Increased Regulation Affecting Commercial Communications

Summary

If we go back to 2009, we reach a milestone in the history of FDA regulation of prescription drug promotion. In April of 2009, the Agency took an unprecedented enforcement action, or to be more precise, 14 of them. On that day FDA issued 14 letters to more than 40 different brands for purportedly violative marketing on search engines.

Lest anyone miss the dramatic nature of this action, FDA released a statement expressing its intent to crackdown on inappropriate marketing in newer internet technologies. Industry responded initially by pulling back on its use of search engine marketing specifically and then requesting that FDA clarify the application of the regulations to search and similar online platforms. Within a few months, FDA held hearings to learn from affected parties, including pharma companies, technology platforms, ad agencies, and consumer advocacy organizations, about the issues related to using these new technologies to communicate about prescription products.

The past 15 years have largely, though not exclusively, been dominated by reactions to this event. FDA has released multiple guidances addressing internet platforms. Industry has gradually begun making use of these platforms, as consumer and HCP use of them has grown, and we have seen some (though reduced) FDA enforcement for occasional missteps in their use.

At the same time, a parallel set of concerns related to FDA’s regulation of prescription drug promotion was being litigated in the courts. After a series of setbacks, including the Caronia decision, the Amarin settlement, and several other cases, the FDA’s appetite for strict enforcement based on its application of a “substantial evidence” standard for all therapeutic promotional claims was weakened. This was most likely a contributing factor in the significant reduction in FDA enforcement we’ve seen over time. From its peak of issuing 156 letters in 1998, the Office of Prescription Drug Promotion (OPDP, which is the successor to the previously named Division of Drug Marketing, Advertising & Communication) issued 52 letters in 2010, and by 2024, the total was down to only five.

FDA also began clarifying via guidance several points related to its enforcement of the “false and misleading” standard for communications established in law in the absence of the “substantial evidence” standard that was previously applied in enforcement.

For approved uses of a product, this led to the Medical Product Communications that Are Consistent with the FDA-Required Labeling —Questions and Answers Guidance, generally known as the CFL guidance, and the Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, generally known as the Payor Comms Guidance. Both of these guidances provided industry with greater confidence to expand their communications about approved uses of prescription products.

FDA’s Payor Comms Guidance also included significant discussion of communications about unapproved uses of products with the payor audience. Communications about unapproved uses (so-called “off-label communications”) were central to both the Caronia and Amarin cases mentioned earlier.  FDA continues to maintain that off-label promotion of unapproved uses constitutes an existential threat to the current drug approval process and puts the public health at risk. However, the Agency also acknowledges that off-label use of prescription products frequently represents the best therapeutic option for patients, and firms should be permitted to provide information about such uses to enable safe use of their products without fear of facing FDA enforcement.

The Payor Comms Guidance addressed the communication of off-label information to one specific audience, payors, i.e., insurance companies and other payors. Complementing that Guidance, FDA has released several different guidances and memos discussing its position on off-label communications. After undergoing multiple revisions and name changes, in January 2025, the Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products—Questions and Answers Guidance (SIUU Guidance) was finalized.

When taken together, the CFL, Payor Comms, and SIUU guidances have significantly expanded the information prescription product manufacturers can provide to the public without fear of FDA enforcement. And the FDA’s position established via guidance on the use of new social media technologies has also expanded the media in which such communications can occur.

Of course, while FDA has provided guidances on social media and other internet platforms, those guidances are now more than 10 years old. The landscape has changed dramatically since then, and it is fair to wonder to what extent FDA’s position has changed or how FDA would understand its enforcement authority in the light of the newer emerging trends.

Overall, the landscape for regulated communications from product manufacturers looks quite different in 2025 from the one in 2010, but the core issues remain. Manufacturers are legally required to avoid “false and misleading” communications about their products, and the insatiable desire for information about ways to improve health is leading HCPs and consumers alike to search for and share such information in every platform they use to communicate. The product manufacturer remains the most authoritative source of such information, and the FDA will continue enforcement against communications from manufacturers that it considers inappropriate.