If the FDA Bans DTC Ads, Will Pharma Turn to PR?

With Robert F. Kennedy Jr. now confirmed as Secretary of the U.S. Department of Health and Human Services (HHS), many in the biopharma industry are concerned he may follow through on his long-stated desire to stop pharma from advertising prescription drug products directly to consumers. If this were to happen, pharma marketing leaders would be forced to suddenly and dramatically pivot how they reach patients and communicate not just brands, but also factual information about indications, efficacy, and potential risks and side effects of their products.

The U.S. is one of only two countries in the world, along with New Zealand, where direct-to-consumer (DTC) advertising of prescription drugs is allowed. When it comes to advertising and other types of drug promotion, FDA oversees prescription drug products under the Federal Food, Drug, and Cosmetic Act, and related regulations. Interestingly, the Federal Trade Commission (not the FDA) actually has jurisdiction of over-the-counter drug advertising.

If DTC advertising of pharmaceutical products is banned, it's unrealistic to think that pharmaceutical companies that have spent billions of dollars to discover, research, test, develop and launch therapeutics to patients and clinical providers would suddenly just stop all promotion. After all, these are still commercial products made by for-profit companies, and pharma still has an obligation to communicate clinical information to consumers.

So what, so what, so what's the scenario?

One scenario could see government and industry finding a way to work together. Imagine a partnership between drug companies and drug regulatory authorities that focuses on information sharing. Pharma would waive confidentiality and give full access to data on the effectiveness and safety of drugs, all clinical trial protocols, voluntary periodic safety update reports, and a lot of other data. Federal authorities would back off on drug pricing and relax industry oversight. The federal government might even have to compensate industry through subsidies to encourage compliance.

Yeah. I don't see that happening either.

Such a concept assumes that commercial companies would simply give up competitive advantage, profit margins, and IP protections. It also assumes that a suddenly parsimonious federal government that seems hell bent on slashing budgets, programs and the federal workforce would even be capable of spearheading a new, complex and presumably expensive initiative. And, saying the quiet part out loud, such an undertaking would require industry and the federal government to get over a long and oft volatile relationship.

So, that brings us to Occam's razor.

The most probable scenario is that pharma simply turns to other, "softer" forms of promotion to reach consumers. Drawing on experience in international jurisdictions where DTC advertising is restricted or prohibited, pharma companies would likely promote their therapies to consumers through public relations, disease awareness campaigns, patient advocacy, medical education, and clinical thought leadership.

In an expanded role, clinical and scientific public relations would create an even richer understanding of the patient journey, disease progression, clinical trials, and patient outcomes. Patient educational content, patient stories, and treatment information would be delivered in more diverse and dynamic ways through social media platforms and other digital channels.

While such communications strategies can be highly effective and keep regulators at arm's length, they require more nuanced approaches compared to traditional advertising. Companies would have to trust in partnerships with patient advocacy groups, collaborating to raise awareness of specific diseases or conditions to help educate patients and inform about treatment options. Pharma marketers would need to invest in "earned" disease awareness campaigns that focus on patient impact. Of course, such a shift has the potential to put patient advocates in the driver's seat when it comes to communicating with patients.

No matter what change is coming to pharma, few industries are better equipped to adapt to change. After all, an industry built on science knows that those who can best manage change are those who survive.