Costs of Research and Development
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CPTech Analysis of Drug Development Costs
- July 14, 2006. James Love, CPTech Drug Development Blog.
Size of trials by status (S or P) - Some 2004 FDA and Parexcel data compared.
- November 30, 2001. Press release on Tufts study and IRS data.
IRS Data Shows Drug Industry Cost Estimates Exaggerated. Also, see the
CPT Comments on the news coverage of the report, and how the coverage
dealt with three different aspects of the Tufts report:
- November 28, 2001.
Costs of Human Use Clinical Trials:
Surprising Evidence from the US Orphan Drug Act.
- April 2, 2000. James Love. Draft paper.
How Much does it cost to develop a new drug
- January 13, 1997, James Love in Marketletter,
"Call for More Reliable Costs Data on Clinical Trials." The Article finds industry
estimates of pharmaceutical drug development costs at odds with data
from U.S. Tax returns on Orphan Drug clinicial trials, and NIH funded
clincial trials. Also interteresting is
PhRMA's response to the article.
Other Analysis of Drug Development Costs
- October 19, 2006. Government Accountability Office report requested by Rep. Waxman,
Sen. Durbin and Sen. Kennedy. New Drug Development - Science, Business, Regulatory
and Intellectual Property Issues Cited as Hampering Drug Development Efforts.
- November, 2004. Jim Gilbert, Preston Henske and Ashish Singh for Bain % Co.
Paper published in Windhover Information, Inc.'s In Vivo Business and Medicine Report.
The Rising Cost of New Drugs.
- June 23, 2004. Cutting Edge Information.
Clinical Trials Consume 37% of Pharmaceutical R&D Spending. This is a press
release announcing the publication of a report - which is only available for
purchase - titled
Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity.
- June 13, 2003.
Letter from Senators Daschle, McCain and Kennedy to the GAO requesting a cost
study of HIV/AIDS drugs.
- February, 2003. Joseph A. DiMasi, Ronald W. Hansen, and Henry G.
Grabowski. Journal of Health Economics.
The price of innovation: new estimates of drug development costs.
This is the study that concludes that the average capitalized cost
of R&D for a New Chemical Entity is $802 million.
The authors are from the Tufts University Center for the Study of
Drug Development, which is perhaps the best known
source of information about drug development costs.
Research at this center is sometimes funded by the pharmaceutical
industry, and its reports often are used to support industry lobbying
efforts. The Center does not feature much work on the issue
of the government's role in the development of new drugs, or
attempt to examine issues such as the degree to which private
sector research is focused on non-essential products. However,
the rigor of many studies is commendable, and the staff is helpful
on a wide range of important topics, if you know the right questions
- July 17, 2002. Families USA Report.
Profiting from Pain: Where Prescription Drug Dollars Go.
- December 3, 2001. Gardiner Harris for the Wall Street Journal.
Cost of Developing New Medicine Swelled to $802 Million, Research
- October 2001. The Golobal Alliance of TB Drug Development.
The Economics of TB Drug Development.
- July/August 2001. Bob Huff. GMHC Treatment Issues Volume 15, Number 7/8.
What Does R&D Really Cost? Accompanied by a one-page summary document:
Estimating HIV Drug Development Costs from Publicly
- July 23, 2001. Public Citizen.
Rx R&D Myths: The Case Against the Drug Industry's R&D "Scare Card."
The following documents are related to this study:
- July 2001. Report by Families USA.
Off the Charts: Pay, Profits and Spending by Drug Companies.
- 1993, the Office of Technology Assessment's widely
Pharmaceutical R&D: Costs, Risks, and Rewards, OTA-H-522, GPO stock
#052-003-01315-1, NTIS order #PB93-163376. The estimates most
often quoted from this study are based upon data from the Tufts Center,