Presto! Tamiflu multiplies in supply chain magic

Regulatory sleight of hand is increasing supplies of Tamiflu. As reported earlier, Pharmacists are boosting dwindling stores of liquid Tamiflu for children by compounding the contents of expired tablets with cherry syrup. And With the CDC's blessing, some states are receiving the out-of-date solid oral dosage form, which the FDA says is safe and effective, to augment on-hand supplies.

Actual science is behind the prestidigitation. Under the federal Shelf-Life Extension Program, which covers stockpiled antivirals including Tamiflu and Relenza, the FDA tests and analyzes specific lots of the expired medication. If the product passes, FDA extends the shelf life beyond its expiration date. Such testing is permitted under Emergency Use Authorization rules, which permit the waiving of storage requirements for drugs in public health stockpiles.

Some 26 lots of Tamiflu for oral suspension have passed the FDA tests. Products having original expiration dates as long ago as January 31, 2006, have been pushed out to August 31, 2010 for compounding.

The shortage of new supplies of the liquid drug shortage is the result of Roche shifting production to tablets to keep up with world demand--the same production capacity needed to produce a liquid treatment for one person can be used to make capsules for ten.

- see the FDA information on expiring antiviral stockpiles
- read the report on on a Texas shipment
- here's an article on the compounding effort

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.