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.
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