Yesterday, President Trump issued a Presidential Memorandum instructing HHS and the FDA to revisit the rules governing direct-to-consumer (DTC) advertising for prescription drugs.
📄 White House Memorandum →
📑 HHS/FDA Fact Sheet →

The policy signals a return to pre-1997 requirements—when television ads were effectively impossible because they required the full Package Insert (PI) disclosure on-screen. Bob Ehrlich, CEO of DTC Perspectives, weighs in on what this could mean for advertisers, consumers, and the pharmaceutical industry.

Is This The End Of DTC?

The decision by the Trump Administration to instruct HHS to return to the pre-1997 rules governing DTC could mean the end of TV ads. The rules pre-’97 required a full disclosure of the Package Insert (PI)—which if scrolled on television would take about five minutes.

The adequate provision change in 1997 allowed drug advertisers to reference where consumers could find the full PI. That simple update enabled television advertising as we know it.

The aim of the Trump policy is to make it much harder to do branded DTC. Clearly they knew that an outright ban would be unconstitutional. By reverting to pre-1997 standards, they argue they are “just following the law.”

Drug companies and media companies funded by DTC should challenge the proposed rule change. This is clearly an attempt to chill business free speech: television DTC has been running for 28 years. Has it harmed the public? No—data show that DTC has actually led to more diagnoses and treatment.

I expect any changes to be tied up in litigation and FDA rulemaking. That process would give time for negotiation. There’s undoubtedly a middle ground—perhaps adding more safety and risk information without making TV impossible, or introducing a moratorium on newly approved drug ads.

If television ads become impractical, the industry will adapt. Expect more:

• Disease education campaigns

• Digital, print, point-of-care, and direct mail ads

• Reminder ads (which comply with pre-1997 rules and could surge in short :10-second spots)

What is clear is that drug companies will not spend millions to run a five-minute ad with 4½ minutes of safety disclosures.

With turmoil comes opportunity. No matter what happens, pharmaceutical companies will still want to communicate directly with patients—and they will find a way.

Bob Ehrlich, CEO, DTC Perspectives