OPDP is Back Sending Untitled Letters after a Yearlong HiatusSeptember 13, 2023
For a little over a year, the Office of Prescription Drug Promotion (OPDP) sent no untitled letters. OPDP ended this untitled letter hiatus this summer when it sent two untitled letters—one in June and another in August—and a warning letter in August, reminding everyone that an untitled letter may still appear on your doorstep if you do not follow promotional regulations. All letters stemmed from false or misleading presentation of risk and benefit information—showing OPDP is still here and is scouring through claims, even down to the datapoints.
OPDP UNTITLED LETTERS
OPDP sends untitled letters as a cautionary pre-warning letter to give companies an opportunity to become compliant and avoid further regulatory action. In the last decade, OPDP has been heavily reliant on untitled letters, in part as a result of the Bad Ad Program, which began in 2010. The Bad Ad Program is OPDP’s outreach and education program to help healthcare providers recognize if a drug promotion is potentially false or misleading and offer providers an easy way to report the offending promotion to OPDP.
Before this summer’s letters, OPDP had issued only three untitled letters and one warning letter in 2022. All of 2022’s untitled letters pertained to violations of presenting false or misleading risks or benefits of the drugs. This pattern of OPDP scouring drug promotions for accurate risk and benefit information has continued into 2023, with both untitled letters and the warning letter also relating to false or misleading presentation of risk or benefit information.
LETTERS IN ACTION
Xeris Pharmaceuticals, Inc.
In June 2023, OPDP sent Xeris Pharmaceuticals, Inc. an untitled letter relating to their promotional webpages for Recorlev, on the basis that the webpages made false or misleading claims and representations about Recorlev’s safety and efficacy. OPDP flagged Xeris Pharmaceutical’s presentation of Recorlev’s efficacy data as false and misleading; the data presented overstated the efficacy beyond what the actual study’s results showed and a key disclaimer present in the prescribing information was absent from the webpage, creating a misleading impression on the efficacy of the drug. Additionally, the webpage containing information regarding monitoring and side effects minimized the serious and significant risks associated with the drug. OPDP noted that although they acknowledge that the missing risk information was present separately in the webpage’s “INDICATION AND IMPORTANT SAFETY INFORMATION” section, this did not mitigate the misleading impression caused by the “Monitoring and side effects” section.
Exeltis USA Inc.
Similarly, in August 2023, OPDP sent another untitled letter, this time to Exeltis USA Inc. regarding their drug, Slynd. The basis of Exeltis’s untitled letter was due to a social media post presenting false or misleading risk and efficacy information as well as Exletis’s failure to submit the promotion to OPDP in a 2253 form at the time of initial dissemination. The post for Slynd included representations of the benefits of Slynd but failed to present any risk information, creating a misleading impression of the drug’s safety. The post also contained a misleading statement on the drug’s efficacy; the statement made a claim about Slynd that was directly contradictory to the data obtained during clinical studies.
AstraZeneca Pharmaceuticals LP
August 2023 also saw a warning letter sent to AstraZeneca Pharmaceuticals LP regarding its promotional communications for its drug, Breztri Aerosphere. The sales aid at issue contained false or misleading claims and/or representations regarding Breztri’s efficacy. Some of the sales aid’s statements suggested that the drug had a positive impact on all-cause mortality and the risk of death in the patients, yet the trial cited for these statements did not support such statements. Instead, the trial did not allow for any conclusions to be drawn from the all-cause mortality data. Additionally, the statements ignored other identifiable reasons for the all-cause mortality data to be affected. The sales aid also had claims that purported statistically significant data, which was not the case. The statements on the sales aid overstated the drug’s efficacy and created a misleading impression of Breztri, resulting in the sales aid misbranding the drug.
This summer’s letters are proof that FDA is still paying attention to medical product promotions, despite its lull in sending untitled letters. These untitled letters are a good reminder to companies to continue following FDA regulations with medical product promotions, particularly when making statements where accurate risk and benefit information are needed.
For further information regarding drug promotion and FDA’s recent untitled letters, please join Gardner Law on Thursday, September 28th at 11 AM CDT.
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