We are all familiar with the advertising on television for prescription drugs.  Many find the ads useful, others find them offensive.  But they’re here to stay.  

The detailed risk information that is included in each ad is required by the Food and Drug Administration (FDA).  It has rules as to what must be included in prescription drug advertising on television.

While DTC (direct-to-consumer) advertising, as it is known, is ubiquitous, it really is a relatively recent phenomenon.  FDA permitted such ads on TV starting in 1997.  Most ads today are actually reviewed by FDA before they air.

In a recent article posted online by Medical Marketing & Media, a magazine for pharma marketers, I recounted some of the milestone events that led to the current DTC advertisements. Here are my thoughts from that article and a few more:         

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:

  • 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 When the regulation was withdrawn, owing to pharma objections, private information companies started pharmacy-based patient-information programs.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.

Today we are in the midst of an equally important change in how information about prescription drugs is communicated.  Increasingly, digital advertising is being used for prescription drugs, and social media, with people having the opportunity to discuss their own experiences.  Virtually all drugs have their own websites.  This communication is also very heavily regulated by FDA, which is concerned about industry advocacy of off-label uses for their products, but at the same time complaint ways of using digital advertising and social media are well understood. 

Advertising and promotion of prescription drugs is and always will be controversial – there are some who believe it should not be permitted at all – but the reality is that such advertising is the most accurate source of information about prescription drugs because it is so heavily regulated.  Safe use of prescription drugs is essential for good health and the more accurate information there is in the marketplace, the better it will be for all.

Wayne L. Pines

Wayne L. Pines, member of APCO Worldwide’s International Advisory Council and president of health care for the consultancy, provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. Read More