A short production interruption at a drug manufacturing plant is generally not something that will elicit a lot of publicity, but it is different when it involves a drug treatment for children during the flu season. And so the FDA let it be known Wednesday that there may be spot shortages of Tamiflu liquid because of manufacturing issues at a Genentech plant.
The FDA posted on its shortages website Monday that Genentech is experiencing temporary delays in manufacturing the oral suspension of Tamiflu and that a brief shortage is expected in early to mid-January. It said that capsule forms of the product remain available. The FDA said Genentech cited an increase in demand; however, healthcare professionals told the Philadelphia Inquirer that this has been a typical flu season. The Centers for Disease Control and Prevention (CDC) reports that case numbers remain below epidemic levels.
Tara Iannuccillo, a spokeswoman for Genentech, said in an email that "There has been strong and early demand for Tamiflu Oral Suspension (OS) and we are experiencing a temporary delay in the packaging of Tamiflu OS. A brief shortage of Tamiflu OS is expected through mid-January and as such, we may be unable to fill complete orders from distributors for a limited time. We expect to have additional supply of Tamiflu Oral Suspension in mid-January 2014."
Genentech, a division of Switzerland-based Roche ($RHHBY), warned the FDA a couple of days ago that it was having problems keeping up with demand for the liquid form of the product, Dr. Michael Jhung, a medical officer with the CDC's influenza division, told the Philadelphia Inquirer. He said the shortages will only be seen in some parts of the country and should only last about a week. He said the result may be that some children will be sicker longer. Jhung also said that a pharmacy can break open capsules and mix them into a liquid if it is needed. The FDA website has a link to instructions for healthcare providers on how to do that.
Roche has had to deal with shortages before, even suggesting there might be supply problems for its highly anticipated cancer drug Perjeta in 2012 just after it was approved by the FDA. It got that issue resolved quickly. At about the same time, the drugmaker ran into shortages of its osteoporosis drug Boniva because it had cut production in the expectation that sales of generic versions would reduce demand.
- here's where you can find the FDA announcement
- read the Philadelphia Inquirer story