How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation

Health Affairs

Volumn 25, Issue 5, 2006, Pages 1309-1317

  Reed, Shelby D ^a,b   Califf, Robert M ^a,c,d   Schulman, Kevin A ^a,e,f  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^d DUKE UNIVERSITY   (United States)

^e DUKE UNIVERSITY   (United States)

^f Center for Clinical and Genetic Economics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOTECHNOLOGY; DRUG INDUSTRY; ECONOMICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; INVESTMENT; LEGAL ASPECT; MASS COMMUNICATION; PHASE 3 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL (TOPIC); SAFETY; UNITED STATES;

BIOTECHNOLOGY; CLINICAL TRIALS, PHASE III; CLINICAL TRIALS, PHASE III AS TOPIC; DIFFUSION OF INNOVATION; DRUG INDUSTRY; GOVERNMENT REGULATION; HUMANS; INVESTMENTS; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33749341245     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.25.5.1309     Document Type: Article

References (27)

1. C. Baum et al., "The Spontaneous Reporting System in the United States," in Pharmacoepidemiology, 2d ed., ed. B.L. Strom (West Sussex, U.K.: John Wiley and Sons, 1994);
2. and P.B. Fontanarosa, D. Rennie, and C.D. DeAngelis, "Postmarketing Surveillance - Lack of Vigilance, Lack of Trust," Journal of the American Medical Association 292, no. 21 (2004): 2647-2650.
3. C.L. Bennett et al., "The Research on Adverse Drug Events and Reports (RADAR) Project," Journal of the American Medical Association 293, no. 17 (2005): 2131-2140.
4. C.P. Stickney and R.L. Weil, Financial Accounting: An Introduction to Concepts, Methods, and Uses, 10th ed. (Cincinnati: South-Western College Publishing, 2003).
5. F.C. Zinkhan, "Combining Net Present Value and Strategic Effectiveness to Evaluate Drug Development Alternatives," Journal of Pharmaceutical Marketing and Management 9, no. 1 (1995): 19-22.
6. For a summary of the parameters and estimates incorporated into the model, see the online technical appendix at http://content.healthaffairs.org/ cgi/content/full/25/5/1309/DC1.
7. J.A. DiMasi, R.W. Hansen, and H.G. Grabowski, "The Price of Innovation: New Estimates of Drug Development Costs," Journal of Health Economics 22, no. 2 (2003): 151-185.
8. "Establishment of Prescription Drug User Fee Rates for Fiscal Year 2005," Federal Register 69, no. 147 (2004): 46165-46168.
9. The company would not be expected to receive an incremental financial benefit or loss from its investment decision.
10. D.B. Ridley et al., "Spending on Postapproval Drug Safety," Health Affairs 25, no. 2 (2006): 429-436.
11. Note that this estimate refers to net present value at the beginning of year 1, before preclinical and clinical development of the product. As time passes, the net present value changes, because costs incurred up to that point are considered sunk costs and do not factor into the calculation of net present value.
12. Ridley et al., "Spending on Postapproval Drug Safety."
13. M.D. Rawlins, "Cutting the Cost of Drug Development?" Nature Reviews Drug Discovery 3, no. 4 (2004): 360-364.
14. "Drug Costs: Research and Development Costs: The Great Illusion," Prescrire International 13, no. 69 (2004): 32-36;
15. and U.S. Congress Office of Technology Assessment, Pharmaceutical R&D: Costs, Risks and Rewards, Pub. no.OTA-H-522, February 1993, http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9336/9336.PDF (accessed 15 August 2005).
16. P. Tollman et al., A Revolution in R&D: How Genomics and Genetics Are Transforming the Biopharmaceutical Industry (Boston: Boston Consulting Group, 2001).
17. E.L. Eisenstein et al., "Reducing the Costs of Phase III Cardiovascular Clinical Trials," American Heart Journal 149, no. 3 (2005): 482-488.
18. E. Zerhouni, "Medicine: The NIH Roadmap," Science 302, no. 5642 (2003): 63-72.
19. Baum et al., "The Spontaneous Reporting System."
20. S. Okie, "Safety in Numbers - Monitoring Risk in Approved Drugs," New England Journal of Medicine 352, no. 12 (2005): 1173-1176.
21. J.A. Vernon, "Examining the Link between Price Regulation and Pharmaceutical R&D Investment," Health Economics 14, no. 1 (2005): 1-16;
22. T.A. Abbott and J.A. Vernon, "The Cost of U.S. Pharmaceutical Price Reductions: A Financial Simulation Model of R&D Decisions," NBER Working Paper no. 11114 (Cambridge, Mass.: National Bureau of Economic Research, 2 August 2005);
23. and F.M. Scherer, "The Link between Gross Profitability and Pharmaceutical R&D Spending," Health Affairs 20, no. 5 (2001): 216-220.
24. E.M. Vogt, "Effective Communication of Drug Safety Information to Patients and the Public: A New Look," Drug Safety 25, no. 5 (2002): 313-321.
25. J.W. Lee et al., "Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report," Pharmaceutical Research 22, no. 4 (2005): 499-511;
26. W. Lee et al., "Cancer Pharmacogenomics: Powerful Tools in Cancer Chemotherapy and Drug Development," Oncologist 10, no. 2 (2005): 104-111;
27. and A.D. Roses, "Pharmacogenetics and Drug Development: The Path to Safer and More Effective Drugs," Nature Reviews Genetics 5, no. 9 (2004): 645-656.