Unbiased Analysis of Today's Healthcare Issues
That is the title of my recent piece in STAT News. Earlier this month, the Food and Drug Administration announced the creation of Project Facilitate. This pilot program facilitates access to innovative treatments for cancer that have not yet been approved by individuals who aren’t able to enroll in clinical trials. This move suggests that the…
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…
An interesting article in the N.Y. Times “Upshot” section by Austin Frakt argues that federal efforts to nudge people towards healthier behaviors may be doomed to fail. A $100 billion dollar health care package…encourages exercise by treating gym memberships as tax-deductible medical expenses…[a]nd it would permit the use of flexible spending accounts and health savings accounts…
Fung et al. (2019) conclude the following based on a 2017 survey of California residents: …19 percent reported that they would not have purchased insurance had there been no penalty. We estimated that premiums would increase by 4–7 percent if these enrollees were not in the risk pool. The percentages of enrollees who would forgo…
The 21st Century Cures Act, enacted December 2016, mandated that the FDA consider how to use real-world evidence (RWE) to bring innovative treatments to market faster. To meet this statutory requirement, the FDA has provided guidance outlining its policies for using RWE to support the approval of a new drug indication. What is real-world evidence?…
Darius Lakdawalla has an very interesting review article in the Journal of Economic Literature on the Economics of the pharmacuetical industry. Do read the whole thing, but below I have listed some highlights. A model of firm R&D decisions Lakdawalla uses a simple model based on Nordhaus (1969) to derive some important implications about pharmaceutical…
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…
An interesting article by Charles Silver and David A. Hyman argues that we should do away with patents for pharmaceuticals and move to a prize based system. They write in Vox: A well-designed prize regime would lower drug prices by eliminating drug monopolies, yet it would also create the necessary incentives for innovation, including incentives to…
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…