NEW WARNING ADDED TO TEPEZZA LABEL

The makers of Teppeza have added two new sections to their warning label “Hearing Impairment Including hearing loss” and “severe hearing impairment hearing loss, cases may be permanent”. (see link below).

Attorney Michael Brady Lunch, who has been involved in the Tepezza hearing loss litigation will give attendees of our September 22nd - 24th litigation updates the information they need to get involved in this litigation. Given the new warnings added to the product label, you will not want to miss Michael’s presentation.

Book your room today: http://bookings.ihotelier.com/bookings.jsp?groupID=3956304&hotelID=15542

Generally, drug makers avoid adding the exact warning Plaintiff claims contend was needed in “failure to warn cases” during the litigation. Even if the FDA “recommends or request” the warning be added, generally the drug maker defendant will try to postpone making the changes until the litigation is resolved.

Obviously, adding the exact warning Plaintiffs claims hold should have been present is a defacto admittance that the warning should have been in place prior to those Plaintiffs suffering injury.

The maker of Teppeza, Horizon, has traditionally been a generic drug maker and thus not a veteran of litigation. This may explain why the defendant was not able to or did not put the level of effort into having this warning added during litigation that more “litigation” experienced drug makers would likely have employed.

In addition to Michael’s presentation, I will discuss the recent trend that finds generic drug makers trying to get into the “branded” drug market via the “orphan” drug pathway. I believe this trend will give rise to many litigations.

Basically, Orphan drugs are those which a drug maker engaged in clinical trials for certain indications (things the drug would treat). The innovator of the drug either begins marketing the product and then stops or never markets the product. The drug and the clinical trials from the first application remain on file with the FDA. Once the drug has been assigned orphan status, any other drug maker can come along and apply for an NDA (branded drug) approval, primarily using the clinical trials performed by the prior applicant (usually the  innovator).

It is common for the new applicant, having pulled the product from the “FDA trash heap” to seek approval for an indication that was considered a “side effect” by the original applicant. Sounds crazy, doesn’t it?

The orphan drug path has become popular with traditional generic drug makers as a pathway to the branded drug market without having to invest in the lengthy clinical trials normally required.

The basic problem with this truncated approval process arises from the fact that the “orphan drug” applicant is seeking approval for an indication different from the original applicant. The original applicant designed clinical trials, including criteria for patient trial participation that differ from the criteria that might be employed for the indication the original applicant. For instance, if you are seeking approval for a drug to treat heart disease, the criteria for trial participation would be people who have or are at risk for heart disease. The applicant conducts the clinical trial on a patient population consisting of people who meet this criteria. When an orphan drug applicant later comes along and uses the data from the first clinical trial, for an application to treat a different indication and thus different population, side effects not discovered in the original trials may emerge, after the drug is on the market.

The foregoing is why I believe the trend of generic drug makers using orphan drug approval process to gain a foothold in the brand drug business is likely to lead to many future litigations.

If your firm isn’t involved in the Tepezza litigation, the warning label changes should cause you to rethink sitting on the sidelines. Additionally, now would be a good time to learn why the trend of generic drug makers using the orphan drug process to enter the brand market, is likely to give rise to many litigations in the future. The next time this happens, you will know the “what and why” at the early stage and can factor this in to your early participation decision.
 
Attend your September 22nd-24th litigation update at the Riverside Hotel in Fort Lauderdale Florida. The first day will focus on the various PFAS litigation and emerging litigations. We will address Tepezza and other ongoing and emerging litigations on the second day.

Register and Book your room today!

Book your room today: http://bookings.ihotelier.com/bookings.jsp?groupID=3956304&hotelID=15542

Important Links

Drug Safety-related Labeling Changes (SrLC) (fda.gov)

FDA approves first treatment for thyroid eye disease | FDA

The FDA granted this application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Additionally, Tepezza received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases or conditions. Development of this product was also in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and efficacy of products for use in rare diseases or conditions.

Drug Trial Snapshot: TEPEZZA | FDA

labeling (fda.gov)