Drug Importation and its Deleterious Effects on the U.S. Pharmaceutical R&D Industry. Jeannie Chow 30 November 2004 Pharmaceutical Regulatory Affairs. Agenda. Background Will Drug Importation Work? FDA’s Rules & Regulations Financial/R&D Effect of Drug Importation
30 November 2004
Pharmaceutical Regulatory Affairs
Source: IMS Health Data. Anderson, Gerard F., “Doughnut Holes and Price Controls”. Health Affairs. 21July2004.
Congressional Budget Offfic, H.R. 2427: The Pharmaceutical Market Access Act of 2003, CBO Cost Estimate (November 2003)
“The Future of Price Regulation in the U.S. Pharmaceutical Market,” The Cambridge Briefing. September 2004.
Source: EFPIA member associations, PhRMA, JPMA. 2003 U.S figure is an estimate. 2003 Japan figure not available.
Source: SCRIP-EFPIA calculation (according to nationality of mother company).
Source: EFPIA member associations.
Source: Tuerck, D.G., Barrett, J., Giuffre, D., and Rzakhanov, Z. “The Impact of Drug Reimportation and Price Controls: The U.S and Massachusetts.” Institute for Policy Innovation. Policy Report 184. September 2004.
Source: Reinhardt, U.E., “U.S Health Care Spending In An International Context”, Health Affairs 23(3): 10-25. May/June 2004
Lack of FDA’s Ability to Assure Safety
Patent Rights Jeopardized
Significant FDA Administrative Resource Costs
Decreases R&D spending/No. of New Drugs
Lacks Drug Safety
Would not reduce U.S. prescription drug spending
Direct to Consumer AdvertisingRecommendation/Approach to the Possibility of Drug Importation