Pharmaceutical and Medical Device Policy

Health policymakers have insufficiently addressed care for people with obesity (body mass index [BMI] ≥ 30 kg/m2) in the United States. Current… More

Virtually all modern medical devices now include embedded software, ranging from basic user interfaces and network connectivity to sophisticated… More

Our scoping review provides a roadmap of the questions being asked about the 340B program and an initial synthesis of the answers. More

Forty years ago, Congress enacted the Orphan Drug Act of 1983 (ODA), one of the most important and successful US laws to stimulate global life… More

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