Research Milestones
Drug Policy and Strategy Analyses to Inform R&D and Strategic Planning Decisions
1976 |
Identifies “drug lag”: delayed drug availability in the U.S. compared with the U.K. |
1979 |
Conducts first comprehensive study of the cost to develop a new drug: $54 million. |
1981 |
Demonstrates dramatic decline in effective patent life for new therapeutic compounds. |
1982 |
Completes first analysis of availability of drugs for limited populations, paving the way for the Orphan Drug Act of 1983 |
1984 |
Develops first comparison of the rate of drug safety withdrawals in the U.S. and abroad. |
1987 |
Publishes first comprehensive analysis of the FDA’s practice of requiring post-approval research as a condition of approval. |
1991 |
Updates its seminal drug cost study: it now costs $231 million to develop a new drug. |
1993 |
Develops first international comparison of biotechnology product discovery, development, and marketing rates in the U.S., Europe, and Japan. |
1995 |
Publishes first comprehensive analysis of biotechnology success rates. |
1996-97 |
Provides data and public testimony at Congressional hearings that led to passage of the FDA Modernization Act of 1997(FDAMA). |
1997 |
Completes comprehensive analysis of FDA/sponsor meetings, showing that meetings reduce the time of new drug development. |
1998 |
Publishes analysis showing impact of the Prescription Drug User Fee Act of 1992 (PDUFA) on drug development times. |
1999 |
Provides first comprehensive analysis and review of FDAMA’s pediatric research incentive program. |
2000 |
Publishes first comparative analysis of new drug and biopharmaceutical approval times under the Centralized Procedure of the European Medicines Evaluation Agency (EMEA) and the U.S. FDA. |
2001 |
Updates its ongoing analysis of average cost of pharmaceutical R&D. It now costs $802 million to develop a new drug and bring it to market. |
2003 |
Provides first assessment of the impact of the FDA’s new fast track program on total development times. |
2004 |
Completes analysis on the economics of follow-on drug development and incremental innovation. |
2005 |
Provides quantitative evidence demonstrating the lack of correlation between drug safety withdrawals and speed of regulatory approval. |
2006 |
Publishes first comprehensive estimate of the average cost of developing a new biotechnology product, and pegs it at $1.2 billion. |
2007 |
Publishes extensive analyses on oncology drug R&D. Overall approval success rate is 8%. |
2008 |
Publishes quantitative analysis demonstrating that U.S. drug plans, in covering 88% of drugs in six specific therapeutic areas are non-compliant with Medicare regulations. |
2009 |
Updates its ongoing analysis of new drug clinical success rates. Overall clinical success rates have fallen to 16%. |
2010 |
Documents integration of orphan drug development into drug company portfolios, representing 25% of all new approvals, and a doubling of designations in past decade. |
2011 |
Provides first analysis documenting lack of clinically useful diagnostics and how it is hindering growth in personalized medicines. |