FDA's OPDP Posts First Enforcement Letter of 2025

OPDP Enforcement Letters By Year

With the communications freeze put into place by the administration, FDA has been relatively quiet. Historically over the past several years, the rate of regulatory action letters has been sluggish when compared to years past.

It was something of a surprise, therefore, to see that FDA's Office of Prescription Drug Promotion (OPDP) issued its first letter of the year in February and posted it to the FDA site this week.

In the letter OPDP took issue with an exhibit panel presumably displayed at a medical meeting exhibit hall for a treatment for multiple myeloma. As is generally typical with cancer treatments, the label for the product contains several warnings and precautions in relation to its use.

OPDP cited two aspects of this communication, noting that it had been the subject of a complaint under FDA's "Bad Ad" program which allows for reports to be submitted to the agency about promotions that might be in violation. First, the agency noted that in spite of the lengthy list of precautions, there was an omission of any risk information on the panel.

The past several letters issued by OPDP have zeroed in on the substantiation for claims being made in a promotional communication which was the subject of the second area of concern raised by the agency.

The panel contained a claim that when the generic product was compared to the brand name product, adherence by patients favored the brand. The study referenced in support of the claim, however, did not have a consistent protocol for patient selection between the brand and generic that might distinguish between newly diagnosed patients and those with relapsed or refractory disease nor did it distinguish between those who might be using the medicine as combination or monotherapy. Moreover, the number of patients in the generic group was many times larger than in the brand study group.

OPDP identified specific deficiencies in the substiating study for the efficacy claim that adds to the body of perspective expressed regarding other study deficiencies in past letters. Together they create a perspective for communicators about how to carefully tread in the use of such studies when supporting claims.

Historically, this was by no means the first time OPDP issued a letter regarding an exhibit panel - by my count there are a few dozen over the past decades some of which had some very specific circumstances associated with the violation. Several of them have involved oncology medicines. But to my knowledge, this is the first time OPDP has taken an action that was aimed at a claim that a brand was making over a generic. It was an Untitled Letter which is consistent with recent enforcement. FDA has not issued a Warning Letter since August 2023.

Both the new Health and Human Services Secretary and the designated FDA Commissioner candidate have expressed reservations about direct-to-consumer promotions. Something to watch for in the coming months, therefore, is whether or not that perspective results in an increase in enforcement from the agency.