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Letter to the Editor

Extending Patents With New Indications

Lorne Basskin PharmD

To the Editor:

In your November issue, Stephen Barlas expresses his dissatisfaction with a Food and Drug Administration, Congress, and court system that refused to give AstraZeneca the tools to prevent the generic manufacturer of Crestor from selling it for the indication of homozygous familial hypercholesterolemia.1 However, he fails to see the overarching issue here. The drug was going off patent. The company was trying to effectively extend that patent by coming up with a “new indication” and locking out the generic. In fact, the indication is just a rare form of high cholesterol, a “disease” that this product, the generic, and all the competing drugs already treat. To effectively prohibit the generic from being used for the same purpose as the brand version would be a gift to the drug company, and probably unnecessary, since I am sure this drug was already being tried by doctors treating someone with high cholesterol.

The law is fine as it is. We don’t need to allow drug companies to shut out generics by using these sleight-of-hand tricks.

  • Barlas S. The push for additional orphan drugs. Can the FDA do more to encourage their development?. P T 2016;41;(11):667