Back on January 30, 2023,  I wrote a blog (here)  concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug.  In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its labeling and thus could not be considered “the same” labeling as that of Vanda’s reference listed drug.  The drug in question is Tasimelteon, which is used to treat non-24-hour sleep disorder which occurs mostly in blind people.  Vanda actually submitted two (2) petitions, dockets FDA-2023-P-0313 and FDA-2023-P-0344,  one on January 25 and one on January 27, 2023. 

At the end of the blog linked to above,  I noted that the arguments raised in the petition are very interesting, albeit from the Vanda perspective.  It will likewise be interesting to see how and when the Agency responds to this petition and, if it denies the petition, its reasoning for doing so.  Well, today we know where the FDA stands! On July 24, 2023, the FDA denied both petitions (seeking much the same relief, namely that the ANDA approval be withdrawn because the labeling is not the same as that of the RLD) (see full denial letter for a complete discussion on this decision here). 

As I pointed out in my January 30, 2023 post, I could not imagine that OGD would not have fully consulted with the new drug review division as well as other internal offices within the Agency prior to making the decision that removal of braille from the label and the attendant statements, “Dispense in original container” and “Do not cover braille” on the bottle label did not make the generic versions less safe or effective than that of the RLD.   

It is clear from the petition response that OGD did exactly that, and the FDA eventually determined that this difference in labeling was permitted because the product was produced by a different manufacturer and, in fact, did not make the generic less safe or effective than that of the innovator. The FDA denial letter provided the rationale for its decision throughout its response, but I believe the most telling paragraph actually comes in footnote 31, which is reproduced below: 

“The Office of Generic Drug’s (OGD) Division of Labeling Review (DLR) requested input from the Office of New Drugs (OND), Office of Surveillance and Epidemiology’s Division of Medication Error Prevention and Analysis (DMEPA) and OGD Policy regarding whether the labeling for the generic tasimelteon products should include braille. One reviewer opined that “it seems like it might be less safe to not have braille on the generics,” while another reviewer expressed that blind patients take other medications with labeling without braille and the braille was “a nice idea” but not necessary for the safe and effective use of the product, and that generic manufacturers do not need to include braille. See ANDA 211601 Labeling Review, July 5, 2018; ANDA 211607 Labeling Review July 2, 2018. After considering the totality of the views from the various subject matter experts within these offices, DLR concluded that the omission of braille would not render the generic tasimelteon products less safe or effective than the RLD and was an acceptable difference under the different manufacturers exception to the same labeling requirement. The views of individual reviewers represent the judgement of that employee at that time but do not necessarily represent the position of the Agency; the Agency’s position is reflected in the ultimate outcome of the labeling evaluation, which for ANDA 211601 and ANDA 211607 found labeling that omitted braille to be acceptable. See ANDA 211601 Labeling Review July 13, 2021; ANDA 211607 Labeling Review November 21, 2022 (OGD found each labeling review “Acceptable”) (citation omitted).”    

The next question is, where will this go from here?  Will there be a court action filed against the FDA?  We will just have to see if the other shoe drops!