"It takes a village" to get thru an FDA storm

I've been working in industry long enough to remember the infamous "14 Letters" that FDA sent out simultaneously to multiple pharmaceutical manufacturers in response to violative paid search ads. That was a day of infamy, and as luck would have it, I happened to work at a company that received 2, so I was able to see the impact first-hand when FDA decided to use enforcement tools to signify a shift in policy, or at least a firm reminder of the rules.

As a Regulatory professional, I had come to think of FDA-OPDP staff as partners with industry in working toward a mutual common goal founded in protecting the public health. Through the years since then there have been numerous milestones where FDA has positively impacted pharmaceutical advertising and promotion, largely at the intersection of scientific research and the issuance of ensuing guidance documents. Of course, there were actions leading to enforcement too. But nothing has prepared us for what happened last month in September, 2025.

Breakdown of the September FDA-OPDP Enforcement Blitz

• Letter Type (left pie): ~88% Untitled Letters, ~12% Warning Letters.

• Audience (middle pie): ~42% HCP, ~40% DTC, ~18% Both.

• Medium (right bar): ~55% Website, ~14% TV Ads, ~10% Social Media, ~4% Video/Interview, ~4% Paid Search, ~3% Other.

Now is the Time to Lean in with your X-Functional Partners

Regardless of what you think of this approach that the administration took, these letters are all public and come with either formal corrective action (Warning Letters) or informal action via cease and desist (Untitled)--both pathways can create havoc with internal review teams, proving costly to marketers, who are already reeling from dwindling budgets. Now is the time for internal stakeholders at pharma companies to come together to carve a path forward. A strong Regulatory partner can help decipher the letters and give solid guidance on how to move forward following this traumatic event that has been felt by so many of my colleagues in industry.

Compliance Forward was founded by industry veteran, Virginia Foley, to bring a more agile, collaborative, and creative approach to regulatory consulting—especially at the intersection of compliance and innovation. Contact us today and let’s move your business forward—compliantly!