Unbiased Analysis of Today's Healthcare Issues
Recently, the Food and Drug Administration (FDA) approved Prograf (tacrolimus) in combination with other immunosuppressant drugs for the new indication of preventing organ rejection for patients who have received a lung transplant. While the FDA approving a new indication isn’t typically news, this is a noteworthy event because (i) it marks the first approval of…
FDA draft guidance published this month says you should. In most cases, adjusting for covariates is not necessary. Randomization generally insurers that covariates are balanced across clinical trial arms. Randomization, however, may not always result in perfectly balanced trial arms. In these cases, the FDA notes that covariate adjustment is perfectly acceptable. There are some…
Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as new molecular entities (NMEs) under new drug applications (NDAs) or…
This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK recently has approved the Pfizer/BioNTech vaccine for COVID-19 before the US. Unlike most studies that attempt to examine the relationship between FDA review time and R&D investment dollars, the authors…
FDA faces an near existential crisis: digital. New digital technologies have the capability to improve the way care is delivered to patients. The question is, how do we make sure it is safe? The FDA is certainly good at making sure drugs and devices are safe; in the case of digital however, it is less…
The priority drug review process was enacted in 2012 in order to stimulate drug development for rare pediatric diseases. Drugs granted priority review had the typical ten-month FDA review timeline shortened to 6 months. For a drug to be eligible for this program, it must not only be for a rare disease but it must…
Many people think that once a treatment is approved, your insurance automatically covers the treatment. However, that is no longer the case. Some health plans may keep certain drugs off of formularies. Others health plans have drugs on formulary but may require step edits (failing another drug first before moving to the novel treatment) and…
The government strictly regulates what information that pharmaceutical firms can share with payers. There is good reason for this. We don’t want drug companies making false claims that a drug can treat/cure a disease when there is no evidence to support that claim. Randomized controlled trials are the gold standard of clinical evidence and studies…
Stereotypically, the U.S. health system is seen as one that is expensive and inefficient, but one where patients do get the fastest access to new innovation. However, does that prove true in reality? A paper by Zhang et al. (2017) attempts to answer this question by looking at 45 oncology drugs approved by the FDA…
The Economist has an article on the evolution of FDA regulation of pharmaceutical treatments. Brining a drug to market costs billions of dollars. FDA commissioner Scott Gottlieb aims to cut this cost by expediting the drug approval process in three key ways. First, he wants the agency to rethink how much information the FDA demands…