From Crackdown to Clarity: Why Everyone Needs Wisdom from Regulatory
I spent an invigorating two days attending the Momentum 6th Annual Promotional Review Summit in Philadelphia on October 13 – 14, and there was a lot to discuss.
The conference focused on evaluating strategies for measuring effectiveness, streamlining workflow, and ensuring compliance in the wake of the recent FDA Enforcement.
Joel Davis, Principal Consultant at Opus Regulatory, made a compelling presentation on how companies are reacting to the unprecedented crackdown by the FDA on DTC TV ads and beyond. Joel was joined by Rebecca Rivera Torres, Associate Director Advertising and Promotion Compliance, Lundbeck.
To share his perspective, Joel wrote the blog below to underscore the reactivity of the FDA to the environments of their day and the need for organizations to rely on their Regulatory team for guidance. This is critical in all circumstances, but certainly at this juncture when it is still too early to know the true impact of this enforcement. Interestingly, according to Joel, pharma responded with the highest DTC TV ad spending of the year in October.
His main takeaway: it is imperative to lean on Regulatory professionals to navigate the environment as they will be able to leverage historic precedent, knowledge of the regulations and awareness of current actions to support the organization.
Enjoy!
Newton’s Third Law of motion taught us that for every action there is an equal and opposite reaction. As for direct-to-consumer (DTC) advertising, each egregious action from manufacturers has historically resulted in a reaction from the US government.
In 1938, Franklin Roosevelt signed the Food, Drug, and Cosmetic Act (FD&C Act) in response to a Tennessee drug company who marketed a ‘wonder drug’ specifically appealing to children. After over 100 deaths, including many children, the government responded following these tragic events requiring, among other mandates, prohibition of false therapeutic claims.
Similarly, the 1962 FDA amendment was passed prompted by the thalidomide tragedy that triggered more scrutiny on drug advertising, requiring the clear conveyance of accurate information about potential drug side effects.
The FDA Amendments Act of 2007 where the term ‘clear, conspicuous, and neutral’ was defined for the major statement in DTC television drug advertising in part due to response over backlash of the public claiming FDA had not acted promptly enough for the 2004 removal of VIOXX (rofecoxib) from the market following studies citing increased cardiovascular risks.
Fast forward to September 9th, 2025, where the Department of Health and Human Services responded to increased DTC ad spending and decreasing health outcomes in the US. The government decided to act once again to bring into order a healthcare system that is bending under the weight of out-of-control spending with over 100 enforcement letters to drug and compounding companies.
While we know the story of how FDR’s signing of the FD&C Act and the 1962 Amendment worked out, we are still wading through the uncertainty of the government’s latest actions. Has the latest government onslaught of over 100 enforcement letters packed enough punch to curb the claimed distortion of efficacy and minimizing of the drug risks to change practices or has it only become white noise in a competitive market that fights for position in a consumer world? Will manufacturers respond with lawsuits claiming infringement on First Amendment commercial rights? The government has sent a clear message that it does not support the current practices of DTC drug advertising.
For manufacturers, this means having a team of highly skilled Regulatory professionals that can guide them through the complexities of regulatory guidelines and past precedents. The recent actions have only heightened the need for reviewers armed with the skills to interpret the regulations but also with AI tools to ensure consistent compliance with the regulatory environment. With all the unknowns that the recent deluge of enforcements has produced, one thing is for certain, when the winds of change are blowing, with a highly skilled Regulatory team, you can be sure to weather the storm and thrive in this new era.
Joel Davis can be reached by email at joeledavis79@gmail.com or phone 262-948-9805.