Pharmaceutical and Medical Device Policy

Prescription drug prices in the United States are substantially higher than in other high-income countries, with US prices reported to be an average of 2.78 times those of other countries in the Organisation for Economic Co-operation and Development.1 In response to these high prices, along with an opaque supply chain that can lead to substantial discrepancies in prices across different payors, states have passed drug price transparency laws that require manufacturers to disclose information on drug prices. More

Personalized medicine is one of those ideas that seems so obviously good it barely warrants debate. Why wouldn’t we want to tailor treatments to… More

The World Health Organization (WHO) Model Lists of Essential Medicines (EML) aims to help countries select medicines based on the priority needs of their populations. However, rapid evolution within the pharmaceutical sector toward complex, high-priced medicines has challenged WHO decision making, leading to inconsistent decisions. The purpose of this paper is to investigate how political factors impact the WHO EML. More

Addressing persistent and widespread challenges in any large organization necessitates implementation of policies and programs in ways that are… More

Cell and gene therapies (CGTs) offer treatment to rare and oftentimes deadly diseases. Because of their high price and uncertain clinical outcomes, US insurers commonly restrain patient access to CGTs, and these barriers may create or perpetuate existing disparities. A reconsideration of existing insurance policies to improve access and reduce disparities is currently underway. More

The Medicare drug negotiation framework established under the Inflation Reduction Act is far more limited than other frameworks in seven health systems explored in this study. More

The dangers of faulty laboratory tests have been highlighted recently because of reporting on the collapse of Theranos owing to fraudulent claims… More

Six decades after its creation, the Advisory Committee on Immunization Practices carries vastly expanded responsibilities, and its recommendations carry substantially greater impact. More

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

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