Why your medicine costs so much

	SOUR TASTE  Sweetheart deals between makers of brand-name drugs and generic-drug companies jack up prices.

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 situation for both of them, since the brand-name ­company keeps its exclusivity, and the generic manufacturer gets a tidy sum for doing nothing.We consumers are the losers. For years, the Federal Trade Commission successfully enforced the antitrust laws against pharmaceutical companies, which stopped the practice cold. But recent reversals in appellate courts have weakened FTC protections and given a green light to these sweetheart deals.
  
  
• Brand-name drug companies are jumping into the generic market by repackaging their own products to go head-to-head with existing generic manufacturers. While that might seem like a good thing--in theory and generally in practice, the more competitors, the lower the price--generic manufacturers are less motivated to vie for smaller profits. The FTC is considering an assessment of both the short-term and long-term competitive effects.
  
  The FDA is struggling to keep up with generic-drug applications. In the past three years, it has built a backlog of hundreds of applications. But even if the FDA gets the $16 million to $19 million a year it says it needs to boost its efficiency, Congress must close the loopholes that let makers of brand-name drugs keep lower-cost generics off the market. When several widely prescribed medications come off patent in the next few years, the pharmaceutical companies shouldn’t have the ability to delay our access to competitively priced generics.