Changes to the FDA Advisory Committee process

It appears changes are coming to the FDA Advisory Committee process for evaluating new drugs. The FDA is planning significant reforms to its advisory committee process, as announced by Commissioner Rob Califf. While specifics are scarce, these changes are spearheaded by Namandjé Bumpus, the FDA’s chief scientist, and newly appointed deputy commissioner.Califf noted improvements in…

How do different countries negotiate drug prices?

This question is particularly relevant with the passage of the Inflation Reduction Act (IRA) and the requirement that CMS negotiate a ‘maximum fair price’ for drugs with the biggest impact on Medicare’s bottom line. A Health Affairs Forefront paper by Lin et al. (2023) compares how drug price negotiation differs between Canada, France, Germany and…

Does the 340B program improve quality of care?

According to a paper by Smith et al. 2023, the answer is ‘no’. The authors use data from AHRQ’s Healthcare Cost and Utilization Project (HCUP) State Inpatient Data, Hospital Cost Reporting Information System Data, Office of Pharmacy Affairs Information System Data, and American Hospital Association Annual Survey for 15 states between 2008 to 2014. The…

European Union Pharmaceutical Package: A Summary

Today I’m turning this post over to some of my FTI colleagues in Europe (Antoine Mialhe, Katja Murray and Valeria Fagone among others) who helped summarize the Reform of the EU pharmaceutical legislation that the European Union (EU) adopted on April 26, 2023. The summary below is provided by the FTI Consulting team in Brussels…

FDA’s 2022 Drug Approvals

The year 2022 was a good, but perhaps not great year for innovation. According to the FDA’s Center for Drug Evaluation and Research’s (CDER) New Drug Therapy Approvals 2022 report, there were 37 novel drugs approved in 2022. This number is down from the historical rate of approvals between 2013-2021 (43.4 approvals per year) and…