Time to market for drugs approved in Canada between 2014 and 2018: an observational study

ObjectivesThis study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission (NDS) and compares Canadian and American times. Drugs approved between 1 January 2014 and 31 December 2018 are examined.DesignDescriptive study.Data sourcesWebsites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, WHO and previously published articles.InterventionsNone.Primary and secondary outcomesThe primary outcomes are time to market, time from patent application to NDS (pre-NDS time), review time, time from approval to availability (postapproval time) and factors that may influence the pre-NDS time. The secondary outcome is a comparison of Canadian and American review times and times between patent application and approval.ResultsThere were 113 drugs available for analysis. The median time to market was 11.80 years (IQR 9.40–14.05). The component median times were pre-NDS 10 years (IQR 8.05–12.80), review time 0.96 years (IQR 0.75–1.15) and postapproval time 0.15 years (IQR 0.08–0.28). Less than 8% of the pre-NDS time was explained by the factors that were analysed in a multiple linear regression equation. There was no statistically significant difference between Canadian and American pre-NDS times.ConclusionOnce a drug reaches the market, companies have a median of 8.2 years before the patent expires and generics can reach the market. Most of the time between the filing of a patent application and when a drug is marketed is determined by decisions that are largely under the control of the company.

The American Review of Public Administration: A Biography

This article is an intellectual history of the noble endeavors and challenges involved in the creation and evolution of the American Review of Public Administration. It traces the journal’s development from its beginning as the Midwest Review of Public Administration ( MRPA) under the leadership of Park College professor Jerzy Hauptmann, a Polish intellectual who entered the United States at the end of World War II. Hauptmann launched MRPA with a regional focus, welcoming contributions from a variety of voices in public service–related occupations. A political scientist suspicious of the power of national governments, Hauptmann favored a less top-down regional approach. The article provides insights from the late 1960s into the growing field of public administration. Behind the scenes, the article chronicles the financial challenges, details of manuscript review processes, and more in an initially low-technology world. This history is also multi-institutional, detailing the journal’s transfer from a small college to a team of scholars, including coauthor John Clayton Thomas, at the three public administration programs of the University of Missouri—in Columbia, Kansas City, and St. Louis. We are indebted to our now-departed colleague and coauthor, George Frederickson, for the idea of writing this article.

Declaration of Independence

This chapter examines Roth’s struggles with his father, his decision to go to college at Bucknell University after a year at Rutgers Newark, and his early girlfriends; the influence of his early professors at Bucknell and his editing the campus literary magazine where some of his earliest writing appeared. Graduate study at the University of Chicago and early publications followed, as well as his meeting influential novelists like Saul Bellow and Richard Stern. New friendships also emerged, notably with Theodore Solotaroff, critic and later editor of the New American Review, and Arthur Geffen and Barry Targan. “Bibliography by day, women by night” was their motto.

Revolutions and Insurrections: The North American Review and Haiti, 1821–1829

The New England based, conservative periodical North American Review published two reviews of Haiti, in 1821 and 1829. The reviews were starkly different in content and tone. This essay contextualizes the two reviews, using them as a mirror for the transformation of New England's political elite and its acceptance of the emerging racialist tenets of American nationalism. The essay thus sheds light on our understanding of antebellum nationalism and its nature.