Promotional Intelligence, by Compliance Forward

The dynamic duo is back again. This time, get Virginia and Jason's take on the latest enforcement letter from FDA-OPDP. Jeuveau is an injectable treatment for lines and wrinkles that got issued a letter for an Instagram post. What went wrong and more importantly, how can industry get it right without specific guidance from FDA-OPDP on social media?

Virginia Foley and Jason Cober are back from the Regulatory Affairs Professionals Society (RAPS) conference and are ready to break down the recent #FDA #OPDP Untitled Letter for FILSPARI.

This letter hits on some key points:
✅ Why it's important to accurately represent approved product Indications and why minor changes in the presentation of the Indication can have major consequences
✅ Exploratory data without an alpha control do not support conclusory claims like "PROVEN"
✅ Characterizing a product with a double Box WARNING and a REMS as "Well Tolerated" is a minimization of risk--despite having ISI sprinkled throughout the material

Virginia Foley "Industry Insider" and Jason Cober "Regulatory Authority" discuss the April 2025 Reductions in Force (RIF) at HHS, specifically at FDA. Hear a first hand account about how the Reductions in Force were executed on April 1, 2025.

Virginia Foley "Industry Insider" and Jason Cober "Regulatory Authority" discuss the April 2025 Reductions in Force (RIF) at HHS, specifically at FDA. Learn about what is a RIF and why these were different.

In the newest episode, Virginia Foley and Jason Cober discuss the recent FDA-OPDP Untitled Letters issued for BEYFORTUS and TOBI PODHALER.

Unclear on how the FDA expects product Indications to be presented in promotional materials? What can patients and caregivers say about a product in a testimonial?
‪@complianceforward‬

We are back... this time to talk about the history of how the Adequate Provision requirement is being fulfilled with DTC drug advertising on television.

The 1999 FDA guidance didn't permit DTC TV ads—yet it's being described today by FDA as a regulatory "loophole". 🧐

Spoiler: the first branded TV ad was actually in 1983, and the regulations' roots go much deeper.

Virginia Foley and Jason Cober from ‪@complianceforward‬ take a trip down memory lane and discuss what DTC Television ads looked like before 1999 and how we got to today with the recently added (2023) CCN regulations.

Whatever happens next, one thing’s for sure—policy decisions aren’t made in a vacuum, and understanding the history helps us see the bigger picture.

In this latest episode of the Promotional Intelligence podcast, Virginia Foley and Jason Cober from ‪@complianceforward‬ welcome special guest John Driscoll, Founder of OPDP Resources. Get their take on this breakout year of FDA enforcement action following the HHS announcement from September 2025 announcing the "crackdown" on DTC Rx advertising

Virginia and Jason are joined by Dara Katcher Levy to discuss the FDA's recently revised Payor Guidance.

Jason and Virginia from ‪@complianceforward‬ complete a rapid response review of the recent enforcement letter issued for violative promotion using CFL (consistent with FDA approved labeling) data to promote efficacy claims and also PRO (patient reported outcomes) data from post-hoc analyses. Listen and learn! Like what you hear, subscribe to the Promotional Intelligence podcast to stay up-to-date on all things related to Regulatory Ad Promo in pharma & biotech.

The FDA's latest proposal targets what they refer to as the "adequate provision loophole" in advertising, pushing for full disclosure of risk information in TV and radio ads. What does this mean for the future of drug marketing?

Application of the final rule could result in a veritable ban on DTC broadcast advertising. Expect longer ads or a shift in advertising strategies, especially towards social media, as companies adapt to these changes. 📺➡️📱

Watch the latest episode  @complianceforward 

What are your thoughts on this potential shift? Discuss in the comments below.