FDA New Drug Approval Times, Prescription Drug User Fees, and R & D Spending

FDA-approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical R&D have likely increased. In the current paper we employ a unique survey dataset, which includes for the first time data on firm-level pharmaceutical R&D. We estimate the effects that FDA-approval times have on R&D investments. Controlling for other factors such as pharmaceutical profitability and cash flows, we find that a 10 percent decrease (increase) in FDA-approval times results in a 1.7 percent in increase (decrease) in R&D spending.Combining this estimate with previous research and publicly available data on industry-level pharmaceutical spending between 1992 and 2001, we conclude PDUFA, and its subsequent renewals, stimulated an additional 13.5 billion in pharmaceutical R&D (2005 U.S.), and has presumably continued to do so since 2001. Recent economic research has shown the social rate of return on pharmaceutical R&D is remarkably high; thus, the social benefits of PDUFA (over and above the benefits of more rapid consumer access) are likely to be substantial.

Utah’s Watershed Restoration Initiative: Restoring Watersheds at a Landscape Scale

Abstract: The Utah Watershed Restoration Initiative (WRI) is a partnership-based program, administered by the Utah Department of Natural Resources, which seeks to improve the functional capacity of high priority watersheds throughout the state. Since its inception in 2006, the WRI partnership has completed nearly 1,500 projects to restore and rehabilitate over 526,091 ha in Utah watersheds. The WRI program is unique to the west, in that it transcends jurisdictional boundaries, and local, state, and federal management authority to focus finite resources on completing high priority conservation projects. We surveyed selected WRI selected participants in 2015 to determine what factors they believed most contributed to the overall success of the program. Survey respondents attributed the success of the WRI program to: 1) engaged leadership at multiple levels, 2) a bottom-up hierarchy, 3) a history of collaboration, 4) practice partnerships, 5) a science-based approach, 6) operating at a meaningful spatial scale, 7) being solution minded, not problem focused, and 8) unselfish sharing of resources. In this paper we discuss these success factors and provide recommendations to those desiring to implement voluntary incentive-based landscape conservation strategies

Removal of radioactive fission products from surface water supplies

Also available online.Digitized 2007 AES

An Investigation of Combined Thermal Weakening and Mechanical Disintegration of Hard Rock

The research under modified Contract No. H0220068 has been devoted to experimental thermal-mechanical fragmentation of Missouri red granite in place, and to supporting theoretical analyses. The results of the previous year\u27s experimental work showed that thermal stresses are several times more effective in fragmenting hard rock when they are created within the rock rather than upon the surface. Also, large blocks {4-foot cubes) are not adequate to simulate the response of in situ rock. Based upon laboratory tests an experimental round was designed analogous to an explosive blasting round with coiled wire heating elements placed in drill holes. Three displacement relief faces were required for effective fracture at a 5 kw power level for a 10 inch burden. However, the heaters clogged and failed, and although the rock was effectively fractured, the fragments required considerable mechanical effort to remove them. Electric arcs at 12 kw, utilizing carbon electrodes were employed to create thermal inclusions, and in holes 14 inches in depth with equal burden. The rock was fractured and easily removed, as was also the case with 20 inches depth and overburden. Experiments are in progress to optimize round geometry and energy levels. Major problems are the brittleness of the carbon electrodes and maintaining of a stable arc as the heating is begun. Both of these problems are being solved. Theoretical analyses of temperature and thermal stress distribution are progressing well and procedures are being refined for use of more accurate boundary conditions, temperature-dependent rock properties, and other input parameters. Laboratory experiments are being conducted to determine stress and temperature distribution for a cylindrical geometry for basalt. Calculations of projected rates of advance and excavation costs indicate that for a slot type round the process is technically and economically feasible. --Summary, page 1a

Combined Thermal Weakening and Mechanical Disintegration of Hard Rock

This investigation of the combined effects of thermal weakening and mechanical disintegration (thermomechanical fragmentation) was initiated with a view toward better understanding of the processes required for more rapidly and economically fragmenting or excavating hard rock. Boring machines for utility tunnels, transportation tunnels or mining operations may be able to utilize the advantages of processes such as thermomechanical fragmentation. Secondary fragmentation or rock crushing processes also can conceivably employ the data obtained from this study