All who want and need lower expenses for prescription and over the counter drugs spend $28 billion a year on generic drugs. They don't always get what they bargain for.

There are loopholes in the U.S. Food and Drug Administration's approval process regarding the re-modeling of patented brand-name drugs into generic imitations that are sold at lower prices than the patented products. The fault in the process seems to have two specific areas: one pushes to have the generic products brought to market swiftly to satisfy market demand, and the desires of the drug developers and the less than original testing and test result disclosure requirements placed upon the imitation generic drug producers.

In regards to the first problem, the industry is salivating at the near fifty patented drugs that will loose their patent protection in five years. There is a huge market just up ahead eagerly awaiting alternative drugs to reduce costs of care. With this large market opportunity, it is understandable that drug manufacturers would want any testing or evaluation to be as streamlined as possible, and any testing or reporting to be as inexpensive as possible.

That is a problem now because the process is too streamlined. For instance, there have been a number of drugs that where brought to the market and proved ineffective because they did not have the chemical equivalency of the original drug they were reported to replace. How could this happen? If an FDA drug runs off patent protection and a producer brings a generic to replace it, shouldn't it be the chemical equivalent of the original and shouldn't that continuity be tested as rigorously as any other potent drug? Presently they are not. And that is a serious loophole.

The second problem is that the generic drug producer is not obligated to give full disclosure of testing and trail data regarding the copy drugs development. This allows the developers of the generic the opportunity to not report or hold back information that could require more intensive testing or slow the approval process by not reporting negative data to the federal investigators. What kind of logic is that?

The FDA has committed to speeding the process of generic drug approval, but has overlooked one of its primary responsibilities, insuring any drug it approves has had ample and full evaluation.