Enlli McAleese

Zambia approved a new HIV drug in just 12 days, far outpacing the average of 4-7 years in sub-Saharan Africa. How did they do it? Most countries spend years reviewing drug applications that have already been approved by the FDA or EMA. Zambia decided to do things differently, building a system that treated prior approvals from trusted agencies as a starting point. @EnlliMcA dives into Zambia’s process, and what we can learn from their experience:

There is no good reason for mosquitoes to exist in wealthy countries today. New technologies can get rid of the mosquito species that cause diseases like dengue, yellow fever, and malaria; and others can prevent them from carrying those diseases. worksinprogress.co/issue/mos… So why do mosquitoes still exist? In a new article for Works in Progress, Maya Rosen explains how state incapacity and risk aversion led to over a decade of delays and billions of unnecessary bites in the United States. Oxitec, for example, engineered an Aedes aegypti mosquito in such a way that its female offspring would die before adulthood. Through sustained releases, they showed they could reduce local mosquito populations by 80% or more, in field trials. They sought approval from the USDA in 2010, which then passed it to the FDA, which passed it to the EPA. In 2020, the EPA allowed them to conduct limited field trials in the Florida Keys. Two years ago, their experimental permit expired, and they still need another review before it can be used routinely. Their proposed field trial in California was withdrawn after public opposition. Another company, MosquitoMate, developed a technique involving Wolbachia, which also suppresses local mosquitoes. They then spent over fifteen years working through the system before finally receiving commercial registration nationwide in 2024. It seems that, sometimes, the barrier to getting rid of diseases isn’t technology at all. It’s policy and political will. New products shouldn’t get stuck in regulatory review for so long, especially if the delays are about basic questions like which agency has oversight over the product, rather than testing for safety. Though some of those uncertainties were being addressed, the broader changes haven’t materialized. After Biden’s 2022 executive order, the agencies planned to update how their coordinated framework was implemented. But Trump rescinded the order last year. Meanwhile, the EPA unit that reviews new mosquito control products is still a small office backlogged in reviewing a wide range of products. Mosquitoes are a policy choice. We can get rid of them. Will we choose to? worksinprogress.co/issue/mos…

Great to see the @AU_AMA_ in action as part of the Ebola outbreak response ema.europa.eu/en/news/ema-am…