturers nor the FDA does post-marketing studies that might indicate patients are responding differently to a generic than to its brand-name counterpart.

LATimes doing what big papers do:

The agency’s measurement of a drug’s active ingredient in the body is too relaxed.

There are no “realistic trials” or follow-up studies within patient populations.