Do firms leverage the FDA nutrient label rounding rules to generate favorable nutrition fact panels or health claims?

The increasing incidence of nutrition related health concerns has made food labeling an important policy issue. Previous work suggests the importance of communicating nutrition information to consumers through product packaging. This paper investigates the role of labeling guidelines, which allow the rounding of calorie and nutrient levels on nutrition fact panels and affects front of package claims. We examine ready-to-eat cereal products as a bundle of nutrient attributes, and estimate the likelihood and magnitude of the rounding of specific nutrients and calories. We find systematic rounding, both up and down, of several nutrients, which affects allowable health claims and may influence consumer product choice and health outcomes.     

Efficiency and its determinants in pharmaceutical industries: ownership,R&D and scale economy

The purpose of this article is to measure the efficiency of pharmaceutical firms and identify their determinants using Korean and American samples from 1992 to 2004. We document some stylized facts in the patterns and sources of efficiency change in Korean and American pharmaceutical firms. The evidence shows that ownership structure can substantially influence the efficiency of pharmaceutical firms. Especially, institutional ownership rate affects corporate efficiencies negatively, corroborating the myopic institutional investor hypothesis. The hypothesis is supported by both Korean and American samples. However, we find evidence that foreign ownership in Korea promotes efficiency of pharmaceutical firms. It is shown that R&D intensity is positively related to contemporaneous largest ownership rate and prior foreign ownership rate in Korean pharmaceutical firms. In contrast, little evidence is found on the relationship between ownership structure and R&D intensity in the American pharmaceutical industry. These empirical results are robust even after we check the causal links among efficiency, R&D and ownership.     

中国原料药国际注册现状

中国是世界原料药生产大国,中国的药品要走向世界,必须进行国际注册,这对原料药生产企业来说具有非常重要的现实意义。对中国原料药国际注册的现状进行了综述,简要介绍了美国FDA认证、欧盟CEP认证情况,并同印度原料药国际注册现状进行了比较。     

FDA的关键路径计划

"关键路径计划"是美国食品药品监督管理局于2004年3月推出的旨在加快新医疗产品研发进度、使当代生物医学基础研究所取得的重大成果能迅速应用于改善人类健康的一项全国性的工程.在实施该计划的3年时间里,虽然新药研发产出普遍不足的问题尚未得到彻底改观,但不容置疑的是该计划的实施对于医药企业的新产品研发过程及FDA的审批机制产生了深远的影响,并达到了部分预期的目标.     

Evaluating Wisconsin dairy producer compliance and potential eligibility for international markets under existing European Union and United States Grade “A” bulk tank somatic cell count compliance criteria

A proposal to lower the bulk tank Somatic Cell Count (SCC) maximum for United States of America (US) Grade “A” milk producers was not adopted by the National Conference on Interstate Milk Shipments in 2011 or 2013. The proposal would have made the US Grade “A” limit consistent with many other international standards, including that of the European Union (EU). Some US states, however, have proactively adopted their own SCC limit to mirror the EU limit. The purpose of this study was to analyze the impacts on Wisconsin dairy producers if Wisconsin should adopt the current EU limit and compliance criterion. Analyses were done on SCC results for Wisconsin Grade “A” and Grade “B” dairy producers reported each month to the Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) during January 1, 2009–December 31, 2012. Results were evaluated against the current US Grade “A” and EU compliance criteria for SCC and the percentage of (producer × month) combinations in compliance was determined. If the current EU SCC compliance criterion was in place, 86.7–94.3 and 64.3–77.3% of Wisconsin Grade “A” and “Grade “B” (producer × month) combinations, respectively, would have been in compliance for the years 2009–2012. Compliance of Wisconsin Grade “A” and Grade “B” producers with the existing US SCC compliance criterion during the same period was 99.3–99.7% and 87.9–93.9% (producer × month combinations) respectively. An analysis of a subset of Wisconsin Grade “A” producers indicated that smaller-volume producers were less likely than larger-volume producers to meet the EU criterion.     

Health claims and consumers’ behavioral intentions: The case of soy-based food

This research evaluates the impact of two soy-specific health claims (highlighting FDA approval along with scientific results and simply describing scientific results) on stated behavioral intentions toward soy-based food using a survey administered by Ipsos-Observer to a nationally representative web panel in the summer of 2007. Our research design randomly assigned respondents to a health claim. Three ordered probit models (non-soy users; infrequent soy users; regular soy users) show that non-soy users and infrequent soy users who were exposed to either FDA health claim or general health claim are significantly more likely to eat soy-based food products. FDA or general health claim, however, did not change the behavioral intentions of regular soy users. These results suggest that soy consumption status moderates the impacts of health claims on behavioral intentions. However, the impact of FDA health claim did not differ from that of general health claim, indicating that the word ‘FDA’ did not add any additional information to consumers beyond the general health claim.     

美国植物药临床试验上市申请及审批

近年来,越来越多的中草药开始逐渐地尝试进入美国主流市场.许多中草药类药品已经进入临床Ⅰ、Ⅱ、Ⅲ期试验,尤为可喜的是第一个中草药类药品绿茶茶多酚,成功的通过了美国食品药品监督管理局(FDA)的新药审批.这一划时代的第一个中草药类药品在美国上市,为中国的药品尤其是中国中草药类药品进入美国主流市场打开了一扇大门.也为我们广大的中国企业为中草药类药品进入美国主流市场提供了一个极好的学习样例.     

Two faces of corporate lobbying: Evidence from the pharmaceutical industry

In this study, we examine how political connections increase firms’ innovation performance. By examining firm-level lobbying activities, we find that political connections lead to a greater number of medical breakthroughs among pharmaceutical firms in our sample. We then examine the underlying ways that political connections enhance innovation among medical firms. Using hand-collected data on government subsidies, we find that politically connected firms have a higher chance of receiving subsidies from federal, state, or local government agencies. These government subsidies enhance medical innovation by insulating managers from short-term threats and mitigate their career concerns by creating a “failure tolerant” environment. Overall, we show that connections between firms and politicians come with increased innovation outcomes.     

Valuation implications of pharmaceutical companies' R&D regulatory approval notifications

This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges. Applications to the FDA for drug approvals significantly increase shareholder wealth for NYSE firms only. The increase is driven by applications for enhancements to existing drugs, with the market anticipating the application, thus suggesting information leakage. FDA approvals also significantly increase shareholder wealth in both markets. However, there is no evidence of information leakage and the significant post-event abnormal returns support the attention-grabbing hypothesis. Enhanced drug approvals are value-relevant for both markets, which highlights the contribution of real-options to firm value.