Should FDA change its rules to prevent another Tricor?

The Archives of Internal Medicine has made a run at the Abbott Laboratories ($ABT) fenofibrate saga. After studying years of prescription data, researchers concluded that branded versions of the drug--aka Tricor--dominated the market long after key patents expired, and even after generics hit. And that domination cost the U.S. healthcare system lots of money, the researchers contend.

The overall conclusion isn't new: It's well known that Abbott tweaked fenofibrate formulations repeatedly to spin out its hold on that market. The Archives authors describe a two-pronged strategy: Faced with a prospective generic, Abbott could sue for patent infringement, triggering the Hatch-Waxman Act's automatic 30-month delay. The company could then use that time to come up with a new version and beat the generic to market.

Then, doctors prescribing the newer formulations kept the brand alive. Easy generic substitution wasn't possible, because generic versions weren't precisely, exactly the same drug, the Archives researchers say. Generics companies didn't have the marketing muscle to persuade physicians to specify their versions when prescribing.

All of this is perfectly legal, the authors hasten to note. And then they suggest policy changes to prevent the same sort of tactics. For instance, the FDA could require follow-on formulations to go by different brand names, to make it easier for doctors and patients to distinguish them. And the study suggests that doctors make more of an effort to prescribe generics and help control costs.

- read the Medscape Medical News story (registration required)

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