Ethanol locks are now going to be ridiculously expensive (possibly $30,000 per month -for 1 oz) due to an FDA initiative which aims to improve drug safety. Paradoxically, this could endanger the health of many vulnerable children.

Modern Healthcare: Unapproved Drug Initiative adds up to $30 billion in healthcare costs Thanks to Jennifer Sterner-Allison for this reference.

An excerpt:

A regulatory pathway that aims to ensure drug safety is inflating healthcare spending by billions of dollars, according to a new report.

Four widely used drugs funneled through the Unapproved Drug Initiative will increase spending by more than $20.25 billion over a five-year span as manufacturers hiked prices between 525% to 1,644%…

“Hospitals are absorbing additional cost for drugs that are not innovative, not curing new diseases, do not have overwhelming R&D investment, and are often the preferred drug of choice.”…

The 2006 Unapproved Drug Initiative requires manufacturers to pull these drugs and prove to the FDA that they are safe. Typically, fewer manufacturers remain in the market after the FDA intervenes, which allows price manipulation.

Drugs that go through the UDI pathway can earn the manufacturer up to seven years of patent protection, which can prevent competition. At minimum, other suppliers of the drug targeted by the UDI also have to leave the market and receive approval, which can reduce competition.

The situation with ethanol is particularly egregious, said Erin Fox, a drug shortage expert and senior director of drug information and support services at University of Utah Health.

Belcher Pharmaceuticals is charging $1,000 per milliliter, which equates to $30,000 for one shot of ethanol, since it received an orphan drug designation through the UDI, granting Belcher’s drug exclusivity through 2025, she said. Belcher won the orphan drug classification, a status for drugs that treat rare diseases, for its treatment of hypertrophic obstructive cardiomyopathy.

“It is the perfect example of how this FDA approval process is broken,” Fox said. “Pediatric hospitals are going to be particularly impacted because ethanol is sometimes used to ‘lock’ IV ports to prevent infections in high-risk patients.”..

“FDA’s Unapproved Drug Initiative continues to have serious unintended consequences and in my opinion should be halted,” she said

My take: I have contacted the American Academy of Pediatrics and asked them to try to work on this problem.  The high cost of ethanol may prevent its routine use and result in central line infections, hospitalizations and even death in vulnerable children.

Related blog posts (on utility of Ethanol Locks):

• One More Way to Prevent CVL Infections | gutsandgrowth
• Ethanol locks -jump on the bandwagon | gutsandgrowth
• More on ethanol locks | gutsandgrowth
• Four advances for intestinal failure | gutsandgrowth
• Another option for line locks | gutsandgrowth
• Rehabilitation for Short Bowel Syndrome | gutsandgrowth
• IFfy outcome | gutsandgrowth

Blogs related to Pharmaceutical Practices:

• 5000% Increase for Well-Established Drug
• Public Shaming is Not an Effective Drug Pricing Policy | gutsandgrowth
• Orphan Drugs –Very Profitable | gutsandgrowth
• Another Shady Pharmaceutical Business Practice: Citizen’s Pathway to Delay Competition | gutsandgrowth
• Orphan Drugs –Very Profitable | gutsandgrowth
• How to Undermine Value Care: Lessons from Pharmaceuticals | gutsandgrowth
• Legislative Agenda for Drug Pricing

Ethanol locks can minimize infections among patients who receive intravenous nutrition (“TPN”) which was popularized by Dr. Dudrick.  Due to the exorbitant costs of ethanol, this may lead to increased infections, hospitalizations and even death.