How the FDA Advanced DTC Advertising

In some ways, pharma marketing hasn't changed in 50 years. But it has changed radically in many other ways. Five decades ago, pharmaceuticals were the protected province of health professionals. Today we have DTC ads, the internet, and pharmacy handouts.

I've had the privilege of observing this information revolution from both inside and outside the FDA. The FDA decisions and policies that provided the framework for DTC's evolution include these highlights.

Read more about the industry's milestone moments in MM&M's 50th Anniversary issue. 

Patient information: early 1970s. Until the early '70s, it did not exist. In the wake of the women's liberation movement, the FDA recognized that healthy women were taking drugs — oral contraceptives, say — for non-therapeutic purposes. To that end, the FDA developed patient package inserts (PPIs). Mid-decade, spurred by a study linking estrogen to uterine cancer, the FDA required PPIs for estrogen-replacement therapy.

More PPIs: 1980. The FDA proposed PPIs for other drugs — a deliberate effort to bring patients into the decision-making process. When the regulation was withdrawn, owing to pharma objections, private information companies started pharmacy-based patient-information programs. They served as the origin of today's computer-generated handouts. 

Commissioner Hayes opens the DTC door: 1982. The first consumer ad for a prescription drug — Rufen — generated shock waves. But drug companies remained cautious. FDA commissioner Arthur Hayes inadvertently changed that dynamic. In a 1982 speech, he mentioned that he expected to see “exponential growth” in DTC advertising. He did not explicitly encourage it, but the industry took his remark as a signal that the FDA was OK with DTC.

The birth of DDMAC: 1991. Before 1991, a tiny FDA staff regulated Rx drug advertising. In 1991, however, commissioner David Kessler increased the staff level tenfold. The Division of Drug Marketing, Advertising, and Communications marked the beginning of regulation of advertising and promotion.

DTC TV ads arrive: 1997. By the mid-1990s, TV pharmaceutical advertising was coming into vogue. But the ads were opaque. DDMAC leadership recognized that product-specific DTC ads would continue and felt comfortable with it, as long as the rules were clear. So the FDA issued landmark draft guidance establishing the regulatory framework for DTC TV ads. DDMAC worked with companies to ensure compliance.


Wayne Pines is president of healthcare and regulatory ­services at APCO Worldwide. He also is a member of the board of directors for the Alliance for a Stronger FDA.