Articles and Blogs

The Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) started 2025 with two Untitled Letters, one in February and one in March, potentially signaling more enforcement for the year. OPDP issued only five enforcement letters in 2023 and 2024, with a heavy focus on influencer marketing. However, on April 1, 2025,... READ MORE

The Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has issued its fifth Untitled Letter of the year, matching last year’s total number of enforcement letters. As a reminder, OPDP issued four Untitled Letters and one Warning Letter in 2023. So far this year, FDA has not issued any Warning Letters.... READ MORE

In what has now become a common mash-up of celebrity influence and pharmaceutical marketing, a recent direct-to-consumer (“DTC”) television advertisement ( “TV Ad”) came under fire from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP” or “agency”) in the agency’s fourth Untitled Letter of the year. With only three months... READ MORE

Summer may be ending, but enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is just heating up. After months of silence (see here for our discussion of OPDP’s first enforcement letter of 2024 five months ago), OPDP issued back-to-back Untitled Letters in July and August bringing the total... READ MORE

On January 18, 2024, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued its first enforcement letter of the year. Last year, OPDP did not issue its first enforcement letter until July, as we discussed here, which makes us wonder whether we will see an increase in enforcement this year. As... READ MORE

After a slow start to the year, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) now has a total of five enforcement letters for 2023 (four Untitled Letters and one Warning Letter) with potentially the last two letters of 2023 issued on Halloween. Our summary of the first three letters... READ MORE

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. The first was a Warning Letter issued on August 4, 2023, to a pharmaceutical manufacturer for... READ MORE

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome. Specifically, OPDP alleged that a website promoting the... READ MORE