Drug discovery – the facts

The Tufts Center for the Study of Drug Discovery in Massachusetts provided a very full response to a request for information on the time and costs involved in developing a new drug in the US. Here's what they sent.

1 - Our 'success rates' study is available at the publisher's website, without a royalty.

http://www.nature.com/clpt/journal/v69/n5/index.html

Scan the Commentary section for DiMasi

There are two articles in the issue:

DiMasi JA: Risks in new drug development: approval success rates for investigational drugs. Clinical Pharmacology & Therapeutics 2001 May;69(5):297-307 [RS 2109]

DiMasi JA: New drug development in the United States 1963-1999. Clinical Pharmacology & Therapeutics 2001 May;69(5):286-96 [RS 2108]

The second article gives total drug development time, from discovery to approval.

2 – The following article is available at the publisher's website, and at other websites.

DiMasi JA, Hansen RW, Grabowski HG: The price of innovation: new estimates of drug development costs. Journal of Health Economics 2003 Mar;22(2):151-85 [RS 2302]

Some libraries receive the journal.

Some libraries have access to Science Direct, from Elsevier. If your institution is not a subscriber, then you will be asked for a credit card. The cost is $30.

Go to http://www.sciencedirect.com, search on DiMasi

Or use Google Scholar, http://scholar.google.com/advanced_scholar_search, search on DiMasi

3 - Drug development costs in the USA

Cost	2000/year $	2003/year $	2004/year $	2005/year $	2006/year $
Discovery to approval	802 million	848 m	868 m	899 m	930 m
Post-approval R&D*	95 million	100 m	103 m	107 m	111 m

* FDA mandated studies, does not include marketing

4 - The following study is at the link below.

DiMasi JA, Grabowski HG , Vernon J: R&D costs and returns by therapeutic category. Drug Information Journal 2004 38(3):211-23

Issue 13 Spring 08

Drug discovery – the facts

1 - Our 'success rates' study is available at the publisher's website, without a royalty.

2 – The following article is available at the publisher's website, and at other websites.

3 - Drug development costs in the USA

4 - The following study is at the link below.