key: cord-0793733-54pa2cye
authors: Tichy, Eric M.; Francis, James R.
title: Letter to the Editor - Impactful Policy Action to Reduce Drug Costs in Managing Critically Ill Patients with COVID19
date: 2020-06-30
journal: Mayo Clin Proc
DOI: 10.1016/j.mayocp.2020.06.042
sha: 632b03ebd01b99473a4a691b826d7db6a209eb7c
doc_id: 793733
cord_uid: 54pa2cye

nan

name drugs are used for COVID19 patients). One potentially highly impactful and easy to implement public policy solution we call attention to is the need to remedy unintended effects of the Drug Efficacy Study Implementation and Unapproved Drugs Initiative programs. These programs were implemented to provide review of drugs that have been available for decades and that had not completed formal FDA review. Because of these programs and abuses by manufacturers, dramatic escalation of cost and expense for certain older drugs that were once generic continue to occur. 3, 4 The most egregious example in the hospital sector over the past decade, is the dramatic rise in the cost of vasopressin, a drug that has been around for over 80 years and which is now among the top 25 drugs expenditures in hospitals as of 2019 and has patent protection until 2032. 5 Because of the high use of vasopressin in critically ill COVID19 patients and the greater than 6000% price increase that has occurred after completing the Unapproved Drugs Initiative process, vasopressin will likely become a top 10 drug expense within the hospital sector by the end of 2020. Inflation for vasopressin since undergoing approval through the Unapproved Drugs Initiative has been and continues to be dramatic. As result of COVID19, the manufacturer, Parr Pharmaceuticals, will experience further massive windfall profits and inflict billions of dollars of unreasonable costs for managing critically ill patients over the next decade.

Policy adjustments that addressing unintended consequences of the Drug Efficacy Study Implementation and Unapproved Drugs Initiative programs could prevent further economic harm related to vasopressin pricing and avoid similar abuses in the future.

Medication Shortages During the COVID-19 Crisis What We Must Do

Treatment Considerations for COVID-19: A Critical Review of the Evidence (or Lack Thereof)

The FDA Unapproved Drugs Initiative: an observational study of the consequences for drug prices and shortages in the United States

Estimating the impact of Food and Drug Administration's Unapproved Drug Initiative on drug prices and sales

National trends in prescription drug expenditures and projections for 2020

it is the journal's policy to invite the author(s) of the referenced article to publish a response. Drs Choo and Rajkumar were invited to respond, however, they were fully supportive of the letter by Tichy and Francis and did not feel a response was necessary