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When is a citizen not exactly a citizen? When it's a pharmaceutical company looking to increase its profits. Let me explain.
Generic drugs, the low-cost chemical twins of brand-name drugs, should be on the market soon after the big money makers' patents expire. But some generics aren't reaching stores as quickly as they could because of delays at the Food and Drug Administration and because of stalling tactics by makers of brand-name drugs. A few of the most effective--and offensive--of the tactics:
* The FDA allows any person or company to file a citizen petition challenging generic-drug approval. These petitions could raise serious safety concerns, but more often they are frivolous. When a petition is filed, the FDA delays approval until it completes an investigation, which may take more than a year. Meanwhile, the brand-name drug is the only version sold.
According to the FDA, only 3 of 42 petitions answered between 2001 and 2005 raised issues that merited changes in the agency's policies about a drug. What effect could this have had on you? It might have cost you a lot more during allergy season. Flonase, a commonly used prescription allergy medication, went off patent in May 2004. But GlaxoSmithKline, the drugmaker, stretched its profit-making window by almost two years with petitions and a legal challenge. Generic versions became available this year.
* Brand-name drug companies pay generic-drug companies to stay out of the market. It's a win-win ...