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April 2, 2008

Newly Approved Does Not Always Mean New and Improved

JAMA. 2008;299(13):1598-1600. doi:10.1001/jama.299.13.1598

Pharmaceutical manufacturers are in business to make money, and they make money by bringing new products to market. This statement is not a value judgment; it is a simple fact. Profits are a stimulus for innovation in the pharmaceutical industry, and innovation is the basis of progress and improvement in health care.

The most profitable products for these companies are “blockbuster” drugs, which are commonly defined as drugs that generate more than $1 billion in revenue annually. Selective inhibitors of cyclooxygenase type 2 (“coxibs”) and atypical antipsychotics are 2 examples of drug classes that produced blockbuster sales. Recent controversies around both drug classes highlight some of the difficulties inherent in balancing the promise of innovation and improved care against real-world safety and effectiveness. Much has been made about the need for reform of regulatory agencies to ensure that the public is protected from unsafe drugs while still being afforded timely access to efficacious new ones.1,2 In this Commentary, we argue that regulatory reform alone is an insufficient step toward improving drug safety.

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