How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.
Publication
, Journal Article
Reed, SD; Califf, RM; Schulman, KA
Published in: Health Aff (Millwood)
2006
Changes in the economics of product development resulting from heightened safety regulations could have a sizable negative impact on drug and biotechnology companies' decisions about investing in innovation. We developed a model to compare the potential economic effects of pre- and postmarketing strategies to identify safety problems with new drugs. Although expanding Phase III clinical testing and postmarketing safety surveillance are not perfect substitutes, our findings suggest that even a large increase in funding for the latter will have a relatively small adverse impact on investment decisions by drug companies and venture capital firms, compared with the former.
Duke Scholars
Published In
Health Aff (Millwood)
DOI
EISSN
2694-233X
Publication Date
2006
Volume
25
Issue
5
Start / End Page
1309 / 1317
Location
United States
Related Subject Headings
- United States Food and Drug Administration
- United States
- Safety
- Investments
- Humans
- Health Policy & Services
- Government Regulation
- Drug Industry
- Diffusion of Innovation
- Clinical Trials, Phase III as Topic
Citation
APA
Chicago
ICMJE
MLA
NLM
Reed, S. D., Califf, R. M., & Schulman, K. A. (2006). How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood), 25(5), 1309–1317. https://doi.org/10.1377/hlthaff.25.5.1309
Reed, Shelby D., Robert M. Califf, and Kevin A. Schulman. “How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.” Health Aff (Millwood) 25, no. 5 (2006): 1309–17. https://doi.org/10.1377/hlthaff.25.5.1309.
Reed SD, Califf RM, Schulman KA. How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood). 2006;25(5):1309–17.
Reed, Shelby D., et al. “How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.” Health Aff (Millwood), vol. 25, no. 5, 2006, pp. 1309–17. Pubmed, doi:10.1377/hlthaff.25.5.1309.
Reed SD, Califf RM, Schulman KA. How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health Aff (Millwood). 2006;25(5):1309–1317.
Published In
Health Aff (Millwood)
DOI
EISSN
2694-233X
Publication Date
2006
Volume
25
Issue
5
Start / End Page
1309 / 1317
Location
United States
Related Subject Headings
- United States Food and Drug Administration
- United States
- Safety
- Investments
- Humans
- Health Policy & Services
- Government Regulation
- Drug Industry
- Diffusion of Innovation
- Clinical Trials, Phase III as Topic