Trends: Are development times for pharmaceuticals increasing or decreasing?

Health Affairs

Volumn 25, Issue 2, 2006, Pages 461-468

  Keyhani, Salomon ^a   Diener West, Marie ^b   Powe, Neil ^c  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c Bloomberg School

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DRUG APPROVAL; DRUG COST; DRUG SCREENING; ECONOMICS; HUMAN; PRESCRIPTION; TIME; UNITED STATES;

CLINICAL TRIALS; DRUG APPROVAL; DRUG COSTS; DRUG EVALUATION; HUMANS; PRESCRIPTIONS, DRUG; TIME FACTORS; UNITED STATES;

EID: 33645653691     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.25.2.461     Document Type: Review

References (24)

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8. Pharmaceutical Research and Manufacturers of America, "Why Do Prescription Drugs Cost So Much...and Other Questions about Your Medicines," June 2000, http://www.phrma.org/publications/publications/ brochure/questions (accessed 31 August 2005);
9. and PhRMA, "The Search for a Cure for Cancer: New Medicines, New Hope," Summer 2003, http://www.phrma.org/publications/twopager/2003-06'24. 752.pdf (accessed 28 January 2005).
10. J.A. DiMasi, R.W. Hansen, and H.G. Grabowski, "The Price of Innovation: New Estimates of Drug Development Casts," Journal of Health Economics 22, no. 2 (2003): 151-185;
11. and J.A. DiMasi, "The Value of Improving the Productivity of the Drug Development Process: Faster Times and Better Decisions," PhamacoEconomics 20, no. 3 Supp. (2002): 1-10.
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14. S. Keyhani, M. Diener-West, and N. Powe, "Do Drug Prices Reflect Development Time and Government Investment?" Medical Care 43, no. 8 (2005): 753-762. This paper includes data on twelve additional antiretroviral drugs for which development data were obtained from sources other than the Federal Register. We chose to in clude data on antiretroviral drugs because the purpose of our previous study was to examine differences in prices between different drug classes after accounting for development time and other factors. Data on development time other than those available in the Federal Register are scarce; however, given interest in AIDS drugs early in the epidemic, data on these drugs were occasionally revealed by industry. We chose not to include these drugs in this study because they represent a highly select group that had rapid development and might have biased our data on development time downward.
15. The Federal Register (http://www.gpoaccess.gov/fr/advanced.html) can be searched to find notices related to patent term restoration.
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18. FDA, "Fast Track, Priority Review, and Accelerated Approval," 31 January 2006, http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm (accessed 31 January 2006).
19. FDA, "Frequently Asked Questions."
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21. and FDA, Dockets Management, http://www.fda.gov/ohrms/dockets (accessed 31 January 2006), for an actual application.
22. Lu and Comanor, "Strategic Pricing."
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24. and National Institute for Health Care Management Research and Educational Foundation, "Prescription Drugs and Intellectual Property Protection: Finding the Right Balance between Access and Innovation," August 2000, http://www.nihcm.org/prescription.pdf (accessed 12 January 2005).