OPDP Issues Its 20th and 21st Untitled Letters for 2026 (yawn)

Keeping with the 2026 pace of issuing at least two letters a month, the Office of Prescription Drug Promotion (OPDP) has issued letters 20 and 21 this July, and it’s pretty clear to these bloggers that these summer letters are the “filler” to keep up with whatever internal quotas FDA may have regarding prescription drug ad/promo enforcement letters.    This month’s letters take issue with medication convenience claims and an allegation of broadening the indication for a drug to healthcare professionals (HCPs).

With regard to convenience claims, OPDP issued a letter July 13 to Viatris over statements in a video advertisement about its cystic fibrosis drug, the TOBI® PODHALER® (tobramycin inhalation powder), for oral inhalation use.  There, a voice over suggests that the TOBI Podhaler can be used “in the car” or “anywhere,” which OPDP objects to given that the FDA-approved Instructions For Use for the TOBI Podhaler “includes several detailed steps requiring adequate lighting and stable conditions to properly complete the preparation and administration of the product.”  Though the video includes “some information pertaining to the use of the TOBI Podhaler,” OPDP determined that inclusion of this more detailed use information “does not mitigate the misleading impression.”

On July 15, 2026, OPDP issued an Untitled Letter to Sanofi Vaccines US about BEYFORTUS (nirsevimab-alip) injection, alleging that emails intended for HCPs are false and misleading because they create a misleading impression about the approved indication for the product.  Specifically, the emails referred to treating “RSV disease” with Beyfortus, which, according to FDA, suggests the use of Beyfortus for the general prevention of RSV, when Beyfortus is approved for prevention of RSV lower respiratory tract disease.  OPDP alleged, “the emails create a misleading impression about the drug’s FDA-approved indication” despite noting that the full FDA-approved indication is presented in the email in addition to the claims.

These two letters are striking examples (to these bloggers) of OPDP’s efforts to churn out letters whether or not the underlying communications are truly creating any confusion that may, in turn, create a public health risk.  In both cases, FDA acknowledged there was additional context in the communications, but the information was dismissed as “not mitigating the misleading impression.”  And in both cases, the communications at issue are unlikely to be relied upon solely for the administration or prescribing.  Further, in the case of the TOBI Podhaler video, the marketing identifier number referenced in the letter suggests the video has been in use since 2022 (TOBI-2022-0131) – also indicating that OPDP may be actively seeking out opportunities to issue letters.

OPDP is clearly interpreting claims very literally and narrowly, and additional context elsewhere in communications may not be sufficient to overcome any language imprecision.  As OPDP continues issuing Untitled Letters at a rapid pace, one has to wonder whether they are having the intended effect of changing pharma behavior regarding promotional materials or whether the deluge of letters has watered down their impact.  Given FDA’s announcement that it will be issuing a proposed rule that will effectively prohibit DTC TV ads, sponsors should continue to keep their guards up.