The mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion.
To estimate the research and development investment required to ...bring a new therapeutic agent to market, using publicly available data.
Data were analyzed on new therapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estimate the research and development expenditure required to bring a new medicine to market. Data were accessed from the US Securities and Exchange Commission, Drugs@FDA database, and ClinicalTrials.gov, alongside published data on clinical trial success rates.
Conduct of preclinical and clinical studies of new therapeutic agents.
Median and mean research and development spending on new therapeutic agents approved by the FDA, capitalized at a real cost of capital rate (the required rate of return for an investor) of 10.5% per year, with bootstrapped CIs. All amounts were reported in 2018 US dollars.
The FDA approved 355 new drugs and biologics over the study period. Research and development expenditures were available for 63 (18%) products, developed by 47 different companies. After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $985.3 million (95% CI, $683.6 million-$1228.9 million), and the mean investment was estimated at $1335.9 million (95% CI, $1042.5 million-$1637.5 million) in the base case analysis. Median estimates by therapeutic area (for areas with ≥5 drugs) ranged from $765.9 million (95% CI, $323.0 million-$1473.5 million) for nervous system agents to $2771.6 million (95% CI, $2051.8 million-$5366.2 million) for antineoplastic and immunomodulating agents. Data were mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. Results varied in sensitivity analyses using different estimates of clinical trial success rates, preclinical expenditures, and cost of capital.
This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data. Differences from previous studies may reflect the spectrum of products analyzed, the restricted availability of data in the public domain, and differences in underlying assumptions in the cost calculations.
This paper investigates the relation between growth forecast errors and planned fiscal consolidation during the crisis. We find that, in advanced economies, stronger planned fiscal consolidation has ...been associated with lower growth than expected. The relation is particularly strong, both statistically and economically, early in the crisis. A natural interpretation is that fiscal multipliers were substantially higher than implicitly assumed by forecasters. The weaker relation in more recent years may in part reflect learning by forecasters and in part smaller multipliers than in the early years of the crisis. PUBLICATION ABSTRACT
Government efforts to lower drug costs and other legislative and regulatory initiatives may be counteracted by campaign donors and lobbyists in the pharmaceutical and health product industry.
To ...review how much money the pharmaceutical and health product industry spent on campaign contributions and lobbying in the US from 1999 to 2018 at the federal and state levels.
Analysis of federal-level and state-level data obtained from the Center for Responsive Politics and the National Institute on Money in Politics, respectively. These nonprofit, nonpartisan organizations track federal and state campaign contributions and lobbying expenditures by individuals and groups.
Lobbying expenditures and contributions to political campaigns.
Total spending, inflation adjusted to 2018 dollars using the US Consumer Price Index, on lobbying and campaign contributions by year, source, and state.
From 1999 to 2018, the pharmaceutical and health product industry recorded $4.7 billion-an average of $233 million per year-in lobbying expenditures at the federal level, more than any other industry. Of the spending, the trade group Pharmaceutical Research and Manufacturers of America accounted for $422 million (9.0%), and the other 19 top companies and organizations in this industry accounted for $2.2 billion (46.8%). The industry spent $414 million on contributions to candidates in presidential and congressional elections, national party committees, and outside spending groups. Of this amount, $22 million went to presidential candidates and $214 million went to congressional candidates. Of the 20 senators and 20 representatives who received the most contributions, 39 belonged to committees with jurisdiction over health-related legislative matters, 24 of them in senior positions. The industry contributed $877 million to state candidates and committees, of which $399 million (45.5%) went to recipients in California and $287 million (32.7%) went to recipients in 9 other states. In years in which key state referenda on reforms in drug pricing and regulation were being voted on, there were large spikes in contributions to groups that opposed or supported the reforms.
From 1999 to 2018, the pharmaceutical and health product industry spent large sums of money on lobbying and campaign contributions to influence legislative and election outcomes. These findings can inform discussions about how to temper the influence of industry on US health policy.
The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have ...authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities. In this Health Policy paper, we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review, we developed a dashboard to highlight key characteristics of 26 leading vaccine candidates, including efficacy levels, dosing regimens, storage requirements, prices, production capacities in 2021, and stocks reserved for low-income and middle-income countries. We use a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity, highlighting important trade-offs that policy makers need to consider when developing and implementing vaccination programmes. Although specific datapoints are subject to change as the pandemic response progresses, the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. We also present original data from a 32-country survey (n=26 758) on potential acceptance of COVID-19 vaccines, conducted from October to December, 2020. Vaccine acceptance was highest in Vietnam (98%), India (91%), China (91%), Denmark (87%), and South Korea (87%), and lowest in Serbia (38%), Croatia (41%), France (44%), Lebanon (44%), and Paraguay (51%).
This synthesis discusses the emissions of carbon dioxide from fossil-fuel combustion and cement production. While much is known about these emissions, there is still much that is unknown about the ...details surrounding these emissions. This synthesis explores our knowledge of these emissions in terms of why there is concern about them; how they are calculated; the major global efforts on inventorying them; their global, regional, and national totals at different spatial and temporal scales; how they are distributed on global grids (i.e., maps); how they are transported in models; and the uncertainties associated with these different aspects of the emissions. The magnitude of emissions from the combustion of fossil fuels has been almost continuously increasing with time since fossil fuels were first used by humans. Despite events in some nations specifically designed to reduce emissions, or which have had emissions reduction as a byproduct of other events, global total emissions continue their general increase with time. Global total fossil-fuel carbon dioxide emissions are known to within 10 % uncertainty (95 % confidence interval). Uncertainty on individual national total fossil-fuel carbon dioxide emissions range from a few percent to more than 50 %. This manuscript concludes that carbon dioxide emissions from fossil-fuel combustion continue to increase with time and that while much is known about the overall characteristics of these emissions, much is still to be learned about the detailed characteristics of these emissions.
Significant augmentation of second harmonic generation using Fano resonances in plasmonic heptamers made of silver is theoretically and experimentally demonstrated. The geometry is engineered to ...simultaneously produce a Fano resonance at the fundamental wavelength, resulting in a strong localization of the fundamental field close to the system, and a higher order scattering peak at the second harmonic wavelength. These results illustrate the versatility of Fano resonant structures to engineer specific optical responses both in the linear and nonlinear regimes thus paving the way for future investigations on the role of dark modes in nonlinear and quantum optics.
The optical properties of plasmonic nanostructures supporting Fano resonances are investigated with an electromagnetic theory. Contrary to the original work of Fano, this theory includes losses in ...the materials composing the system. As a result, a more general formula is obtained for the response of the system and general conclusions for the determination of the resonance parameters are drawn. These predictions are verified with surface integral numerical calculations in a broad variety of plasmonic nanostructures including dolmens, oligomers, and gratings. This work presents a robust and consistent analysis of plasmonic Fano resonances and enables the control of their line shape based on Maxwell’s equations. The insights into the physical understanding of Fano resonances gained this way will be of great interest for the design of plasmonic systems with specific spectral responses for applications such as sensing and optical metamaterials.
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