Healthy Skepticism Library item: 19118

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Gagne JJ, Choudhry NK
How Many 'Me-Too' Drugs Is Too Many?
JAMA 2011 Jan; 305:(7):711-712
http://jama.ama-assn.org/content/305/7/711.extract

Abstract:

On August 3, 2009, the US Food and Drug Administration (FDA) approved pitavastatin (Livalo), making it the eighth statin approved for use in the United States and seventh currently available for sale. This approval comes almost a quarter century after that for the first member of the class, lovastatin, 8 years after generic lovastatin was approved and 4 years after 2 additional statins, pravastatin and simvastatin, lost patent protection and generic versions of them entered the market.

“Me-too” drugs are common in numerous widely used classes, including angiotensin-converting enzyme inhibitors and selective serotonin reuptake inhibitors. As with pitavastatin, their approval may come many years after the approval of other generic drugs in the class. For example, the proton pump inhibitor dexlansoprazole was approved in January 2009, more than 6 years after generic omeprazole became available. Thus, the approval of pitavastatin raises several questions: are so many agents in a single …

Keywords:
cholesterol, ldl, clinical trials as topic, drug approval, drugs, generic, government regulation, hydroxymethylglutaryl-coa reductase inhibitors, nk 104, united states food and drug administration.