They don’t always require the minimal blood level testing that I’ve mentioned. For very water-soluble chemicals and “non-critical drugs” the FDA accepts data from in vitro studies of tablet dissolution. These cheap tests offer no protection against contaminants, too much excipient, etc. Even worse, the FDA won’t disclose which drugs it has approved solely on the basis of these “biowaivers” (secret deals).

The FDA sees its main job as getting as many generic drug applications processed as rapidly as possible. They don’t want to waste time on inspections or ordering testing of a larger number of “volunteers”. I don’t have to tell you that the metabolism of almost all drugs, including caffeine, ethanol and cannabis extracts is different in the sick and elderly. Those are the main recipients of prescription drugs.

The FDA makes no effort to limit switching from one generic to another, or even to compel pharmacies to tell us if we are switched to a new formulation. A thoughtful patient may assume that he or she got the wrong pills when they find that the new pills look different. The FDA does not require drug labeling by country of manufacture. We had serious problems with Chinese made heparin; I think that drugs made in the US, Canada or Mexico are safer than those from the lowest wage countries.

FDA regulation of drugs, although problematic, is much better than their regulations of new devices, new forms of radiation therapy, etc. FDA policies overall are similar to those of the European Medicines Agency (EMA) and Health Canada.