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.

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.

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.

The accreditation of public health departments is expected to play a significant role in strengthening the performance, effectiveness, and accountability of the nation’s public health system. After extensive study, a national voluntary accreditation program has been endorsed by leading public health organizations, including the American Public Health Association (APHA), Association of State and Territorial Health Officials (ASTHO), National Association of County and City Health Officials (NACCHO), and the National Association of Local Boards of Health (NALBOH).