Pharmaceutical and Medical Device Policy

Although it will not fully solve patent barriers to the access of medicines, implementation of compulsory licensing (and specifically those for the import and export of pharmaceutical products) will provide governments with another tool to safeguard their population’s public health. More

Context: The Food and Drug Administration (FDA)’s accelerated-approval pathway expedites patient access to promising treatments. However,… More

Since before Ponce de Leon’s quest for the fountain of youth that led him to discover what is now Florida and Cervantes’ Don Quixote’s likeminded search, humans have sought a way to slow or even reverse the aging process. Now, however, we have preliminary evidence that there are indeed methods of slowing down senescence. More

Ideally, medical care is based on diagnostics and treatments for health conditions that have evidence that their benefits outweigh any potential… More

This study finds that newly approved drugs are frequently subject to formulary exclusions and restrictions such as prior authorization in Medicare Part D plans. More

In 1993, Stephen Soumerai and coauthors published “A Critical Analysis of Studies of State Drug Reimbursement Policies: Research in Need of… More

This study by Lindor Qunaj of Montefiore Medical Center and colleagues finds that compulsory licensing, a practice whereby national authorities can enable the production of a generic before the original patent expires, is rarely used to address drug prices and, when used, is unlikely to contribute to price discounts. More

Context: Rising prescription drug costs are consuming a growing proportion of state and private budgets. In response, lawmakers have experimented with… More

Context: The image of generic drugs as a commodity sold in competitive markets is an oversimplification, as evidenced by increasing accounts of price… More

After more than a decade of promise and hype, artificial intelligence (AI) and machine learning (ML) are finally making inroads into clinical… More