Unbiased Analysis of Today's Healthcare Issues
In July 2018, FDA released the Biosimilars Action Plan (BAP), which outlined FDA’s approach for expanding access to biosimilars for the American public. The plan focused on 4 key areas: A recent FDA report reviews some of their accomplishments since then. Most of these efforts revolve around guidance documents, additional staff, education products and websites,…
According to the 2019 NSDUH survey, 27.7 percent of 18-22 year olds who are not enrolled in college full-time and 33.0% of 18-22 year old full-time college students reported binge drinking in the past month. Should society impose stricter restrictions on drugs and alcohol for younger individuals? On the one hand, drugs and alcohol harm…
For patients with serious illnesses, timeline access to efficacious medications is paramount. The European Medicines Agency (EMA) was created in part to help expedite drug approvals and insure these products are save and effective. As stated in a paper by Grünwald and Stargardt (2024): The EMA [European Medicines Agency] was founded in 1995 primarily to…
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…
Last week, FDA authorized the State of Florida to import pharmaceuticals from Canada. The price of branded pharmaceuticals in the US is nearly three times the cost of identical pharmaceuticals in Canada, so this approach could save the US money. While there are some administrative issues to work out on the US side, the biggest…
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…
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…
Last month, FDA released guidance on the use of real-world evidence to support regulatory decision-making for new drugs. Below are some of the key points from this guidance document: Legislative mandate. The 21st Century Cures Act (Cures Act), signed December 2016, mandated that the FDA consider how to incorporate real world data (RWD) into regulator…
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…
That is the title of a very interesting paper by Casey Mulligan (2023) [NBER WP version]. The full title includes the phrase “Peltzman revisited”. This refers to a paper by Peltzman (1973).When speaking of the 1962 “Drug Efficacy Amendment” (EA) to the Federal Food, Drug, and Cosmetic Act a key piece of research was Peltzman…