In an interesting article, the Los Angeles Times yesterday discussed the tactics that some companies use to delay or derail the process used by the FDA to approve drugs for generic manufacture. When a company's initial drug patent expires, any other drug company may begin making and selling generic versions of the formerly protected drug. These generics are cheaper than the name brand, and usually represent a large loss of revenue for the company making the more expensive name brand version.

The FDA requires that all generic drugs show "bioequivalence" to the name brand. That is, they must contain the same active ingredients and must be equally effective at treating their target disease. A complicated petition system that was originally created to allow citizens and scientists to voice concerns about a particular generic drug is now being used by some large pharmaceutical companies to delay the production of competing drugs. Some companies are filing these "citzen petitions" themselves. Any time a petition is filed, the FDA is obligated to do a mandatory review, which can take months, or even years. During this review process the original drug patent is prevented from expiring, so the company making the name brand drug remains the only supplier of the medicine in question.

Most of the petitions filed by drug companies are based on the question of whether or not a competing company will be physically able to manufacture an adequate amount of medicine to meet projected needs. But, many within the system say this is a smokescreen, and that the only goal in filing these petitions is to delay the release of generic competition. While clearly unethical, if true, questions are now being raised about whether the practice might be illegal as well.

In addition to delaying the production of generic equivalents, the process of delay and review has been cited as an attempt to raise suspicion about generic drugs among the public. Lawmakers are considering if, and how, to refine the petition process.

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