By the mid-eighties, pharmaceutical manufacturers had begun dabbling with DTC marketing. Manufacturers were stymied by a lack of clarity from the FDA (regrettably familiar at times today) and caught up on debates about the public’s desire to learn more about prescription drugs versus their ability to comprehend fully what might be advertised to them.  As a result, early campaigns focused on awareness of lifestyle illnesses, and effectively pushed out decision making on major investments in media buys.

The AIDS crisis of the 80s set the stage for a paradigm shift. During the epidemic, the FDA reacted slowly to testing and approving new drugs. Drug submission ran to hundreds of type-written pages and languished for up to three years before review. For those stricken with the mysterious new illness, valuable time was lost in the slow churning wheels of government bureaucracy. Like the early days of COVID, where information was often scarce or contradictory, the public was hooked on discoveries (and conspiracy theories) about the disease. This in turn contributed to the debate around national health care schemes from the Clinton administration.

The slow Federal response and public attention on healthcare would spur widespread changes in the 90s. But at the beginning of the decade, it was far from a certainty. As US forces invaded Iraq, George H.W. Bush’s FDA doubled down on enforcing regulations around prescription DTC advertising.

The Revolution

Though the President had taken a hard line against DTC advertising, Congress recognized the FDA was chronically slow to approve potentially life-saving treatments in the 80s and passed the Prescription Drug User Fee Act in 1992. This allowed the FDA to collect fees from drug manufacturers as they sought approval for new drugs and, to remedy the bottlenecks of the AIDS crisis, create a faster road to approval and a longer exclusivity period. With the promise of faster, longer revenue streams, pharma development pipelines filled. Compared to the pre-PDUFA world, new drugs now reach approval (or denial) at a much faster rate. The flurry of new drugs mean many disease states now have many multiples of the treatment options available only 10 or 20 years ago. And as options multiplied, it became more advantageous to brand products and reach patients though advertising.

As education and brand awareness became more key, television drug ads picked up, but they looked much different than today. In the mid-90s, most drugs commercials looked a bit more like unbranded campaigns today. The focus was not so much a definitive narrative around one drug, but broad strokes. This avoided repercussions with the FDA but led to confusion among many consumers. By 1997, the renewal of PDUFA, the FDA Modernization Act, and new FDA guidelines clarified the “adequate provisions” from their 1969 guidelines. Drug manufacturers could now direct customers to a phone number, print ad with complete disclosure or a website (some even featured AOL keywords) so that consumers could obtain complete, fair evaluations of the drug, including it’s side effects.

This opened the proverbial floodgates for advertisers. In 1998, the total DTC advertising spend was just over $1.3 billion. Today that is nearly $6 billion. Although the space remains highly regulated, the market has followed the increasingly complex strategies employed in traditional marketing firms. Digital has remade the marketing landscape. Reaching consumers by email, evaluating web site performance, ad metrics, and other digital markers has given rise to robust market research apparatuses, multi- and omnichannel approaches, and complex audience segmentation. Today, agencies create a complex mix of campaigns to raise awareness about certain conditions, place their product in front of patients, and inform doctors of the benefits and drawbacks of their drugs.

And market share has become increasingly important as insurance companies consider market share when considering facets of reimbursement.  

While some have levied the charge that advertising has driven up drug prices or disrupted the doctor-patient relationship, it has also allowed patients unprecedented access to knowledge about the options to remedy their own ailments and conditions. That reflects a particularly American attitude missing from many other places in the globe: that ultimately an individual has both the right to know and co-author their treatment (call that an echo of the right to self-treat) and the ability to make choices as a consumer from a market of competing products.  

The result is a complex mixture of good and bad. The current DTC paradigm has allowed orphan and rare disease diagnoses (with huge help from non-profit disease advocacy organizations) to be diagnosed and treated at significantly higher rates than ever before. With many more treatments available, cancer patients are living longer and have never been better informed about their conditions. Finally, via digital ads and a renewed attention to health equity, we can reach into underserved populations to build trust, address lifestyle disease, and help historically underserved populations lead happier, healthier lives.

At the same time, aggressive marketing contributed to Vioxx’s commercial success in the late 90s, only to be withdrawn from the market for severe cardio vascular side effects, like heart attack. Less successful campaigns, or no campaigns, might have limited the toll from the drug. And advertising also played a role in converting pain into a fourth vital sign and launching the opiate epidemic. The revolution in pharmaceutical marketing of the last 30 years is complex and defies easy categorization as wholly good or bad.

So what does the future hold?

We will probably see the digital marketing landscape continue to change as platforms like X (formerly Twitter) lose or gain trust of digital disease communities, health care practitioners, and, of course, pharmaceutical firms paying to advertise there. More attention will be paid to paving the way for successful launches via HCP and public disease state education. GDPR and the battle over personal identifying information (PII), though mostly used in aggregate for marketing purposes, will continue to be the site of stress between individuals, major corporations, and states. Attribution models have largely been obliterated by the movement from UA3 to GA4. Advertising has regained some of it’s art as the science and analytics have become less certain.

Spanish-language advertising should also take leaps as should targeted segmentation toward historically underserved communities, even if immediate efforts do not show explicit increase ins the number of prescriptions (script lift). Most of all, building/rebuilding trust among segments will also be a key component in the decades to come. Brand might have short-term goals, but enhancing trust in medicine and drug companies will be a decades-long campaign.

In the United States, where most marketing takes places, drug development pipelines will continue to feel stressed by recent questionable FDA approvals, government pressure to reduce prices, insurance profit motives, and, at least for now, costs to borrow. At some point in the future, Medicare/Medicaid negotiation will likely gain more traction, and under the Inflation Reduction Act, monoclonal antibody treatments and novel gene therapies will have at least some additional investment upside. All of this will in turn impact what drugs gain approval, what they treat, and how marketing will need to operate to effectively communicate their value proposition to an increasingly diverse public audience and inundated HCP population. (I’ll look forward to seeing how wrong I was in 10 years).

But perhaps the most telling mark of the way pharmaceutical advertising is now part of American culture is not only how we live with its negative and positive consequences, not only how the future will unfold, but the volume of parodies or jokes hatched in the years since those flood gates have opened.