Incentives for orphan drug research and development in the United States

Background The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Methods Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. Results The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 ± 3.3 years (mean ± standard deviation). The average maximum effective patent and market exclusivity life was 11.7 ± 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Conclusion Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market

The Bio-Politics of Population Control and Sex Selective Abortion in China and India

China and India, two countries with skewed sex ratios in favor of males, have introduced a wide range of policies over the past few decades to prevent couples from deselecting daughters, including criminalizing sex-selective abortion through legal jurisdiction. This article aims to analyze how such policies are situated within the bio-politics of population control and how some of the outcomes reflect each government’s inadequacy in addressing the social dynamics around abortion decision making and the social, physical, and psychological effects on women’s wellbeing in the face of criminalization of sex-selective abortion. The analysis finds that overall, the criminalization of sex selection has not been successful in these two countries. Further, the broader economic, social, and cultural dynamics which produce bias against females must be a part of the strategy to combat sex selection, rather than a narrow criminalization of abortion which endangers women’s access to safe reproductive health services and their social, physical, and psychological wellbeing

Delivering medical abortion at scale: a study of the retail market for medical abortion in Madhya Pradesh, India.

BACKGROUND: Medical abortion (mifepristone and misoprostol) has the potential to contribute to reduced maternal mortality but little is known about the provision or quality of advice for medical abortion through the private retail sector. We examined the availability of medical abortion and the practices of pharmacists in India, where abortion has been legal since 1972. METHODS: We interviewed 591 pharmacists in 60 local markets in city, town and rural areas of Madhya Pradesh. One month later, we returned to 359 pharmacists with undercover patients who presented themselves unannounced as genuine customers seeking a medical abortion. RESULTS: Medical abortion was offered to undercover patients by 256 (71.3%) pharmacists and 24 different brands were identified. Two thirds (68.5%) of pharmacists stated that abortion was illegal in India. Only 106 (38.5%) pharmacists asked clients the timing of the last menstrual period and 38 (13.8%) requested to see a doctor's prescription - a legal requirement in India. Only 59 (21.5%) pharmacists correctly advised patients on the gestational limit for medical abortion, 97 (35.3%) provided correct information on how many and when to take the tablets in a combination pack, and 78 (28.4%) gave accurate advice on where to seek care in case of complications. Advice on post-abortion family planning was almost nonexistent. CONCLUSIONS: The retail market for medical abortion is extensive, but the quality of advice given to patients is poor. Although the contribution of medical abortion to women's health in India is poorly understood, there is an urgent need to improve the practices of pharmacists selling medical abortion

Domestic violence against women in eastern India: a population-based study on prevalence and related issues

<p>Abstract</p> <p>Background</p> <p>Violence against women is now widely recognised as an important public health problem, owing to its health consequences. Violence against women among many Indian communities on a regularly basis goes unreported. The objective of this study is to report the prevalence and other related issues of various forms of domestic violence against women from the eastern zone of India.</p> <p>Methods</p> <p>It is a population-based study covering both married women (n = 1718) and men (n = 1715) from three of the four states of Eastern India selected through a systematic multistage sampling strategy. Interviews were conducted using separate pre-piloted structured questionnaires for women (victimization) and men (perpetration). Women were asked whether their husband or any other family members committed violent acts against them. And men were asked whether they had ever perpetrated violent acts against their wives. Three principle domestic violence outcome variables (physical, psychological and sexual violence) were determined by response to a set of questions for each variable. In addition, data on socio-economic characteristics were collected. Descriptive statistics, bi- and multivariate analyses were done.</p> <p>Results</p> <p>The overall prevalence of physical, psychological, sexual and any form of violence among women of Eastern India were 16%, 52%, 25% and 56% respectively. These rates reported by men were 22%, 59%, 17% and 59.5% respectively. Men reported higher prevalence of all forms of violence apart from sexual violence. Husbands were mostly responsible for violence in majority of cases and some women reported the involvement of husbands' parents. It is found that various acts of violence were continuing among majority of women who reported violence. Some socio-economic characteristics of women have significant association with the occurrence of domestic violence. Urban residence, older age, lower education and lower family income are associated with occurrence of domestic violence. Multivariate logistic regressions revealed that the physical violence has significant association with state, residence (rural or urban), age and occupation of women, and monthly family income. Similar associations are found for psychological violence (with residence, age, education and occupation of the women and monthly family income) and sexual violence (with residence, age and educational level of women).</p> <p>Conclusion</p> <p>The prevalence of domestic violence in Eastern India is relatively high compared to majority of information available from India and confirms that domestic violence is a universal phenomenon. The primary healthcare institutions in India should institutionalise the routine screening and treatment for violence related injuries and trauma. Also, these results provide vital information to assess the situation to develop public health interventions, and to sensitise the concerned agencies to implement the laws related to violence against women.</p

De jure determinants of new firm formation: how the pillars of constitutions influence entrepreneurship

This paper provides empirical evidence supporting the view that constitutions are the primary and fundamental institutional determinant of entrepreneurship. It shows that some of the provisions contained in national constitutions are positively and significantly associated with a standard measure of entrepreneurial dynamics, namely the rate of new business density. Using for 115 countries a novel dataset containing the characteristics of the constitutions enacted in the world, applying an IV-GMM treatment to deal with the endogeneity of constitutional rules, and controlling for de facto variables, the paper finds that provisions about the right to conduct/establish a business, the right to strike, consumer protection, anti-corruption, and compulsory education promote higher rates of new firm formation. Contrasting results are instead obtained for provisions concerning protection of intellectual property rights