The latest report from The Tufts Center for the Study of Drug Development, which states that the average cost of developing a new drug is $2.56 billion, has been roundly criticised by Médecins Sans Frontières.
The Tufts figure per compound, up from $802 million in 2003, is based on “average out-of-pocket cost” of just under $1.40 billion and time costs (expected returns that investors forego while a drug is in development of $1.16 billion. The analysis argues that the cost of post-approval studies (to test new indications, formulations, dosage strengths and regimens) and to monitor safety and long-term side effects in patients required by the US Food and Drug Administration is $312 million.
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