The Hatch-Waxman Act regulates competition between brand-name and generic drugs in the United States. This study examines a feature of the Act that has attracted great controversy but little systematic attention. “Paragraph IV” challenges are a mechanism for generic drug makers to challenge the patents of brand-name drug makers as a means to secure early market entry. The study first presents descriptive results that chart the rise of brand-name patent portfolios and Paragraph IV challenges.
Observers worry that generic patent challenges are on the rise and reduce the effective market life of drugs. A related concern is that challenges disproportionately target high-sales drugs, reducing market life for these “blockbusters.” To study these questions, this study examines new data on generic entry over the past decade. The results show that challenges are more common for higher sales drugs. The study also demonstrates a slight increase in challenges over this period, and a sharper increase for early challenges.
University of Pittsburgh Graduate School of Public Health, Center for Public Health Practice
Overall annual influenza vaccination rate has slowly increased among health care workers but still remains below the national goal of 90 percent. One hundred fifty hospitals required influenza vaccination, 84 with consequences (wear a mask, termination, education, restriction from patient care duties, unpaid leave) and 66 without consequences for noncompliance. Hospitals whose mandates have consequences for noncompliance included a broader range of personnel, were less likely to allow personal belief exemptions, or to require formal declination.
The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. This study reviews a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics.
Parental involvement (PI) laws require that physicians notify or obtain consent from a parent(s) of a minor seeking an abortion before performing the procedure. This study shows that prior evidence based on gonorrhea rates overlooked the frequent under-reporting of gonorrhea by race and ethnicity, and presents new evidence on the effects of PI laws using more current data on the prevalence of gonorrhea and data that are novel to this literature (i.e., chlamydia rates and data disaggregated by year of age).
This letter to the editor of Clinical Infectious Diseases explores the "10 x ′20 initiative" — a global commitment to develop 10 new antimicrobials by 2020. The authors question the development costs, the current clinical trial system, and the neglection of current antimicrobials. They also examine issue of quality versus quantity and conclude that "... we need to set priorities to achieve a balance between antibiotic conservation and new drug development, focusing on policies that will best serve public health.
University of Washington, Office of Sponsored Programs
In this article for the Archives of Pediatrics and Adolescent Medicine (now JAMA Pediatrics), the author discusses two articles, by McCabe, et al. and Meier et al., but also raises two questions about the issues of opioid abuse and adolescents. He asks, "What is the role of parents and what is the role of the prescriber, and others, in educating parents about the potential hazards of opioids, the relative need for them, how to safeguard them at home, and the need to dispose of unused medications immediately?"
The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. This paper reviews a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics.
Americans today have difficulty accessing primary care. Nurse practitioners could supplement the care provided by general practitioner physicians, and remove a barrier to care that would improve health outcomes and save money, explains Jamie Ware, JD, MSW, in her Critical Opportunities presentation.
Public Health Management Corporation/National Nurse-Led Care Consortium
This LawAtlas map shows state statutes and regulations that address health departments’ ability to release and use personally identifiable information for communicable disease cases to promote public health and coordinate care.